Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-03-28 @ 6:51 AM
Study NCT ID:
NCT02933450
Status:
COMPLETED
Last Update Posted:
2019-05-09
First Post:
2016-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Relypsa For ED Acute Hyperkalemia Control and Reduction (REDUCE)
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': 'C568789', 'term': 'patiromer'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'zubaidrafique@gmail.com', 'phone': '7138732626', 'title': 'Dr Zubaid Rafiue', 'organization': 'Emergency Department, Baylor College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected up to 6hrs', 'eventGroups': [{'id': 'EG000', 'title': 'Patiromer', 'description': 'Subjects receiving a single dose of Patiromer 25.2 g + Standard of Care therapy', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 4, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard of Care', 'description': 'subjects receiving standard of care therapy', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 5, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'GI Side Effects', 'notes': 'Nausea, vomiting, diarrhea, constipation, abdominal bloating or pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycemia', 'notes': 'Blood sugar \\< 70 mg/dL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficacy of Patiromer in Reducing Serum Potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patiromer', 'description': 'Subjects receiving a single dose of Patiromer 25.2 g + Standard of Care therapy'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'subjects receiving standard of care therapy'}], 'classes': [{'title': '1 hr', 'categories': [{'measurements': [{'value': '6.17', 'groupId': 'OG000', 'lowerLimit': '5.94', 'upperLimit': '6.46'}, {'value': '6.6', 'groupId': 'OG001', 'lowerLimit': '6.33', 'upperLimit': '6.86'}]}]}, {'title': '2 hr', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.67', 'upperLimit': '6.2'}, {'value': '6.47', 'groupId': 'OG001', 'lowerLimit': '6.21', 'upperLimit': '6.73'}]}]}, {'title': '4 hr', 'categories': [{'measurements': [{'value': '5.73', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '6.02'}, {'value': '6.04', 'groupId': 'OG001', 'lowerLimit': '5.77', 'upperLimit': '6.30'}]}]}, {'title': '6 hr', 'categories': [{'measurements': [{'value': '5.81', 'groupId': 'OG000', 'lowerLimit': '5.51', 'upperLimit': '6.16'}, {'value': '6.27', 'groupId': 'OG001', 'lowerLimit': '5.97', 'upperLimit': '6.58'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 hours', 'description': 'serial serum potassium levels will be graphed and compared between the 2 groups', 'unitOfMeasure': 'mEq/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tolerability of High Dose Patiromer in ESRD Patients on Hemodialysis in the Acute Setting.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patiromer', 'description': 'Subjects receiving a single dose of Patiromer 25.2 g + Standard of Care therapy'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'subjects receiving standard of care therapy'}], 'classes': [{'title': 'Total', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'GI side effects', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycemia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Hypomagnesemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 hours', 'description': 'adverse events will be recorded and compared between the 2 groups', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patiromer', 'description': 'Single dose of Patiromer 25.2 g + Standard of Care'}, {'id': 'FG001', 'title': 'Standard of Care', 'description': 'Standard of Care'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Patiromer Group', 'description': 'Single dose of Patiromer 25.2 g + Standard of Care'}, {'id': 'BG001', 'title': 'Standard of Care Group', 'description': 'Standard of Care'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000', 'lowerLimit': '36', 'upperLimit': '50'}, {'value': '48', 'groupId': 'BG001', 'lowerLimit': '39', 'upperLimit': '52'}, {'value': '43', 'groupId': 'BG002', 'lowerLimit': '36', 'upperLimit': '52'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-21', 'size': 233137, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-05-07T16:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-07', 'studyFirstSubmitDate': '2016-08-25', 'resultsFirstSubmitDate': '2019-02-07', 'studyFirstSubmitQcDate': '2016-10-12', 'lastUpdatePostDateStruct': {'date': '2019-05-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-07', 'studyFirstPostDateStruct': {'date': '2016-10-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of Patiromer in Reducing Serum Potassium', 'timeFrame': '6 hours', 'description': 'serial serum potassium levels will be graphed and compared between the 2 groups'}], 'secondaryOutcomes': [{'measure': 'Tolerability of High Dose Patiromer in ESRD Patients on Hemodialysis in the Acute Setting.', 'timeFrame': '6 hours', 'description': 'adverse events will be recorded and compared between the 2 groups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Kidney Failure, Chronic']}, 'descriptionModule': {'briefSummary': 'The Investigator hypothesize that a single dose of patiromer will lower serum potassium levels in less than 6hrs. Since a dosage of 30g/day for a period of 4 weeks has been studied in at least two multicenter randomized controlled trials, the Investigator further hypothesize that a single dose of 25.2g of patiromer will be well tolerated in hyperkalemic patients in the Emergency Department setting. The FDA approved dosage of 25.2g is appropriate for this study because the research staff will enroll patients with moderate (K greater than 6 mEq/L) to severe hyperkalemia, and the higher dosage has typically been used in this population for more effective control.', 'detailedDescription': 'This is an open label pilot study. Thirty patients with ESRD who qualify for emergent dialysis on the basis of serum potassium greater than 6mEq/L will be randomly assigned, using a random number generator in blocks of sixes, to standard-of-care (standard care) or patiromer group. Patients in the patiromer group will be given a single dose of 25.2g of patiromer in addition to standard-of-care treatment after randomization. Standard-of-care is defined as intervention or care provided by clinical provider according to individual practice pattern or hospital protocol. Each group of 15 patients will be observed with telemetry monitoring for 10 hours or till hemodialysis units become available for treatment (whichever comes first). Blood draws and electrocardiograms (ECGs) will be performed at enrollment and at 1, 2, 4, 6, 8 and 10hrs thereafter. Serum will be analyzed for basic metabolic panel and magnesium. Medications, including potassium lowering agents, administered during this period will be documented.\n\n1\\. Informed consent will be obtained. 2. Subject will be randomized. 3. A. Randomized to Standard of Care (SOC): data will be collected on SOC treatment. 3. B. Randomized to patiromer group: subjects will receive a single dose of 25.2g of patiromer. SOC data will be collected. 4. all subjects will have blood drawn and ECGs (1 12 lead ECG and 1 Lead I Rhythm strip) done at baseline, 1, 2, 4, 6, 8 and 10 hours. Blood will be analyzed for basic metabolic panel and magnesium. 5. CRF completion-SOC data will be recorded in addition to current medications. 6. After subjects have received hemodialysis or reach the 10 hour study period, whichever comes first, the subject will be completed on the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ESRD patients with serum potassium greater than or equal to 6.0 mEq/L\n* Emergent dialysis not expected to be available for 6 hours\n\nExclusion Criteria:\n\n* new clinically significant arrhythmia on initial ECG\n* patiromer is contraindicated\n* have received SPS'}, 'identificationModule': {'nctId': 'NCT02933450', 'briefTitle': 'Relypsa For ED Acute Hyperkalemia Control and Reduction (REDUCE)', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Relypsa For ED Acute Hyperkalemia Control and Reduction (REDUCE)', 'orgStudyIdInfo': {'id': 'H-39340'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patiromer group', 'description': 'Patiromer 25.2 g dose', 'interventionNames': ['Drug: Patiromer 25.2 g']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care group', 'description': 'Standard of Care'}], 'interventions': [{'name': 'Patiromer 25.2 g', 'type': 'DRUG', 'description': 'Single dose of Patiromer 25.2 g', 'armGroupLabels': ['Patiromer group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Ben Taub Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Zubaid Rafique, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data will be coded and shared with the sponsor'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Relypsa, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zubaid Rafique', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}