Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-02-12 @ 6:20 AM
Study NCT ID:
NCT02327403
Status:
COMPLETED
Last Update Posted:
2022-11-09
First Post:
2014-12-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Belatacept Conversion in Proteinuric Kidney Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011507', 'term': 'Proteinuria'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'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': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069594', 'term': 'Abatacept'}], 'ancestors': [{'id': 'D018796', 'term': 'Immunoconjugates'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'LRIELLA@MGH.HARVARD.EDU', 'phone': '6176436266', 'title': 'Dr. Leonardo V Riella, MD, PhD', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Belatacept Conversion', 'description': 'Kidney Transplant recipients with proteinuria who converted their immunosuppression from CNI to belatacept-based maintenance therapy', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 9, 'seriousNumAtRisk': 15, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Shingles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'MRSA Cellulitis with Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Kidney Injury', 'notes': 'Due to interstitial inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Basal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Recurrence of Bladder Tumor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Cardiac Arrest', 'notes': 'Cardiac arrest leading to death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Proteinuria by 25%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept Conversion', 'description': 'Belatacept: Conversion from calcineurin-inhibitor to Belatacept maintenance immunosuppression.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Change in proteinuria by 25%: daily proteinuria is estimated by spot urine protein (mg/dL) to creatinine (mg/dL) ratio at baseline (before the belatacept conversion) and post-conversion 12 months; and interval % change was calculated by getting the ratio of difference between the two time points to the baseline value.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Renal Function (eGFR in mL/Min/1.73 m^2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept Conversion', 'description': 'Kidney Transplant recipients with proteinuria who converted their immunosuppression from CNI to belatacept-based maintenance therapy'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '45.8', 'spread': '13.3', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '45.1', 'spread': '12.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from baseline to 12 months', 'unitOfMeasure': 'mL/min/1.73m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Acute Rejection Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept Conversion', 'description': 'Kidney Transplant recipients with proteinuria who converted their immunosuppression from CNI to belatacept-based maintenance therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Acute rejection episodes \\[Time Frame: 12 months\\]: Number of biopsy-proven rejection episodes from belatacept conversion to post-conversion 12 months.', 'unitOfMeasure': 'episodes', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Blood Pressure Measurement (mm Hg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept Conversion', 'description': 'Kidney Transplant recipients with proteinuria who converted their immunosuppression from CNI to belatacept-based maintenance therapy'}], 'classes': [{'title': 'Baseline (Systolic)', 'categories': [{'measurements': [{'value': '140', 'spread': '11', 'groupId': 'OG000'}]}]}, {'title': 'Baseline (Diastolic)', 'categories': [{'measurements': [{'value': '76', 'spread': '6', 'groupId': 'OG000'}]}]}, {'title': '12 Months (Systolic)', 'categories': [{'measurements': [{'value': '129', 'spread': '16', 'groupId': 'OG000'}]}]}, {'title': '12 Months (Diastolic)', 'categories': [{'measurements': [{'value': '72', 'spread': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Change in Blood pressure measurement (mm Hg) \\[Time Frame: 12 months\\]: The mmHg difference in systolic and diastolic blood pressures between the baseline (pre-belatacept conversion) and post-conversion 12 months is assessed. Blood pressure measurement done at the office visits at baseline and 12 months after at least 5 minutes of resting.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept Conversion', 'description': 'Kidney Transplant recipients with proteinuria who converted their immunosuppression from CNI to belatacept-based maintenance therapy'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '119', 'spread': '37', 'groupId': 'OG000'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '124', 'spread': '62', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'New onset diabetes \\[Time Frame: 12 months\\]: Number of new onset diabetes per American Diabetes Association 2015 Criteria from belatacept conversion to post-conversion 12 months', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hyperlipidemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept Conversion', 'description': 'Kidney Transplant recipients with proteinuria who converted their immunosuppression from CNI to belatacept-based maintenance therapy'}], 'classes': [{'title': 'Baseline Total Cholesterol', 'categories': [{'measurements': [{'value': '177', 'spread': '49', 'groupId': 'OG000'}]}]}, {'title': '12 Month Total Cholesterol', 'categories': [{'measurements': [{'value': '171', 'spread': '49', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Hyperlipidemia \\[ Time Frame: 12 months\\]: Changes (mg/dL) in serum total cholesterol, LDL, HDL, and triglyceride levels from pre-belatacept conversion to post-conversion 12 months.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Graft Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept Conversion', 'description': 'Kidney Transplant recipients with proteinuria who converted their immunosuppression from CNI to belatacept-based maintenance therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Graft survival \\[Time Frame: 12 months\\]: Number of patients who developed end stage kidney disease and required kidney replacement therapy within 12 months post-belatacept conversion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept Conversion', 'description': 'Kidney Transplant recipients with proteinuria who converted their immunosuppression from CNI to belatacept-based maintenance therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Belatacept Conversion', 'description': 'Kidney Transplant recipients with proteinuria who converted their immunosuppression from CNI to belatacept-based maintenance therapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Belatacept Conversion', 'description': 'Belatacept: Conversion from calcineurin-inhibitor to Belatacept maintenance immunosuppression.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '12', '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': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Black', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Hispanic', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-09', 'size': 1437596, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-08-17T13:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-17', 'studyFirstSubmitDate': '2014-12-22', 'resultsFirstSubmitDate': '2022-08-24', 'studyFirstSubmitQcDate': '2014-12-24', 'lastUpdatePostDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-17', 'studyFirstPostDateStruct': {'date': '2014-12-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Proteinuria by 25%', 'timeFrame': '12 months', 'description': 'Change in proteinuria by 25%: daily proteinuria is estimated by spot urine protein (mg/dL) to creatinine (mg/dL) ratio at baseline (before the belatacept conversion) and post-conversion 12 months; and interval % change was calculated by getting the ratio of difference between the two time points to the baseline value.'}], 'secondaryOutcomes': [{'measure': 'Change in Renal Function (eGFR in mL/Min/1.73 m^2)', 'timeFrame': 'from baseline to 12 months'}, {'measure': 'Acute Rejection Episodes', 'timeFrame': '12 months', 'description': 'Acute rejection episodes \\[Time Frame: 12 months\\]: Number of biopsy-proven rejection episodes from belatacept conversion to post-conversion 12 months.'}, {'measure': 'Change in Blood Pressure Measurement (mm Hg)', 'timeFrame': '12 months', 'description': 'Change in Blood pressure measurement (mm Hg) \\[Time Frame: 12 months\\]: The mmHg difference in systolic and diastolic blood pressures between the baseline (pre-belatacept conversion) and post-conversion 12 months is assessed. Blood pressure measurement done at the office visits at baseline and 12 months after at least 5 minutes of resting.'}, {'measure': 'Change in Fasting Glucose', 'timeFrame': '12 months', 'description': 'New onset diabetes \\[Time Frame: 12 months\\]: Number of new onset diabetes per American Diabetes Association 2015 Criteria from belatacept conversion to post-conversion 12 months'}, {'measure': 'Hyperlipidemia', 'timeFrame': '12 months', 'description': 'Hyperlipidemia \\[ Time Frame: 12 months\\]: Changes (mg/dL) in serum total cholesterol, LDL, HDL, and triglyceride levels from pre-belatacept conversion to post-conversion 12 months.'}, {'measure': 'Graft Survival', 'timeFrame': '12 months', 'description': 'Graft survival \\[Time Frame: 12 months\\]: Number of patients who developed end stage kidney disease and required kidney replacement therapy within 12 months post-belatacept conversion.'}, {'measure': 'Patient Survival', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Proteinuria', 'Kidney transplantation', 'Allograft dysfunction', 'B7-1', 'Belatacept'], 'conditions': ['Proteinuria']}, 'descriptionModule': {'briefSummary': 'Background: Proteinuria develops in about 30% of kidney transplant recipients and is a strong predictor of graft loss. The amount of proteinuria has a direct correlation with the risk of graft failure. Novel therapies are urgently needed to reduce proteinuria and prevent graft loss in transplant recipients, since ACE inhibitors carry a number of limitations in the transplant setting, including significant reduction in renal function, anemia and hyperkalemia.\n\nPreliminary data: B7-1 is expressed at significant levels in about 10% of kidney allograft biopsies with predominance in patients with proteinuria.\n\nHypothesis: We hypothesize that B7-1 targeting therapy may reduce proteinuria and improve graft survival in proteinuric transplant recipients that have B7-1 staining on allografts. In addition, the absence of CNI nephrotoxicity and the potential protective effect of Belatacept on DSA production may be of benefit in this subset of transplant patients.\n\nObjectives:\n\nPrimary: Determine the effect of Belatacept conversion in reducing proteinuria by 25% at 12 months in renal transplant recipients (≥1gram/d) that are either B7-1-positive or negative on kidney biopsy.\n\nSecondary: Assess the effect of Belatacept conversion in the percent change of renal function from baseline to 12 months; donor-specific anti-HLA antibodies presence and intensity (MFI); correlation of B7-1 positivity on immunofluorescence on biopsy with B7-1-expression in urine extracellular vesicles; adverse events; acute rejection episodes; blood pressure control; new onset diabetes; hyperlipidemia; graft survival; and patient survival.', 'detailedDescription': 'A total of 36 patients will be recruited.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female adult kidney transplant recipients older than 18 years old\n2. eGFR ≥30 ml/min\n3. ≥6 months after transplantation\n4. Proteinuria ≥1 gram/day in spot urine protein/creatinine ratio\n5. Ability to provide written informed consent for the study.\n6. Maintenance immunosuppression of CNI (cyclosporine or tacrolimus), antiproliferative agent (azathioprine, MMF or MPA) with either steroids or not.\n\nExclusion Criteria:\n\n1. Age \\<18 years\n2. eGFR\\<30 ml/min\n3. active acute cellular rejection (ACR; higher than borderline) or ACR in the previous 6 months; active acute antibody-mediated rejection\n4. recurrent FSGS\n5. EBV IgG negative\n6. patient on mTOR inhibitor (e.g. Everolimus, Sirolimus)\n7. patient only on CNI (cyclosporine or tacrolimus) and steroids'}, 'identificationModule': {'nctId': 'NCT02327403', 'briefTitle': 'Belatacept Conversion in Proteinuric Kidney Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'The B7-1 Study": Belatacept Conversion in Proteinuric Renal Transplant Recipients: an Interventional Multi-Center Trial', 'orgStudyIdInfo': {'id': '2015P000154'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Proteinuric Kidney Transplant Recipients', 'description': 'Belatacept conversion', 'interventionNames': ['Drug: Belatacept']}], 'interventions': [{'name': 'Belatacept', 'type': 'DRUG', 'description': 'Conversion from calcineurin-inhibitor to Belatacept maintenance immunosuppression.', 'armGroupLabels': ['Proteinuric Kidney Transplant Recipients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Leonardo V Riella, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Leonardo V. Riella, MD PhD', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}