Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT01710020
Status:
COMPLETED
Last Update Posted:
2012-12-18
First Post:
2012-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pharmacokinetics And Dialysability Of CP-690,550 In Subjects With End-Stage Renal Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C479163', 'term': 'tofacitinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'CP-690,550 (Period 1)', 'description': 'Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.', 'otherNumAtRisk': 12, 'otherNumAffected': 5, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'CP-690,550 (Period 2)', 'description': 'Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.', 'otherNumAtRisk': 11, 'otherNumAffected': 4, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Cough increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 (Period 1)', 'description': 'Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '396', 'spread': '158', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hours (hrs) post-dose in Period 1', 'description': 'AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).', 'unitOfMeasure': 'nanogram*hour/milliliter (ng*hr/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set included all participants who received study medication.'}, {'type': 'PRIMARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 (Period 1)', 'description': 'Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '385', 'spread': '151', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set included all participants who received study medication.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 (Period 1)', 'description': 'Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '106', 'spread': '23.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1', 'unitOfMeasure': 'nanogram/milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set included all participants who received study medication.'}, {'type': 'PRIMARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 (Period 1)', 'description': 'Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '0.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set included all participants who received study medication.'}, {'type': 'PRIMARY', 'title': 'Plasma Decay Half-Life (t1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 (Period 1)', 'description': 'Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.46', 'spread': '1.18', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set included all participants who received study medication.'}, {'type': 'PRIMARY', 'title': 'Oral Clearance (CLpo)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 (Period 1)', 'description': 'Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '501', 'spread': '243', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It was calculated by dividing given dose of drug with AUC.', 'unitOfMeasure': 'milliliter/minute (mL/min)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set included all participants who received study medication.'}, {'type': 'PRIMARY', 'title': 'Dialyser Clearance (CL HD) From 0 to 1 Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 (Period 2)', 'description': 'Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '311', 'spread': '124', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 1 hrs during hemodialysis started 4 hrs post-dose in Period 2', 'description': 'Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided (/) by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu\\*Cmid\\*tm).', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Dialyser Clearance (CL HD) From 1 to 2 Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 (Period 2)', 'description': 'Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '325', 'spread': '138', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 to 2 hrs during hemodialysis started 4 hrs post-dose in Period 2', 'description': 'Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu\\*Cmid\\*tm).', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Dialyser Clearance (CL HD) From 2 to 3 Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 (Period 2)', 'description': 'Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '332', 'spread': '135', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 to 3 hrs during hemodialysis started 4 hrs post-dose in Period 2', 'description': 'Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu\\*Cmid\\*tm).', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Dialyser Clearance (CL HD) From 3 to 4 Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 (Period 2)', 'description': 'Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '292', 'spread': '111', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 to 4 hrs during hemodialysis started 4 hrs post-dose in Period 2', 'description': 'Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu\\*Cmid\\*tm).', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Fraction of Unbound Drug (fu)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 (Period 1)', 'description': 'Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.390', 'spread': '0.042', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 hours post-dose in Period 1', 'description': 'Fraction of unbound drug (fu) is defined as the ratio of unbound drug concentration to the total drug concentration.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Overall Dialyser Clearance (CL HD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 (Period 2)', 'description': 'Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '318', 'spread': '132', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 4 hrs during hemodialysis started 4 hrs post-dose in Period 2', 'description': 'Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu\\*Cmid\\*tm).', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Dialyser Clearance (CL HD) From 3 to 3.5 Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CP-690,550 (Period 2)', 'description': 'Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '377', 'spread': '200', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 to 3.5 hrs during hemodialysis started 4 hrs post-dose in Period 2', 'description': 'Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu\\*Cmid\\*tm).', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CP-690,550 (10 mg OPC)', 'description': 'Single oral dose of CP-690,550 10 milligram (mg) oral powder for constitution (OPC) 1 to 2 hours (hrs) post-hemodialysis in Period 1 followed by single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2. A washout period of at least 14 days was maintained between each intervention period.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Washout Period (at Least 14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population', 'description': 'Includes all participants enrolled in the study.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.9', 'spread': '7.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2003-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-19', 'studyFirstSubmitDate': '2012-10-16', 'resultsFirstSubmitDate': '2012-11-19', 'studyFirstSubmitQcDate': '2012-10-16', 'lastUpdatePostDateStruct': {'date': '2012-12-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-11-19', 'studyFirstPostDateStruct': {'date': '2012-10-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Overall Dialyser Clearance (CL HD)', 'timeFrame': '0 to 4 hrs during hemodialysis started 4 hrs post-dose in Period 2', 'description': 'Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu\\*Cmid\\*tm).'}, {'measure': 'Dialyser Clearance (CL HD) From 3 to 3.5 Hour', 'timeFrame': '3 to 3.5 hrs during hemodialysis started 4 hrs post-dose in Period 2', 'description': 'Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu\\*Cmid\\*tm).'}], 'primaryOutcomes': [{'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hours (hrs) post-dose in Period 1', 'description': 'AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1'}, {'measure': 'Plasma Decay Half-Life (t1/2)', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': 'Oral Clearance (CLpo)', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It was calculated by dividing given dose of drug with AUC.'}, {'measure': 'Dialyser Clearance (CL HD) From 0 to 1 Hour', 'timeFrame': '0 to 1 hrs during hemodialysis started 4 hrs post-dose in Period 2', 'description': 'Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided (/) by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu\\*Cmid\\*tm).'}, {'measure': 'Dialyser Clearance (CL HD) From 1 to 2 Hour', 'timeFrame': '1 to 2 hrs during hemodialysis started 4 hrs post-dose in Period 2', 'description': 'Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu\\*Cmid\\*tm).'}, {'measure': 'Dialyser Clearance (CL HD) From 2 to 3 Hour', 'timeFrame': '2 to 3 hrs during hemodialysis started 4 hrs post-dose in Period 2', 'description': 'Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu\\*Cmid\\*tm).'}, {'measure': 'Dialyser Clearance (CL HD) From 3 to 4 Hour', 'timeFrame': '3 to 4 hrs during hemodialysis started 4 hrs post-dose in Period 2', 'description': 'Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu\\*Cmid\\*tm).'}], 'secondaryOutcomes': [{'measure': 'Fraction of Unbound Drug (fu)', 'timeFrame': '2 hours post-dose in Period 1', 'description': 'Fraction of unbound drug (fu) is defined as the ratio of unbound drug concentration to the total drug concentration.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CP-690', '550', 'pharmacokinetics', 'end-stage renal disease'], 'conditions': ['End-Stage Renal Disease', 'Hemodialysis']}, 'referencesModule': {'references': [{'pmid': '24030917', 'type': 'DERIVED', 'citation': 'Krishnaswami S, Chow V, Boy M, Wang C, Chan G. Pharmacokinetics of tofacitinib, a janus kinase inhibitor, in patients with impaired renal function and end-stage renal disease. J Clin Pharmacol. 2014 Jan;54(1):46-52. doi: 10.1002/jcph.178. Epub 2013 Sep 30.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921004&StudyName=Pharmacokinetics%20And%20Dialysability%20Of%20CP-690%2C550%20In%20Subjects%20With%20End-Stage%20Renal%20Disease', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'There were 2 study periods in this study. In the Period 1, CP-690,550 was to be administered approximately 1 to 2 hours following hemodialysis. If significant non-renal clearance of the drug occurred such that dialyzability of CP-690,550 could not be assessed in Period 1, a second period (Period 2) will be conducted. In Period 2, a single dose of drug will be administered approximately 4 hours prior to hemodialysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with end-stage renal disease\n* Subjects need hemodialysis 3 times weekly\n\nExclusion Criteria:\n\n* Subjects with evidence or history of clinically significant disease, excluding those common for subjects with End-Stage Renal Disease (ESRD).\n* Subjects with any condition possibly affecting drug absorption.\n* Subjects with malignancies with the exception of adequately treated basal cell carcinoma of the skin.'}, 'identificationModule': {'nctId': 'NCT01710020', 'briefTitle': 'Pharmacokinetics And Dialysability Of CP-690,550 In Subjects With End-Stage Renal Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Phase 1, Open-Label Study Of The Pharmacokinetics, Non-Renal Clearance And Dialyzability Of CP-690,550 In Subjects With End-Stage Renal Disease Undergoing Hemodialysis', 'orgStudyIdInfo': {'id': 'A3921004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CP-690,550', 'interventionNames': ['Drug: CP-690,550']}], 'interventions': [{'name': 'CP-690,550', 'type': 'DRUG', 'description': 'CP-690,550 10 mg oral powder for constitution', 'armGroupLabels': ['CP-690,550']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}