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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Kidney Transplantation	Drug: Belatacept; Drug: Tacrolimus; Drug: Cyclosporine	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	440 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Actual Study Start Date :	March 27, 2013
Estimated Primary Completion Date :	January 9, 2020
Estimated Study Completion Date :	January 10, 2020

Arms and Interventions

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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: BMS 224818; Nulojix®
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

Outcome Measures

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Primary Outcome Measures :

1. Proportion of subjects who survive with a functional graft at 24 months post randomization [ Time Frame: 24 months ]

Secondary Outcome Measures :

1. Patient and Graft Survival - Proportion of subjects who survive with a functional graft at 12 months post-randomization [ Time Frame: 12 month ]
2. Incidence of acute rejection (AR) post-randomization [ Time Frame: 12 and 24 months ]
3. Severity of AR post-randomization [ Time Frame: 12 and 24 months ]
4. 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 ]
5. 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 ]
6. 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 ]
7. 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 ]
8. 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 ]
9. Donor Specific Antibodies (DSA) - Proportion of donor specific antibodies (DSA) at 12 and 24 months post-randomization [ Time Frame: 12 and 24 Months ]
10. 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 ]
11. 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 ]
    AE = Adverse events

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

United States, Alabama
UAB Division of Nephrology
Birmingham, Alabama, United States, 352940006
United States, Arizona
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85027
United States, California
Loma Linda University Medical Center (LLUMC) - Children's Hospital - Transplantation Institute
Loma Linda, California, United States, 92354
Keck Medical Center of USC (PI Address)
Los Angeles, California, United States, 90033
Cedars-Sinai Medical Center-Kidney and Pancreas Transplant Center
Los Angeles, California, United States, 90048
Transplant Research Institute (PI Address)
Los Angeles, California, United States, 90057
UCLA Kidney Transplant Research Office
Los Angeles, California, United States, 90095-6984
University of California, San Francisco (UCSF)-Kidney Transplant Service
Sacramento, California, United States, 95817
California Institute Of Renal Research
San Diego, California, United States, 92123
California Pacific Medical Center, Depart of Transplantation (PI Address)
San Francisco, California, United States, 94115
UCSF Medical Center
San Francisco, California, United States, 94143
United States, Colorado
University of Colorado Denver (PI Address)
Aurora, Colorado, United States, 80045
Denver Nephrologists, PC
Denver, Colorado, United States, 80218
United States, Connecticut
Yale University School of Medicine (Study Supplies Address)
New Haven, Connecticut, United States, 06511
United States, Florida
Florida Hospital Transplant Institute (PI Address)
Orlando, Florida, United States, 32804
Local Institution
Saint Petersburg, Florida, United States, 33716
Tampa General Medicine Group
Tampa, Florida, United States, 33606
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Vanderbilt University Medical Center
Atlanta, Georgia, United States, 31192
Medical College of Georgia at Augusta University
Augusta, Georgia, United States, 30912
United States, Illinois
RUSH University Transplant Program (PI Address)
Chicago, Illinois, United States, 60612
United States, Iowa
University of Iowa Health Care (PI Address)
Iowa City, Iowa, United States, 52240
United States, Louisiana
Tulane University Health Sciences Center, Cancer Center
New Orleans, Louisiana, United States, 70112
United States, Maine
Maine Transplant Program
Portland, Maine, United States, 04102
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Henry Ford's Transplant Institute
Detroit, Michigan, United States, 48202
Renaissance Renal Research Institute, LLC (PI, SC, and Drug Ship Address)
Detroit, Michigan, United States, 48236
United States, Minnesota
Local Institution
Rochester, Minnesota, United States, 55905
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington Univ School of Med
Saint Louis, Missouri, United States, 63110
United States, Nebraska
University or Nebraska Medical Center
Omaha, Nebraska, United States, 68105
United States, New Jersey
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07006
United States, New York
University of Buffalo
Buffalo, New York, United States, 14215
Recanati/Miller Transplantation Institue (PI Address)
New York, New York, United States, 10029
United States, North Carolina
Carolinas Medical Center (PI Address)
Charlotte, North Carolina, United States, 28203
Duke University Medical Center
Durham, North Carolina, United States, 27710
East Carolina Univ Nephrology Clin Res. Lab
Greenville, North Carolina, United States, 27834
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106-5055
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Central PA Transplant Foundation
Harrisburg, Pennsylvania, United States, 17104
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
Penn Medicine
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15217
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina, SCTR Research Nexus
Charleston, South Carolina, United States, 29425
United States, Tennessee
Methodist University Hospital Transplant Institute (PI Address)
Memphis, Tennessee, United States, 38104
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390-9236
Baylor University Medical Center
Dallas, Texas, United States, 85246
Baylor All Saints Medical Center at Ft. Worth
Fort Worth, Texas, United States, 76104
Baylor College of Medicine
Houston, Texas, United States, 77030
Memorial Hermann - Texas Medical Center (Tmc), The University Of Texas Medical School At Houston
Houston, Texas, United States, 77030
The Methodist Hospital
Houston, Texas, United States, 77030
United States, Utah
University of Utah Depart of Nephrology (PI Address)
Salt Lake City, Utah, United States, 84112
United States, Virginia
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298
United States, Washington
CHU Rangueil
Seattle, Washington, United States, 98122
Swedish Medical Center - Swedish Organ Transplant and Liver Center
Seattle, Washington, United States, 98122
University of Washington Medical Center (PI Address & Study Supplies Address)
Seattle, Washington, United States, 98195
Providence Sacred Heart Medical Center and Childrens Hospital
Spokane, Washington, United States, 99204
United States, Wisconsin
University of Wisconsin School of Medicine and Public Health (PI Address)
Madison, Wisconsin, United States, 53792
Medical College of WI Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Argentina
Local Institution
Caba, Buenos Aires, Argentina, 1118
Local Institution
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1425
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La Plata, Buenos Aires, Argentina, 1900
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Ciudad De Mendoza, Mendoza, Argentina, 5501
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Rosario, Santa FE, Argentina, Santa Fe, 2000
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Buenos Aires, Argentina, 1093 AAS
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Buenos Aires, Argentina, 1155
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Buenos Aires, Argentina, C1425 ASS
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Cordoba, Argentina, 5016
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Santa Fe, Argentina, S3000EPV
Austria
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Feldkirch, Austria, 6800
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Graz, Austria, 8036
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Innsbruck, Austria, 6020
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Linz, Austria, 4020
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Wien, Austria, A-1070
Colombia
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Bogota, Colombia
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Cali, Colombia
France
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Bordeaux, France, 33076
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Brest, France, 29609
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Creteil, France, 94010
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La Tronche, France, 38700
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Le Kremlin-Bicetre, France, 94270
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Lyon, France, 69003
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Paris Cedex 10, France, 75475
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Paris, France, 75011
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Rouen, France, 76031
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Strasbourg, France, 67091
Germany
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Berlin, Germany, 10117
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Berlin, Germany, 12200
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Dresden, Germany, 01307
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Erlangen, Germany, 91054
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Essen, Germany, 45147
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Frankfurt / Main, Germany, 60590
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Hamburg, Germany, 20246
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Hannover, Germany, 30625
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Heidelberg, Germany, 69120
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Kiel, Germany, 24105
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Lubeck, Germany, 23538
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Mannheim, Germany, 68167
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Muenchen, Germany, 81675
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Muenster, Germany, 48147
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Regensburg, Germany, 93053
Local Institution
Wurzburg, Germany, 97080
Greece
University of Virginia Health System (PI Address)
Ioannina, Greece, 45500
Netherlands
Local Institution
Amsterdam, Netherlands, 1081HV
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Amsterdam, Netherlands, 1105 AZ
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Groningen, Netherlands, 9700RB
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Leiden, Netherlands, 2333 ZA
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Nijmegen, Netherlands, 6525 GA
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Utrecht, Netherlands, 3584 CX
Norway
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Oslo, Norway, 0027
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Toensberg Norge, Norway, 3103
Sweden
Local Institution
Goteborg, Sweden, S-41345
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Stockholm, Sweden, 14186
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Uppsala, Sweden, 75185
Switzerland
Local Institution
Bern, Switzerland, 3010
Local Institution
Geneve 14, Switzerland, 1211
Local Institution
Zürich, Switzerland, 8091

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

BMS Clinical Trial Information 

FDA Safety Alerts and Recalls 

BMS Clinical Trial Patient Recruiting 

Investigator Inquiry Form 

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT01820572 History of Changes
Other Study ID Numbers:	IM103-116; 2012-001314-42 ( EudraCT Number )
First Posted:	March 29, 2013
Last Update Posted:	February 27, 2018
Last Verified:	February 2018

Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:

Tacrolimus; Cyclosporins; Cyclosporine; Abatacept; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs	Calcineurin Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antifungal Agents; Anti-Infective Agents; Dermatologic Agents; Antirheumatic Agents