A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based

This study is currently recruiting participants.
Verified September 2013 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01820572
First received: March 14, 2013
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

The primary purpose is to assess the benefits and risks of changing from Cyclosporine or Tacrolimus to Belatacept between 6-36 months after kidney transplant.


Condition Intervention Phase
Kidney Transplantation
Drug: Belatacept
Drug: Tacrolimus
Drug: Cyclosporine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Benefits and Risks in Maintenance Renal Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based Immunosuppression

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Proportion of subjects who survive with a functional graft at 24 months post randomization [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Patient and Graft Survival - Proportion of subjects who survive with a functional graft at 12 months post-randomization [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • Incidence of acute rejection (AR) post-randomization [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Severity of AR post-randomization [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Renal Function - Mean change in cGFR (MDRD) from baseline to 12 and 24 months post-randomization (% and absolute) [ Time Frame: Baseline (Day 1) to 12 and 24 months ] [ Designated as safety issue: No ]
  • Renal Function - Slopes of cGFR and 1/serum creatinine respectively from baseline as well as Month 3 to 12 and 24 months post-randomization [ Time Frame: Baseline (Day 1), 3 to 12 and 24 months ] [ Designated as safety issue: No ]
  • Renal Function - Proportion of subjects with >5% and >10% improvement over baseline in cGFR at 12 and 24 months post-randomization [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Renal Function - Urine protein/creatinine ratio (UPCR) at baseline, 3, 6, 12 and 24 months post-randomization [ Time Frame: Baseline (Day 1), 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Hypertension - Mean change in systolic and diastolic blood pressure from baseline to 12 and 24 months post-randomization, and intensity of anti-hypertensive treatment regimens from baseline to 12 and 24 months [ Time Frame: Baseline (Day 1) to 12 and 24 months ] [ Designated as safety issue: No ]
  • Donor Specific Antibodies (DSA) - Proportion of donor specific antibodies (DSA) at 12 and 24 months post-randomization [ Time Frame: 12 and 24 Months ] [ Designated as safety issue: No ]
  • Occurrence of symptom occurrence and symptom distress measured with the Modified Transplant Symptom Occurrence and Symptom Distress Scale-59R (MTSOSDS-R 59) at baseline, Week 6, and 3, 6, and 12 months post-randomization [ Time Frame: Baseline (Day 1), Week 6 and 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • Safety and tolerability of a Belatacept-based immunosuppressive regimen-Proportions and incidence rates of all AEs, AEs of special interest, Clinically significant changes in vital signs, Laboratory test abnormalities, Clinically tolerability of the drug [ Time Frame: 12 and 24 Months ] [ Designated as safety issue: Yes ]
    AE = Adverse events


Estimated Enrollment: 600
Study Start Date: April 2013
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Belatacept
Belatacept 5 mg/kg intravenous 30 minute infusion on Days 1, 15, 29, 43, 57 then every 28 days for 24 months
Drug: Belatacept
Other Names:
  • BMS 224818
  • Nulojix®
Active Comparator: CNI

Tacrolimus 5-10 ng/mL tablet orally according to package insert for 24 months

Cyclosporine 100-250 ng/mL tablet orally according to package insert for 24 months

Drug: Tacrolimus Drug: Cyclosporine

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women, ages 18-75 inclusive
  • Adult recipients of a renal allograft from a living donor or a deceased donor between 6-36 months prior to enrollment
  • Receiving a stable (≥1 month) regimen of Calcineurin inhibitor (CNI) [Cyclosporine A (CsA) or Tacrolimus (TAC)] with Mycophenolate mofetil (MMF) or Enteric Coated Mycophenolate Sodium (EC-MPS)/Mycophenolic acid (MPA), and corticosteroids
  • Calculated glomerular filtration rate (cGFR) ≥30 and ≤75 mL/min/1.73 m2 [Modification of Diet in Renal Disease study (MDRD) 6 variable formula]

Exclusion Criteria:

  • Recipients with Epstein-Barr virus (EBV) serostatus negative or unknown
  • History of acute rejection (AR) within 3 months prior to randomization
  • History of antibody mediated rejection
  • Positive T-cell lymphocytotoxic cross match
  • Proteinuria >1 g/day or >0.5 g/day if diabetic
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01820572

Contacts
Contact: For participation information at a USA site use a phone number below. For Site information outside USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial site that are recruiting have contact information at this time

  Show 77 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01820572     History of Changes
Other Study ID Numbers: IM103-116, 2012-001314-42
Study First Received: March 14, 2013
Last Updated: September 17, 2013
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Tacrolimus
Abatacept
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 14, 2014