Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-01-04 @ 8:37 AM
Study NCT ID:
NCT06723535
Status:
COMPLETED
Last Update Posted:
2025-10-14
First Post:
2024-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate BMS-986278 in Participants With Normal Renal Function, Severe Renal Impairment, or End-Stage Renal Disease on Intermittent Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-09-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-10', 'studyFirstSubmitDate': '2024-12-04', 'studyFirstSubmitQcDate': '2024-12-04', 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed concentration (Cmax)', 'timeFrame': 'Up to Day 8'}, {'measure': 'Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]', 'timeFrame': 'Up to Day 8'}, {'measure': 'Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]', 'timeFrame': 'Up to Day 8'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events (AEs)', 'timeFrame': 'Up to 28 days following discontinuation of dosing'}, {'measure': 'Number of participants with physical examination abnormalities', 'timeFrame': 'Up to Day 8'}, {'measure': 'Number of participants with vital sign abnormalities', 'timeFrame': 'Up to Day 8'}, {'measure': 'Number of participants with 12-lead electrocardiogram (ECG) abnormalities', 'timeFrame': 'Up to Day 8'}, {'measure': 'Number of participants with clinical laboratory abnormalities', 'timeFrame': 'Up to Day 8'}, {'measure': 'Time of maximum observed concentration (Tmax)', 'timeFrame': 'Up to Day 8'}, {'measure': 'Terminal elimination half-life (T-HALF)', 'timeFrame': 'Up to Day 8'}, {'measure': 'Apparent body clearance (CLT/F)', 'timeFrame': 'Up to Day 8'}, {'measure': 'Apparent volume of distribution of terminal phase (Vz/F)', 'timeFrame': 'Up to Day 8'}, {'measure': 'Concentration of BMS-986278 in dialysate', 'timeFrame': 'Up to Day 8'}, {'measure': 'Total amount recovered in dialysate (DR)', 'timeFrame': 'Up to Day 8'}, {'measure': 'Total percent of administered dose recovered in dialysate (%DR)', 'timeFrame': 'Up to Day 8'}, {'measure': 'Free fraction of unbound drug (Fu)', 'timeFrame': 'Up to Day 8'}, {'measure': 'Unbound Cmax (Cmax_u)', 'timeFrame': 'Up to Day 8'}, {'measure': 'Unbound AUC(0-T) (AUC(0-T) _u)', 'timeFrame': 'Up to Day 8'}, {'measure': 'Unbound AUC(INF) (AUC(INF)_u)', 'timeFrame': 'Up to Day 8'}, {'measure': 'Unbound CLT/F (CLT/F_u)', 'timeFrame': 'Up to Day 8'}, {'measure': 'Unbound Vz/F (Vz/F_u)', 'timeFrame': 'Up to Day 8'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Failure, Chronic', 'Healthy Volunteers', 'Renal Impairment']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of severe renal impairment (RI) and end-stage renal disease (ESRD) with intermittent hemodialysis (IHD) on the pharmacokinetics and safety of BMS-986278. This study plans to use a staged design based on RI severity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) between 18 and 45 kg/m2 inclusive, and body weight ≥ 50 kg at screening. Note: for ESRD participants, this body weight should be the prescription dry weight.\n* Severe Renal Impaired Participants:\n\n 1. Participant has a supine SBP ≥ 90 and ≤ 180 mmHg, supine DBP ≥ 60 and ≤ 100 mmHg, and heart rate ≥ 40 and ≤ 110 beats per minute.\n 2. Participant has severe RI as defined by an eGFR ˂ 30 mL/min and not requiring dialysis at screening.\n 3. Participant must be medically stable for at least 1 month before study intervention administration.\n* Participants with ESRD:\n\n 1. Participant has ESRD as defined by an eGFR \\< 15 mL/min at screening.\n 2. Participant required to be on intermittent hemodialysis, an average of 3 hemodialysis treatments per week prior to screening.\n 3. Participant has demonstrated adequate hemodialysis measurements (at least 2 Kt/V measurements ≥ 1.2 or 2 urea reduction ratio measurements ≥ 65%) within the 3 months prior to screening.\n* Healthy participant should have a supine SBP ≥ 90 and ≤ 160 mm Hg, supine DBP ≥ 50 and ≤ 100 mm Hg, and heart rate ≥ 40 and ≤ 100 beats per minute.\n* Healthy participants should have normal renal function, as defined by having an eGFR ≥ 90 mL/min eGFR at screening (calculated using the CKD-EPI equation).\n\nExclusion Criteria:\n\n* Participant with any significant medical condition, laboratory abnormality, or psychiatric illness.\n* Any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, or excretion (eg, bariatric procedure or cholecystectomy).\n* Individuals who are of childbearing potential, breastfeeding, or currently pregnant.\n* Other protocol defined inclusion/exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT06723535', 'briefTitle': 'A Study to Evaluate BMS-986278 in Participants With Normal Renal Function, Severe Renal Impairment, or End-Stage Renal Disease on Intermittent Hemodialysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'An Open-Label, Single-Dose, Phase 1 Study to Evaluate the Pharmacokinetics and Safety of BMS-986278 in Participants With Normal Renal Function, Participants With Severe Renal Impairment, and Participants With End-Stage Renal Disease on Intermittent Hemodialysis', 'orgStudyIdInfo': {'id': 'IM027-1014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A and C', 'interventionNames': ['Drug: BMS-986278']}, {'type': 'EXPERIMENTAL', 'label': 'Group B: Period 1', 'interventionNames': ['Drug: BMS-986278']}, {'type': 'EXPERIMENTAL', 'label': 'Group B: Period 2', 'interventionNames': ['Drug: BMS-986278']}], 'interventions': [{'name': 'BMS-986278', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Group A and C', 'Group B: Period 1', 'Group B: Period 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33147-4040', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution - 0002', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33172', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution - 0003', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32808-7820', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution - 0004', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32809-3017', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Clinical Research Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'See plan description', 'ipdSharing': 'YES', 'description': "BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.\n\nAdditional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html", 'accessCriteria': 'See plan description'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}