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

December 8, 2020 updated by: Bristol-Myers Squibb

Evaluation of the Benefits and Risks in Maintenance Renal Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based Immunosuppression

The primary purpose is to assess the benefits and risks of changing from Cyclosporine or Tacrolimus to Belatacept between 6-60 months after kidney transplant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

446

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1155
        • Local Institution
      • Caba, Argentina, 1425
        • Local Institution
      • Cordoba, Argentina, X5016KEH
        • Local Institution
      • Santa Fe, Argentina, 3000
        • Local Institution
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1093
        • Local Institution
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1425
        • Local Institution
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1118AAT
        • Local Institution
      • Mendoza, Buenos Aires, Argentina, M5501ACJ
        • Local Institution
    • Cordoba
      • Cardoba, Cordoba, Argentina, 5016
        • Local Institution
    • Santa FE
      • Rosario, Santa FE, Argentina, Santa Fe, 2000
        • Local Institution
  • Austria
      • Feldkirch, Austria, 6800
        • Local Institution
      • Graz, Austria, 8036
        • Local Institution
      • Innsbruck, Austria, 6020
        • Local Institution
      • Linz, Austria, 4020
        • Local Institution
      • Wien, Austria, 1090
        • Local Institution
  • Colombia
      • Bogota, Colombia
        • Local Institution
    • Valle DEL Cauca
      • Cali, Valle DEL Cauca, Colombia
        • Local Institution
  • France
      • Bois-Guillaume, France, 76230
        • Local Institution
      • Bordeaux, France, 33076
        • Local Institution
      • Brest Cedex 2, France, 29609
        • Local Institution
      • Creteil, France, 94010
        • Local Institution
      • GRENOBLE Cedex 09, France
        • Local Institution
      • Le Kremilin Bicretre, France, 942875
        • Local Institution
      • Lyon Cedex 03, France, 69437
        • Local Institution
      • Paris Cedex 10, France, 75475
        • Local Institution
      • Strasbourg Cedex, France, 67091
        • Local Institution
      • Toulouse Cedex 8, France, 31059
        • CHU Rangueil
    • Cedex 15
      • Paris, Cedex 15, France
        • Local Institution
  • Germany
      • Berlin, Germany, 10117
        • Local Institution
      • Dresden, Germany, 01307
        • Local Institution
      • Erlangen, Germany, 91054
        • Local Institution
      • Essen, Germany, 45147
        • Local Institution
      • Frankfurt am Main, Germany
        • Local Institution
      • Hamburg, Germany, 20246
        • Local Institution
      • Hannover, Germany, 30625
        • Local Institution
      • Heidelberg, Germany, 69120
        • Local Institution
      • Kiel, Germany, 24105
        • Local Institution
      • Lubeck, Germany, 23538
        • Local Institution
      • Mannheim, Germany, 68167
        • Local Institution
      • Muenchen, Germany, 81675
        • Local Institution
      • Munster, Germany, 48149
        • Local Institution
      • Regensburg, Germany, 93053
        • Local Institution
      • Wurzburg, Germany, 97080
        • Local Institution
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Local Institution
      • Amsterdam, Netherlands, 1081HV
        • Local Institution
      • Groningen, Netherlands, 9700RB
        • Local Institution
      • Leiden, Netherlands, 2333 ZA
        • Local Institution
      • Nijmegen, Netherlands, 6525 GA
        • Local Institution
      • Utrecht, Netherlands, 3584 CX
        • Local Institution
  • Norway
      • Oslo, Norway, 04224
        • Local Institution
      • Toensberg Norge, Norway, 3103
        • Local Institution
  • Sweden
      • Goteborg, Sweden, S-41345
        • Local Institution
      • Stockholm, Sweden, 14186
        • Local Institution
      • Uppsala, Sweden, 75185
        • Local Institution
  • Switzerland
      • Bern, Switzerland, 3010
        • Local Institution
      • Geneve 14, Switzerland, 1211
        • Local Institution
      • Zurich, Switzerland, 8091
        • Local Institution
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • UAB Division of Nephrology
    • Arizona
      • Phoenix, Arizona, United States, 85027
        • Mayo Clinic Hospital
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center (LLUMC) - Children's Hospital - Transplantation Institute
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90024
        • UCLA Kidney Transplant Research Office
      • Los Angeles, California, United States, 90033
        • Keck Medical Center of USC (PI Address)
      • Los Angeles, California, United States, 90057
        • Transplant Research Institute (PI Address)
      • Sacramento, California, United States, 95817
        • University of California, San Francisco (UCSF)-Kidney Transplant Service
      • San Diego, California, United States, 92123
        • California Institute of Renal Research
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center, Depart of Transplantation (PI Address)
      • San Francisco, California, United States, 94143-0116
        • UCSF Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver (PI Address)
      • Denver, Colorado, United States, 80218
        • Denver Nephrologists, PC
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale Medical Group
    • Florida
      • Orlando, Florida, United States, 32804
        • Florida Hospital Transplant Institute (PI Address)
      • Saint Petersburg, Florida, United States, 33716
        • Central Pharmacy
      • Tampa, Florida, United States, 33606
        • Tampa General Medicine Group
    • Georgia
      • Atlanta, Georgia, United States
        • Emory University
      • Augusta, Georgia, United States, 30912
        • Medical College of Georgia at Augusta University
    • Illinois
      • Chicago, Illinois, United States, 60612
        • RUSH University Transplant Program (PI Address)
      • Chicago, Illinois, United States
        • University of Wisconsin School of Medicine and Public Health (PI Address)
    • Iowa
      • Iowa City, Iowa, United States, 52242-1101
        • University of Iowa Health Care (PI Address)
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Health Sciences Center
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Transplant Program
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford's Transplant Institute
      • Roseville, Michigan, United States, 48066
        • St. Clair Nephrology Research
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington Univ School of Med
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University or Nebraska Medical Center
    • New Jersey
      • Livingston, New Jersey, United States, 07006
        • Saint Barnabas Medical Center
    • New York
      • Buffalo, New York, United States, 14215
        • University of Buffalo
      • New York, New York, United States, 10029
        • Recanati/Miller Transplantation Institue (PI Address)
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center (PI Address)
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Greenville, North Carolina, United States, 27834
        • East Carolina Univ Nephrology Clin Res. Lab
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44106-5055
        • University Hospitals Cleveland Medical Center
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17104
        • Central PA Transplant Foundation
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University College of Medicine
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Medicine
      • Pittsburgh, Pennsylvania, United States, 15213-2582
        • University of Pittsburgh Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina, SCTR Research Nexus
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Methodist University Hospital Transplant Institute (PI Address)
      • Nashville, Tennessee, United States, 37212-1375
        • Vanderbilt University Medical Center- GI Research Office
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
      • Fort Worth, Texas, United States, 76104
        • Baylor All Saints Medical Center at Ft. Worth
      • Houston, Texas, United States, 77030
        • The Methodist Hospital
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • Memorial Hermann - Texas Medical Center (Tmc), The University Of Texas Medical School At Houston
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Depart of Nephrology (PI Address)
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Health System (PI Address)
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital
      • Richmond, Virginia, United States, 23298-0160
        • Virginia Commonwealth University Medical Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center-Swedish Organ Transplant and Liver Center
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center (PI Address & Study Supplies Address)
      • Spokane, Washington, United States, 99204
        • Providence Sacred Heart Medical Center and Childrens Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of WI Froedtert Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Men and women, ages 18-75 inclusive
  • Adult recipients of a renal allograft from a living donor or a deceased donor between 6-60 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
  • Stable renal function for 12 weeks prior to enrollment without new onset proteinuria
  • Calculated glomerular filtration rate (cGFR) ≥30 and ≤75 mL/min/1.73 m2 [Modification of Diet in Renal Disease study (MDRD) 4-formula]

Exclusion Criteria:

  • Recipients with Epstein-Barr virus (EBV) serostatus negative or unknown
  • History of acute rejection (AR) within 3 months prior to enrollment
  • History of antibody mediated rejection
  • Positive T-cell lymphocytotoxic cross match
  • Proteinuria >1 g/day or >0.5 g/day if diabetic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Nulojix®
  • BMS 224818
Active Comparator: CNI

Tacrolimus 4-11 ng/mL tablet orally according to package insert for 24 months

Cyclosporine 50-250 ng/mL tablet orally according to package insert for 24 months
Drug: Tacrolimus
Drug: Cyclosporine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Survive With a Functional Graft at 24 Months
Time Frame: at 24 Months
Percentage of participants who survive with a functional graft at 24 months post-randomization
at 24 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Survive With a Functional Graft at 12 Months
Time Frame: at 12 Months
Percentage of participants who survive with a functional graft at 12 months post-randomization
at 12 Months
Number of Participants With a Biopsy Proven Acute Rejection (BPAR)
Time Frame: at 12 and 24 Months

The number of clinically suspected, biopsy proven acute rejection (AR) at 12 and 24 months post-randomization

includes participants with at least one cellular and/or humoral BPAR event.
at 12 and 24 Months
Number of Participants With Varying Severity of BPAR
Time Frame: at 12 and 24 months
Number of participants in each severity of clinically suspected, biopsy proven acute rejection (AR) at 12 and 24 months post-randomization
at 12 and 24 months
Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Percent Change
Time Frame: at 12 and 24 months
Mean change from baseline cGFR as calculated by the 4-variable MDRD equation to 12 and 24 months post-randomization - Percent Change
at 12 and 24 months
Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Adjusted Change
Time Frame: at 12 and 24 months
Mean change from baseline cGFR as calculated by the 4-variable MDRD equation to 12 and 24 months post-randomization - Adjusted Change
at 12 and 24 months
Mean Calculated Glomerular Filtration Rate (cGFR)
Time Frame: up to 24 months
Mean cGFR by study visit, as calculated by the 4-variable MDRD equation.
up to 24 months
Slope Analysis of cGFR
Time Frame: at 12 and 24 Months
Slopes of cGFR as plotted from baseline as well as from Month 3, to Month 12 and Month 24 post-randomization
at 12 and 24 Months
Slope Analysis of 1/Serum Creatinine
Time Frame: at 12 and 24 Months
Slopes of 1/serum creatinine as plotted from baseline as well as from Month 3, to Month 12 and Month 24 post-randomization
at 12 and 24 Months
Percentage of Participants With > 5% and >10% Improvement Over Baseline cGFR
Time Frame: at 12 and 24 Months
Percentage of participants with > 5% and >10% improvement over baseline cGFR, at 12 and 24 months post-randomization
at 12 and 24 Months
Mean Urine Protein/ Creatinine Ratio (UPCR)
Time Frame: Up to 24 Months
Urine protein/ creatinine ratio (UPCR) at baseline, 3, 6, 12 and 24 months post randomization
Up to 24 Months
Mean Change From Baseline in Systolic and Diastolic Blood Pressure
Time Frame: at 12 and 24 months
Mean change in systolic and diastolic blood pressure from baseline to 12 and 24 months post randomization
at 12 and 24 months
Number of Antihypertensive Medications Used to Control Hypertension
Time Frame: at baseline, 12 and 24 Months
The total number of antihypertensive medications used to control hypertension
at baseline, 12 and 24 Months
Number of Participants With Donor Specific Antibodies (DSA)
Time Frame: at baseline, 12 and 24 months
Number of participants with donor specific antibodies (DSA) at Baseline/Day 1, and Months 12 and 24 post-randomization
at baseline, 12 and 24 months
Mean Number of Symptom Occurrence and Symptom Distress
Time Frame: up to 12 Months

The frequency of symptom occurrence and symptom distress as measured with the Modified Transplant Symptom Occurrence and Symptom Distress Scale-59R (MTSOSD-59R) at baseline, Week 6, and Months 3, 6, and 12 post-randomization.

Higher scores in the MTSOSD-59R indicate a greater symptom and symptom distress burden than lower scores.
up to 12 Months
Number of Participants With an Adverse Event of Special Interest
Time Frame: 24 Months

Number of participants with an adverse event of special interests. Adverse events of special interest include:

Serious Infections, Post-Transplant Lymphoproliferative Disorder (PTLD), Progressive multifocal leukoencephalopathy (PML), Malignancies (other than PTLD) including non-melanoma skin carcinomas, Tuberculosis Infections, CNS infections, Viral Infections and Infusion related reactions.
24 Months
Number of Participants With Marked Laboratory Abnormalities
Time Frame: 24 Months
Number of participants with Marked Laboratory Abnormalities
24 Months
Mean Change From Baseline in Vital Signs: Heart Rate
Time Frame: at 12 and 24 months
The mean change from baseline in measured heart rate
at 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2013

Primary Completion (Actual)

October 24, 2019

Study Completion (Actual)

October 24, 2019

Study Registration Dates

First Submitted

March 14, 2013

First Submitted That Met QC Criteria

March 27, 2013

First Posted (Estimate)

March 29, 2013

Study Record Updates

Last Update Posted (Actual)

January 5, 2021

Last Update Submitted That Met QC Criteria

December 8, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM103-116
  • 2012-001314-42 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe