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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01820572
First received: March 14, 2013
Last updated: March 3, 2017
Last verified: June 2016
  Purpose
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 Intervention Phase
Kidney Transplantation
Drug: Belatacept
Drug: Tacrolimus
Drug: Cyclosporine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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 ]

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 ]
  • Incidence of acute rejection (AR) post-randomization [ Time Frame: 12 and 24 months ]
  • Severity of AR post-randomization [ Time Frame: 12 and 24 months ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Donor Specific Antibodies (DSA) - Proportion of donor specific antibodies (DSA) at 12 and 24 months post-randomization [ Time Frame: 12 and 24 Months ]
  • 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 ]
  • 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


Estimated Enrollment: 440
Study Start Date: March 2013
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (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 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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01820572

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Hide Study Locations
Locations
United States, Alabama
Uab Division Of Nephrology Recruiting
Birmingham, Alabama, United States, 352940006
Contact: Roslyn Mannon, Site 0071    205-996-9632      
Ucla Kidney Transplant Research Office Recruiting
Los Angeles, Alabama, United States, 90204
Contact: Suphamai Bunnapradist, Site 0090         
United States, Arizona
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
Contact: Hasan Khamash, Site 0112         
United States, California
Loma Linda University (Pi Address) Recruiting
Loma Linda, California, United States, 92354
Contact: Arputharaj Kore, Site 0068         
Keck Medical Center Of Usc (Pi Address) Recruiting
Los Angeles, California, United States, 90033
Contact: Yasir Qazi, Site 0080         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Stanley Jordan, Site 0091         
Transplant Research Institute Recruiting
Los Angeles, California, United States, 90057
Contact: Tariq Shah, Site 0077    213-384-4874      
Uc Davis Heart Center Recruiting
Sacramento, California, United States, 95817
Contact: Brian Gallay, Site 0086         
California Institute Of Renal Research Recruiting
San Diego, California, United States, 92123
Contact: Steven Marc Steinberg, Site 0001    858-637-4600      
California Pacific Medical Center Recruiting
San Francisco, California, United States, 94115
Contact: Venkat Peddi, Site 0023    415-600-1744      
Ucsf Medical Center Recruiting
San Francisco, California, United States, 94143
Contact: Flavio Vincenti, Site 0096         
United States, Colorado
University Of Colorado Denver (Pi Address) Recruiting
Aurora, Colorado, United States, 80045
Contact: Alexander Wiseman, Site 0087         
Denver Nephrologists, Pc Recruiting
Denver, Colorado, United States, 80218
Contact: Bradley Marder, Site 0003    303-861-4845      
United States, Connecticut
Yale University School Of Medicine (Study Supplies Address) Recruiting
New Haven, Connecticut, United States, 06520
Contact: Sanjay Kulkarni, Site 0015         
United States, Florida
Florida Hospital Transplant Institute (Pi Address) Recruiting
Orlando, Florida, United States, 32804
Contact: Bobby Nibhanupudy, Site 0027         
Tampa General Medicine Group Recruiting
Tampa, Florida, United States, 33606
Contact: Victor Bowers, Site 0017         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Stephan Pastan, Site 0010         
Medical College Of Georgia At Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Carlos Zayas-Montalvo, Site 0111    706-721-9546      
United States, Illinois
Rush University Transplant Program (Pi Address) Recruiting
Chicago, Illinois, United States, 60612
Contact: Stephen Jensik, Site 0089         
Pharmastart Recruiting
Northbrook, Illinois, United States, 60062
Contact: Ann Kruk, Site 0101    727-573-7847 ext 246      
United States, Iowa
University Of Iowa Health Care (Pi Address) Recruiting
Iowa City, Iowa, United States, 52240
Contact: Daniel Katz, Site 0095    319-467-5677      
United States, Louisiana
Tulane University Health Sciences Center, Cancer Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Rubin Zhang, Site 0115         
United States, Maine
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
Contact: John Vella, Site 0016    207-662-7191      
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Winfred Williams, Site 0006    617-724-1270      
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Rohini Prashar, Site 0014    313-916-4596      
Renaissance Renal Research Institute, Llc Recruiting
Detroit, Michigan, United States, 48236
Contact: David Butcher, Site 0012    313-886-8787      
United States, Minnesota
Local Institution Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Site 0114         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Mark Stegall, Site 0109         
United States, Missouri
Washington University School Of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Daniel Brennan, Site 0076    314-362-8351      
United States, Nebraska
University Or Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Clifford Miles, Site 0117         
United States, New Jersey
Saint Barnabas Medical Center Recruiting
Livingston, New Jersey, United States, 07039
Contact: Anup Patel, Site 0084    973-322-2142      
United States, New York
Erie County Medical Center Recruiting
Buffalo, New York, United States, 14215
Contact: Mareena Zachariah, Site 0078    716-898-3418      
Recanati/Miller Transplantation Institute Recruiting
New York, New York, United States, 10029
Contact: Sander Florman, Site 0002    504-988-8260      
United States, North Carolina
Carolinas Medical Center (Pi Address) Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Paul Gores, Site 0022         
Duke University Medical Center (Pi Address) Recruiting
Durham, North Carolina, United States, 27710
Contact: Debra Sudan, Site 0007    919-681-6898      
East Carolina Univ Nephrology Clin Res. Lab (Sc Address) Recruiting
Greenville, North Carolina, United States, 27834
Contact: Paul Bolin, Site 0009         
United States, Ohio
University Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Donald Hricik, Site 0106    216-844-5396      
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Richard Fatica, Site 0020         
United States, Pennsylvania
Central Pa Transplant Foundation (Pi And Sc Address) Recruiting
Harrisburg, Pennsylvania, United States, 17104
Contact: Harold Yang, Site 0088         
Drexel University College Of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Karthik Ranganna, Site 0085    267-507-6811      
Penn Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Roy Bloom, Site 0005         
University Of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15217
Contact: Sundaram Hariharan, Site 0025         
United States, Rhode Island
Rhode Island Hospital (Pi Address) Recruiting
Providence, Rhode Island, United States, RI 02903
Contact: Reginald Gohh, Site 0079         
United States, South Carolina
Medical University Of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Maria Salas, Site 0026    843-792-8824      
United States, Tennessee
Methodist University Hospital Recruiting
Memphis, Tennessee, United States, 38104
Contact: Luis Campos De La Borbolla, Site 0073    901-516-2031      
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: J. Harold Helderman, Site 0074    615-322-6976      
United States, Texas
Annette C And Harold C Simmons Transplant Institute Recruiting
Dallas, Texas, United States, 75246
Contact: Kim Rice, Site 0083    214-820-6624      
William P. Clements Jr University Hospital Recruiting
Dallas, Texas, United States, 75390
Contact: Malcolm Macconmara, Site 0113         
Baylor All Saints Medical Center At Ft. Worth Recruiting
Fort Worth, Texas, United States, 76014
Contact: Bernard Fischbach, Site 0094    817-922-2571      
Baylor College Of Medicine Completed
Houston, Texas, United States, 77030
The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Richard Knight, Site 0075    713-441-6396      
University Of Texas Health Science Center At Houston Recruiting
Houston, Texas, United States, 77030
Contact: John Bynon, Site 0108    713-704-4137      
Local Institution Not yet recruiting
San Antonio, Texas, United States, 78284
Contact: Site 0110         
United States, Utah
University Of Utah Depart Of Nephrology (Pi Address) Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Fuad Shihab, Site 0069         
United States, Virginia
University Of Virginia Health System (Pi Address) Recruiting
Charlotesville, Virginia, United States, 22908
Contact: Avinash Agarwal, Site 0011         
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Contact: Thomas Mccune, Site 0013    757-388-7511      
Virginia Commonwealth University Medical Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Gaurav Gupta, Site 0103    434-924-5125      
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Nelson Goes, Site 0082    206-215-3063      
University Of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Nicolae Leca, Site 0019    206-598-1562      
Providence Sacred Heart Medical Center And Childrens Hospital Recruiting
Spokane, Washington, United States, 99204
Contact: Samer Bani Hani, Site 0021    509-474-4302      
United States, Wisconsin
University Of Wisconsin School Of Medicine And Public Health (Pi Address) Recruiting
Madison, Wisconsin, United States, 53705
Contact: Arjang Djamali, Site 0097    608-262-1632      
Medical College Of Wi- Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Ehab Saad, Site 0004         
Argentina
Local Institution Recruiting
Capital Federal, Buenos Aires, Argentina, 1155
Contact: Site 0055         
Local Institution Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1425
Contact: Site 0053         
Local Institution Not yet recruiting
La Plata, Buenos Aires, Argentina
Contact: Site 0128         
Local Institution Recruiting
CB B rdoba, Cordoba, Argentina, 5016
Contact: Site 0104         
Local Institution Not yet recruiting
Ciudad De Mendoza, Mendoza, Argentina, 5501
Contact: Site 0107         
Local Institution Recruiting
Rosario, Santa Fe, Argentina, Santa Fe, 2000
Contact: Site 0060         
Local Institution Not yet recruiting
Buenos Aires, Argentina, 1093 AAS
Contact: Site 0131         
Local Institution Recruiting
Caba, Argentina, 1425
Contact: Site 0057         
Local Institution Recruiting
Caba, Argentina
Contact: Site 0093         
Local Institution Recruiting
Cordoba, Argentina, X5016LIG
Contact: Site 0046         
Local Institution Recruiting
Santa Fe, Argentina, S3000EPV
Contact: Site 0070         
Austria
Local Institution Recruiting
Feldkirch, Austria, 6800
Contact: Site 0044         
Local Institution Active, not recruiting
Graz, Austria, 8036
Local Institution Recruiting
Innsbruck, Austria, 6020
Contact: Site 0047         
Local Institution Recruiting
Linz, Austria, 4020
Contact: Site 0052         
Local Institution Recruiting
Wien, Austria, A-1070
Contact: Site 0061         
Colombia
Local Institution Recruiting
Bogota, Cundinamarca, Colombia
Contact: Site 0050         
France
Local Institution Recruiting
Bordeaux, France, 33000
Contact: Site 0121         
Local Institution Recruiting
Brest, France, 29609
Contact: Site 0127         
Local Institution Recruiting
Creteil, France, 94010
Contact: Site 0120         
Local Institution Recruiting
Grenoble Cedex 9, France, 38043
Contact: Site 0124         
Local Institution Recruiting
Le Kremlin Bicetre Cedex, France, 94275
Contact: Site 0122         
Local Institution Recruiting
Lyon, France, 69003
Contact: Site 0125         
Local Institution Recruiting
Paris, France, 75011
Contact: Site 0123         
Local Institution Recruiting
Paris, France, 75475
Contact: Site 0126         
Local Institution Recruiting
Rouen, France, 76031
Contact: Site 0130         
Local Institution Recruiting
Strasbourg, France, 67091
Contact: Site 0119         
Chu Rangueil Recruiting
Toulouse, France, 31400
Contact: Nassim Kamar, Site 0129         
Germany
Local Institution Recruiting
Berlin, Germany, 10117
Contact: Site 0041         
Local Institution Not yet recruiting
Berlin, Germany, 12200
Contact: Site 0067         
Local Institution Active, not recruiting
Dresden, Germany, 01307
Local Institution Recruiting
Erlangen, Germany, 91054
Contact: Site 0065         
Local Institution Recruiting
Essen, Germany, 45147
Contact: Site 0066         
Local Institution Recruiting
Frankfurt / Main, Germany, 60590
Contact: Site 0037         
Local Institution Active, not recruiting
Hamburg, Germany, 20246
Local Institution Recruiting
Hannover, Germany, 30625
Contact: Site 0035         
Local Institution Recruiting
Heidelberg, Germany, 69120
Contact: Site 0058         
Local Institution Recruiting
Kiel, Germany, 24105
Contact: Site 0033         
Local Institution Active, not recruiting
Luebeck, Germany, 23538
Local Institution Recruiting
Mannheim, Germany, 68167
Contact: Site 0043         
Local Institution Recruiting
Muenchen, Germany, 81675
Contact: Site 0099         
Local Institution Recruiting
Munster, Germany, 48149
Contact: Site 0059         
Local Institution Recruiting
Regensburg, Germany, 93053
Contact: Site 0029         
Local Institution Not yet recruiting
Ulm, Germany, 89081
Contact: Site 0116         
Local Institution Active, not recruiting
Wuerzburg, Germany, 97080
Netherlands
Local Institution Recruiting
Amsterdam, Netherlands, 1081HV
Contact: Site 0100         
Local Institution Active, not recruiting
Amsterdam, Netherlands, 1105 AZ
Local Institution Recruiting
Groningen, Netherlands, 9700RB
Contact: Site 0056         
Local Institution Recruiting
Leiden, Netherlands, 2333 ZA
Contact: Site 0031         
Local Institution Recruiting
Nijmegen, Netherlands, 6525 GA
Contact: Site 0038         
Local Institution Active, not recruiting
Utrecht, Netherlands, 3584 CX
Norway
Local Institution Recruiting
Toensberg, Vestfold, Norway, 3103
Contact: Site 0118         
Local Institution Recruiting
Oslo, Norway, 0027
Contact: Site 0039         
Sweden
Local Institution Recruiting
Goteborg, Sweden, 41345
Contact: Site 0049         
Local Institution Active, not recruiting
Stockholm, Sweden, 14186
Local Institution Active, not recruiting
Uppsala, Sweden, 75185
Switzerland
Local Institution Recruiting
Bern, Switzerland, 3010
Contact: Site 0042         
Local Institution Not yet recruiting
Geneve 14, Switzerland, 1211
Contact: Site 0034         
Local Institution Not yet recruiting
Lausanne, Switzerland, 1011
Contact: Site 0081         
Local Institution Not yet recruiting
ZB rich, Switzerland, 8091
Contact: Site 0032         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01820572     History of Changes
Other Study ID Numbers: IM103-116
2012-001314-42 ( EudraCT Number )
Study First Received: March 14, 2013
Last Updated: March 3, 2017

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

ClinicalTrials.gov processed this record on March 27, 2017