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

  Hide Study Locations
Locations
United States, Alabama
Local Institution Not yet recruiting
Birmingham, Alabama, United States, 35294
Contact: Site 0071         
United States, California
Local Institution Not yet recruiting
Loma Linda, California, United States, 92354
Contact: Site 0068         
Local Institution Not yet recruiting
Los Angeles, California, United States, 90057
Contact: Site 0077         
California Institute Of Renal Research Recruiting
San Diego, California, United States, 92123
Contact: Steven Marc Steinberg, Site 0001    858-499-1945      
Local Institution Not yet recruiting
San Francisco, California, United States, 94115
Contact: Site 0023         
United States, Colorado
Denver Nephrology, Pc Recruiting
Denver, Colorado, United States, 80218
Contact: Bradley A Marder, Site 0003    303-861-4845      
United States, Connecticut
Local Institution Not yet recruiting
New Haven, Connecticut, United States, 06520
Contact: Site 0015         
United States, Florida
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Orlando, Florida, United States, 32804
Contact: Site 0027         
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Tampa, Florida, United States, 33606
Contact: Site 0017         
United States, Georgia
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Atlanta, Georgia, United States, 30322
Contact: Site 0010         
United States, Massachusetts
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Boston, Massachusetts, United States, 02115
Contact: Site 0024         
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Boston, Massachusetts, United States, 02214
Contact: Site 0006         
United States, Michigan
Local Institution Not yet recruiting
Detroit, Michigan, United States, 48202
Contact: Site 0014         
Renaissance Renal Research Institute, LLC Recruiting
Detroit, Michigan, United States, 48236
Contact: David Butcher, Site 0012    313-886-8787      
United States, Missouri
Local institution Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: Site 0076         
United States, New York
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Buffalo, New York, United States, 14215
Contact: Site 0078         
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New York, New York, United States, 10029
Contact: Site 0002         
United States, North Carolina
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Charlotte, North Carolina, United States, 28203
Contact: Site 0022         
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Durham, North Carolina, United States, 27710
Contact: Site 0007         
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Greenville, North Carolina, United States, 27834
Contact: Site 0009         
United States, Ohio
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Cleveland, Ohio, United States, 44106
Contact: Site 0018         
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Cleveland, Ohio, United States, 44195
Contact: Site 0020         
United States, Oregon
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Portland, Oregon, United States, 04102
Contact: Site 0016         
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
Contact: Site 0005         
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Pittsburgh, Pennsylvania, United States, 15213-2582
Contact: Site 0025         
United States, Rhode Island
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Providence, Rhode Island, United States, 02903
Contact: Stie 0079         
United States, South Carolina
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Charleston, South Carolina, United States, 29425
Contact: Site 0026         
United States, Tennessee
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Memphis, Tennessee, United States, 38104
Contact: Site 0073         
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Nashville, Tennessee, United States, 37232-1371
Contact: Site 0074         
United States, Texas
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Houston, Texas, United States, 77030
Contact: Site 0075         
United States, Utah
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Salt Lake City, Utah, United States, 84132
Contact: Site 0069         
United States, Virginia
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Charlottesville, Virginia, United States, 22908
Contact: Site 0011         
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Norfolk, Virginia, United States, 23507
Contact: Site 0013         
United States, Washington
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Seattle, Washington, United States, 98195
Contact: Site 0019         
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Spokane, Washington, United States, 99204
Contact: Site 0021         
United States, Wisconsin
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Milwaukee, Wisconsin, United States, 53226
Contact: Site 0004         
Argentina
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Capital Federal, Buenos Aires, Argentina, 1155
Contact: Site 0055         
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1425
Contact: Site 0053         
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Rosario, Santa Fe, Argentina, 2000
Contact: Site 0060         
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Buenos Aires, Argentina, C1425 ASS
Contact: Site 0057         
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Cordoba, Argentina, X5016LIG
Contact: Site 0046         
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Santa Fe, Argentina, S3000EPV
Contact: Site 0070         
Austria
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Feldkirch, Austria, 6800
Contact: Site 0044         
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Graz, Austria, 8036
Contact: Site 0054         
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Innsbruck, Austria, 6020
Contact: Site 0047         
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Linz, Austria, 4020
Contact: Site 0052         
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Vienna, Austria, 1070
Contact: Site 0061         
Colombia
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Bogota, Cundinamarca, Colombia
Contact: Site 0050         
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Cali, Valle del Cauca, Colombia
Contact: Site 0048         
Germany
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Berlin, Germany, 10117
Contact: Site 0041         
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Berlin, Germany, 12203
Contact: Site 0067         
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Dresden, Germany, 01307
Contact: Site 0040         
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Erlangen, Germany, 91054
Contact: Site 0065         
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Essen, Germany, 45147
Contact: Site 0066         
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Frankfurt, Germany, 60590
Contact: Site 0037         
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Hamburg, Germany, 20246
Contact: Site 0062         
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Hannover, Germany, 30625
Contact: Site 0035         
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Heidelberg, Germany, 69120
Contact: Site 0050         
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Kiel, Germany, 24105
Contact: Site 0033         
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Luebeck, Germany, 23538
Contact: Site 0051         
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Mannheim, Germany, 68167
Contact: Site 0043         
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Muenster, Germany, 48147
Contact: Site 0059         
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Regensburg, Germany, 93053
Contact: Site 0029         
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Wuerzburg, Germany, 97080
Contact: Site 0045         
Netherlands
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Amsterdam, Netherlands, 1105
Contact: Site 0030         
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Groningen, Netherlands, 9700
Contact: Site 0056         
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Leiden, Netherlands, 2333
Contact: Site 0031         
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Nijmegen, Netherlands, Netherlands
Contact: Site 0038         
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Utrecht, Netherlands, 3584 CX
Contact: Site 0064         
Norway
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Oslo, Norway, 0027
Contact: Site 0039         
Sweden
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Goteborg, Sweden, 41345
Contact: Site 0049         
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Huddinge, Sweden, 141 86
Contact: Site 0063         
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Uppsala, Sweden, 751 85
Contact: Site 0028         
Switzerland
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Bern, Switzerland, 3010
Contact: Site 0042         
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Geneve 14, Switzerland, 1211
Contact: Site 0034         
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Lausanne, Switzerland, 1011
Contact: Site 0036         
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Zurich, Switzerland, 8006
Contact: Site 0032         
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 17, 2014