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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 October 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01820572
First received: March 14, 2013
Last updated: November 20, 2014
Last verified: October 2014
  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
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: March 2013
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: October 2018 (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

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
University Of Alabama At Birmingham (Uab) Recruiting
Birmingham, Alabama, United States, 35294
Contact: Roslyn Mannon, Site 0071    205-934-7220      
United States, California
Loma Linda University Medical Center-Transplantation Institu Recruiting
Loma Linda, California, United States, 92354
Contact: Arputharaj Kore, Site 0068    909-558-3670      
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Rafael Villicana, Site 0091    310-248-6528      
Keck Medical Center Of Usc, Hcc 1 Recruiting
Los Angeles, California, United States, 90033
Contact: Yasir Qazi, Site 0080    323-442-5322      
Transplant Research Institute Recruiting
Los Angeles, California, United States, 90057
Contact: Tariq Shah, Site 0077    213-384-4874      
University Of California - Los Angeles Recruiting
Los Angeles, California, United States, 90024
Contact: Suphamai Bunnapradist, Site 0090    310-794-8516      
University Of California Davis Health System Recruiting
Sacramento, California, United States, 95817
Contact: Deborah Adey, Site 0086    530-908-6778      
California Institute Of Renal Research Recruiting
San Diego, California, United States, 92123
Contact: Steven Marc Steinberg, Site 0001    858-637-4600      
University Of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Flavio Vincenti, Site 0096    415-353-8380      
California Pacific Medical Center Recruiting
San Francisco, California, United States, 94115
Contact: Venkat Peddi, Site 0023    415-600-1744      
United States, Colorado
University Of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Alexander Wiseman, Site 0087    303-724-0396      
Denver Nephrologists Recruiting
Denver, Colorado, United States, 80218
Contact: Bradley A Marder, Site 0003    303-861-4845      
United States, Connecticut
Yale University School Of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Contact: Sanjay Kulkarni, Site 0015    203-785-7031      
United States, Florida
Florida Hospital Recruiting
Orlando, Florida, United States, 32804
Contact: Bobby Nibhanupudy, Site 0027    407-303-2988      
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Victor Bowers, Site 0017    813-844-5692      
United States, Georgia
Emory Transplant Center Recruiting
Atlanta, Georgia, United States, 30322
Contact: Stephen Pastan, Site 0010    404-712-1816      
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Stephen C Jensik, Site 0089    312-942-3993      
United States, Iowa
University Of Iowa Health Care Recruiting
Iowa City, Iowa, United States, 52242
Contact: Daniel Katz, Site 0095    319-356-0578      
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, Jr, Site 0006    617-724-1270      
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Mariella Ortigosa-Goggins, 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, Missouri
Local Institution Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: Site 0076         
United States, New Jersey
Saint Barnabas Medical Center Recruiting
Livingston, New Jersey, United States, 07039
Contact: Anup Patel, Site 0084    973-322-5142      
United States, New York
Erie County Medical Center Recruiting
Buffalo, New York, United States, 14215
Contact: Mark Laftavi, Site 0078    716-898-3418      
Recanati/Miller Transplantation Institute Recruiting
New York, New York, United States, 10029
Contact: Sander Florman, Site 0002    212-659-8046      
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Paul F Gores, Site 0022    704-355-6359      
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Debra Sudan, Site 0007    919-681-6898      
East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Contact: Paul Bolin, Site 0009    252-744-3773      
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Richard Fatica, Site 0020    216-444-3256      
United States, Pennsylvania
Central Pa Transplant Foundation, Inc. Recruiting
Harrisburg, Pennsylvania, United States, 17104
Contact: Harold Yang, Site 0088    717-231-8700      
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    215-615-0773      
Upmc Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Sundaram Hariharan, Site 0025    412-864-3781      
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Reginald Gohh, Site 0079    401-444-8598      
United States, South Carolina
Medical University Of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Titte Srinivas, 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    615-936-1182      
United States, Texas
Annette C And Harold C Simmons Transplant Institute Recruiting
Dallas, Texas, United States, 75246
Contact: Kim Rice, Site 0083    214-820-1771      
Baylor All Saints Medical Centers Recruiting
Fort Worth, Texas, United States, 76104
Contact: Bernard Fischbach, Site 0094    817-922-7667      
Baylor College Of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Abbas Rana, Site 0098    832-355-1450      
The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Richard Knight, Site 0075    713-441-6396      
United States, Utah
University Of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Faud Shihab, Site 0069    801-585-3845      
United States, Virginia
University Of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Avinash Agarwal, Site 0011    434-982-3665      
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Contact: Thomas Mccune, Site 0013    757-388-5480      
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 Recruiting
Spokane, Washington, United States, 99204
Contact: Richard W Carson, Site 0021    509-474-3821      
United States, Wisconsin
University Of Wisconsin School Of Medicine & Public Health Recruiting
Madison, Wisconsin, United States, 53705
Contact: Arjang Djamali, Site 0097    608-262-7115      
Medical College Of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Brahm Vasudev, Site 0004    414-805-0752      
Argentina
Local Institution Not yet recruiting
Capital Federal, Buenos Aires, Argentina, 1155
Contact: Site 0055         
Local Institution Recruiting
Capital Federal, Buenos Aires, Argentina, C1425 ASS
Contact: Site 0057         
Local Institution Recruiting
Ciudad Autonoma, Buenos Aires, Argentina, 1118
Contact: Site 0093         
Local Institution Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1425
Contact: Site 0053         
Local Institution Recruiting
Rosario, Santa Fe, Argentina, 2000
Contact: Site 0060         
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 Recruiting
Graz, Austria, 8036
Contact: Site 0054         
Local Institution Recruiting
Innsbruck, Austria, 6020
Contact: Site 0047         
Local Institution Recruiting
Linz, Austria, 4020
Contact: Site 0052         
Local Institution Recruiting
Vienna, Austria, 1070
Contact: Site 0061         
Colombia
Local Institution Recruiting
Bogota, Cundinamarca, Colombia, -----
Contact: Site 0050         
Local Institution Recruiting
Cali, Valle del Cauca, Colombia, -----
Contact: Site 0048         
Germany
Local Institution Not yet recruiting
Berlin, Germany, 12203
Contact: Site 0067         
Local Institution Recruiting
Berlin, Germany, 10117
Contact: Site 0041         
Local Institution Recruiting
Dresden, Germany, 01307
Contact: Site 0040         
Local Institution Recruiting
Erlangen, Germany, 91054
Contact: Site 0065         
Local Institution Recruiting
Essen, Germany, 45147
Contact: Site 0066         
Local Institution Recruiting
Frankfurt, Germany, 60590
Contact: Site 0037         
Local Institution Recruiting
Hamburg, Germany, 20246
Contact: Site 0062         
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 Recruiting
Luebeck, Germany, 23538
Contact: Site 0051         
Local Institution Recruiting
Mannheim, Germany, 68167
Contact: Site 0043         
Local Institution Not yet recruiting
Muenster, Germany, 48147
Contact: Site 0059         
Local Institution Not yet recruiting
Regensburg, Germany, 93053
Contact: Site 0029         
Local Institution Recruiting
Wurzburg, Germany, 97080
Contact: Site 0045         
Netherlands
Local Institution Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: Site 0030         
Local Institution Recruiting
Groningen, Netherlands, 9713 GZ
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 Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Site 0064         
Norway
Local Institution Recruiting
Oslo, Norway, 0372
Contact: Site 0039         
Sweden
Local Institution Recruiting
Goteborg, Sweden, 41345
Contact: Site 0049         
Local Institution Recruiting
Stockholm, Sweden, 14186
Contact: Site 0063         
Local Institution Recruiting
Uppsala, Sweden, 75185
Contact: Site 0028         
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
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: November 20, 2014
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:
Cyclosporine
Cyclosporins
Tacrolimus
Anti-Infective Agents
Antifungal Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014