Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2026-02-25 @ 4:38 PM
Study NCT ID:
NCT01663103
Status:
COMPLETED
Last Update Posted:
2016-09-12
First Post:
2012-08-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Interleukin-1 Trap to Treat Vascular Dysfunction in Chronic Kidney Disease (CKD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'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': 'C531377', 'term': 'rilonacept'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Kristen.Nowak@ucdenver.edu', 'phone': '303-724-4842', 'title': 'Dr. Kristen Nowak', 'organization': 'University of Colorado Anschutz Medical Campus'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Rilonacept', 'description': '12 weeks of treatment with rilonacept\n\nRilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)', 'otherNumAtRisk': 21, 'otherNumAffected': 5, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Twelve weeks of treatment with placebo\n\nPlacebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)', 'otherNumAtRisk': 21, 'otherNumAffected': 2, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Neck abscess/pyomyositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Flow-mediated Dilation (FMD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rilonacept', 'description': '12 weeks of treatment with rilonacept\n\nRilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Twelve weeks of treatment with placebo\n\nPlacebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months after start of treatment', 'description': 'Change in FMD after 3 months of treatment with rilonacept will be compared to change in the placebo group.', 'unitOfMeasure': 'change in percent flow-mediated dilation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Aortic Pulse-wave Velocity (aPWV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rilonacept', 'description': '12 weeks of treatment with rilonacept\n\nRilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Twelve weeks of treatment with placebo\n\nPlacebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'spread': '65', 'groupId': 'OG000'}, {'value': '2', 'spread': '71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months after start of treatment', 'description': 'Change in aPWV after 3 months of treatment with rilonacept will be compared to change in the placebo group.', 'unitOfMeasure': 'change in pulse-wave velocity (cm/sec)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Contribution of Oxidative Stress to FMD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Rilonacept: Baseline', 'description': 'Change in flow-mediated dilation following an acute infusion of ascorbic acid (as compared to saline) in the rilonacept group at baseline.'}, {'id': 'OG001', 'title': 'Rilonacept: End of Study', 'description': 'Change in flow-mediated dilation following an acute infusion of ascorbic acid (as compared to saline) in the rilonacept group at 12 weeks.'}, {'id': 'OG002', 'title': 'Placebo: Baseline', 'description': 'Change in flow-mediated dilation following an acute infusion of ascorbic acid (as compared to saline) in the placebo group at baseline'}, {'id': 'OG003', 'title': 'Placebo: End of Study', 'description': 'Change in flow-mediated dilation following an acute infusion of ascorbic acid (as compared to saline) in the placebo group at baseline'}], 'classes': [{'categories': [{'measurements': [{'value': '0.16', 'spread': '2.52', 'groupId': 'OG000'}, {'value': '0.51', 'spread': '2.24', 'groupId': 'OG001'}, {'value': '-0.04', 'spread': '1.96', 'groupId': 'OG002'}, {'value': '0.69', 'spread': '1.73', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months after start of treatment', 'description': 'FMD will be assessed following acute infusion of ascorbic acid compared to saline. The improvement in FMD with ascorbic acid reflects the degree of oxidative stress contributing to impairment in FMD.', 'unitOfMeasure': 'change in percent flow-mediated dilation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'sub-group from Denver site'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in High-sensitivity C-reactive Protein (hsCRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rilonacept', 'description': '12 weeks of treatment with rilonacept\n\nRilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Twelve weeks of treatment with placebo\n\nPlacebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.02', 'groupId': 'OG000', 'lowerLimit': '-2.9', 'upperLimit': '1.3'}, {'value': '0.16', 'groupId': 'OG001', 'lowerLimit': '-0.82', 'upperLimit': '1.19'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 months after start of treatment', 'description': 'Change in high-sensitivity C-reactive protein (hsCRP) after 3 months of rilonacept vs. placebo will be assessed as a circulating marker of inflammation.', 'unitOfMeasure': 'change in c-reactive protein (mg/L)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Vascular Endothelial NADPH Oxidase Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rilonacept', 'description': '12 weeks of treatment with rilonacept\n\nRilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Twelve weeks of treatment with placebo\n\nPlacebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months after start of treatment', 'description': 'Vascular endothelial cells will be collected and assessed for changes in protein expression of NADPH oxidase after 3 months of treatment with rilonacept vs. placebo. Protein expression is calculated as a ratio of intensity of staining in the patient cells relative to human umbilical vein endothelial cell (HUVEC) control cells. The absolute change in this ratio between baseline and week 12 is reported below.', 'unitOfMeasure': 'absolute change in ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'sub-group from Denver site'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rilonacept', 'description': '12 weeks of treatment with rilonacept\n\nRilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Twelve weeks of treatment with placebo\n\nPlacebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'dog bite', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rilonacept', 'description': '12 weeks of treatment with rilonacept\n\nRilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Twelve weeks of treatment with placebo\n\nPlacebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61', 'spread': '11', 'groupId': 'BG000'}, {'value': '65', 'spread': '11', 'groupId': 'BG001'}, {'value': '63', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Etiology of CKD', 'classes': [{'title': 'Hypertension', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Type II Diabetes', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Type I DIabetes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Autosomal Dominant Polycystic Kidney Disease', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Renal Cell Carcinoma', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Focal Segmental Glomerulosclerosis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Estimated glomerular filtration rate', 'classes': [{'categories': [{'measurements': [{'value': '38', 'spread': '14', 'groupId': 'BG000'}, {'value': '38', 'spread': '12', 'groupId': 'BG001'}, {'value': '38', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mL/min/1.73m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-02', 'studyFirstSubmitDate': '2012-08-07', 'resultsFirstSubmitDate': '2016-04-06', 'studyFirstSubmitQcDate': '2012-08-08', 'lastUpdatePostDateStruct': {'date': '2016-09-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-08-02', 'studyFirstPostDateStruct': {'date': '2012-08-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in High-sensitivity C-reactive Protein (hsCRP)', 'timeFrame': '3 months after start of treatment', 'description': 'Change in high-sensitivity C-reactive protein (hsCRP) after 3 months of rilonacept vs. placebo will be assessed as a circulating marker of inflammation.'}, {'measure': 'Change in Vascular Endothelial NADPH Oxidase Expression', 'timeFrame': '3 months after start of treatment', 'description': 'Vascular endothelial cells will be collected and assessed for changes in protein expression of NADPH oxidase after 3 months of treatment with rilonacept vs. placebo. Protein expression is calculated as a ratio of intensity of staining in the patient cells relative to human umbilical vein endothelial cell (HUVEC) control cells. The absolute change in this ratio between baseline and week 12 is reported below.'}], 'primaryOutcomes': [{'measure': 'Change in Flow-mediated Dilation (FMD)', 'timeFrame': '3 months after start of treatment', 'description': 'Change in FMD after 3 months of treatment with rilonacept will be compared to change in the placebo group.'}], 'secondaryOutcomes': [{'measure': 'Change in Aortic Pulse-wave Velocity (aPWV)', 'timeFrame': '3 months after start of treatment', 'description': 'Change in aPWV after 3 months of treatment with rilonacept will be compared to change in the placebo group.'}, {'measure': 'Change in Contribution of Oxidative Stress to FMD', 'timeFrame': '3 months after start of treatment', 'description': 'FMD will be assessed following acute infusion of ascorbic acid compared to saline. The improvement in FMD with ascorbic acid reflects the degree of oxidative stress contributing to impairment in FMD.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Interleukin-1', 'Endothelium, Vascular', 'Vascular Stiffness', 'Oxidative Stress', 'Inflammation', 'Endothelial cells'], 'conditions': ['Renal Insufficiency, Chronic']}, 'descriptionModule': {'briefSummary': 'Risk of cardiovascular diseases (CVD) is significantly elevated in patients with chronic kidney disease (CKD); however, this increased risk is only partially explained by traditional cardiovascular risk factors. Patients with CKD exhibit chronic inflammation, a key mechanism contributing to vascular dysfunction (i.e., large elastic artery stiffening and endothelial dysfunction). Inhibiting inflammation improves vascular dysfunction in other populations characterized by chronic inflammation. However, it is currently unknown if reducing inflammation with an interleukin-1 (IL-1) blocker enhances vascular function in CKD patients. Aim 1 will assess the efficacy of IL-1 blocking with rilonacept for treating vascular dysfunction in patients with stage III or IV CKD (estimated glomerular filtration rate 15-60 mL/min/1.73 m2). Aim 2 will determine if blocking IL-1 with rilonacept also reduces inflammation and oxidative stress. These studies could shift clinical practice guidelines by establishing a novel therapy for reducing CVD risk in CKD patients not requiring chronic hemodialysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-80 years\n* CKD stage III or IV (eGFR with the 4-variable Modified Diet Renal Disease (MDRD) prediction equation: 15-60 mL/min/1.73m2; stable renal function in the past 3 months)\n* An elevated high sensitivity C-reactive protein (hs-CRP) of \\> 2.0 mg/L and \\<30 mg/L on at least 2 consecutive weekly determinations\n* Urine protein excretion \\< 5.0 g/24h estimated by a spot urine protein/creatinine ratio\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Patients with advanced CKD requiring chronic dialysis\n* Active infection (chronic or acute (within 3 months) or antibiotic therapy (w/in 1 mo); history of recurrent infection\n* Significant co-morbid conditions that lead the investigator to conclude that life expectancy is less than 1 year\n* Expected to undergo living related transplant in next 6 months\n* History of severe congestive heart failure (i.e., EF \\< 35%)\n* Hospitalization in the past month\n* Severe arthritis, lupus, inflammatory bowel disease, asthma or other disease(s) or medical condition(s) that, in the opinion of the investigator, could interfere with hsCRP or immune function\n* Immunosuppressant agents such as cyclosporine, tacrolimus, azathioprine, etanercept, infliximab, adalimumab, anakinra or long-term oral glucocorticoids taken in past 12 months\n* Known malignancy\n* HIV, active, chronic hepatitis B as evidenced by HBsAg positive and HBsAb negative, or hepatitis C positive\n* Woman who are pregnant, nursing or planning to become pregnant\n* Body mass index (BMI) \\>40 kg/m2\n* Warfarin use (or other cytochrome P (CYP)450 substrates with a narrow therapeutic index) \\[ok if do not participate in endothelial cell collection\\]\n* Taking medication(s) that interact with agents administered during experimental sessions (e.g., sildenafil interacts with nitroglycerin)\n* Currently receiving or planning to receive live or inactivated vaccines\n* Alcohol dependence or abuse\n* Subjects at risk for tuberculosis (TB). Specifically, subjects with:\n* Current clinical, radiographic or laboratory evidence of active TB at screening or latent TB that has not been previously treated\n* A history of active TB within the last 3 years even if it was treated.\n* A history of active TB greater than 3 years ago unless there is documentation that the prior anti-TB treatment was appropriate in duration and type.\n* Therapy for latent TB which has not been completed as per local guidelines.'}, 'identificationModule': {'nctId': 'NCT01663103', 'briefTitle': 'Interleukin-1 Trap to Treat Vascular Dysfunction in Chronic Kidney Disease (CKD)', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Interleukin-1 Trap to Treat Vascular Dysfunction in Chronic Kidney Disease (CKD)', 'orgStudyIdInfo': {'id': '12-0586'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rilonacept', 'description': '12 weeks of treatment with rilonacept', 'interventionNames': ['Drug: Rilonacept']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Twelve weeks of treatment with placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Rilonacept', 'type': 'DRUG', 'otherNames': ['Arcalyst'], 'description': '12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)', 'armGroupLabels': ['Rilonacept']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['normal saline'], 'description': 'Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Clinical and Translational Research Center (CTRC) Outpatient Clinic', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Kristen L Jablonski Nowak, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado Denver Anschutz Medical Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}