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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Transplantation

Intervention: Belatacept (Drug); Tacrolimus (Drug); Cyclosporine (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Overall contact:
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:, Email: Clinical.Trials@bms.com

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Proportion of subjects who survive with a functional graft at 24 months post randomization

Secondary outcome:

Patient and Graft Survival - Proportion of subjects who survive with a functional graft at 12 months post-randomization

Incidence of acute rejection (AR) post-randomization

Severity of AR post-randomization

Renal Function - Mean change in cGFR (MDRD) from baseline to 12 and 24 months post-randomization (% and absolute)

Renal Function - Slopes of cGFR and 1/serum creatinine respectively from baseline as well as Month 3 to 12 and 24 months post-randomization

Renal Function - Proportion of subjects with >5% and >10% improvement over baseline in cGFR at 12 and 24 months post-randomization

Renal Function - Urine protein/creatinine ratio (UPCR) at baseline, 3, 6, 12 and 24 months post-randomization

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

Donor Specific Antibodies (DSA) - Proportion of donor specific antibodies (DSA) at 12 and 24 months post-randomization

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

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

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:, Email: Clinical.Trials@bms.com

Local Institution, Caba 1425, Argentina; Recruiting
Site 0057

Local Institution, Caba, Argentina; Recruiting
Site 0093

Local Institution, Cordoba 5016, Argentina; Not yet recruiting
Site 0104

Local Institution, Cordoba X5016LIG, Argentina; Recruiting
Site 0046

Local Institution, Santa Fe S3000EPV, Argentina; Recruiting
Site 0070

Local Institution, Feldkirch 6800, Austria; Recruiting
Site 0044

Local Institution, Gaz 8036, Austria; Recruiting
Site 0054

Local Institution, Innsbruck 6020, Austria; Recruiting
Site 0047

Local Institution, Linz 4020, Austria; Recruiting
Site 0052

Local Institution, Wien 1090, Austria; Recruiting
Site 0061

Local Institution, Berlin 10117, Germany; Recruiting
Site 0041

Local Institution, Berlin 12203, Germany; Not yet recruiting
Site 0067

Local Institution, Dresden 01307, Germany; Recruiting
Site 0040

Local Institution, Erlangen 91054, Germany; Recruiting
Site 0065

Local Institution, Essen 45147, Germany; Recruiting
Site 0066

Local Institution, Frankfurt am Main 60590, Germany; Recruiting
Site 0037

Local Institution, Hamburg 20246, Germany; Recruiting
Site 0062

Local Institution, Hannover 30625, Germany; Recruiting
Site 0035

Local Institution, Heidelberg 69120, Germany; Recruiting
Site 0058

Local Institution, Kiel 24105, Germany; Recruiting
Site 0033

Local Institution, Lubeck 23538, Germany; Recruiting
Site 0051

Local Institution, Mannheim 68167, Germany; Recruiting
Site 0043

Local Institution, Muenchen 81675, Germany; Recruiting
Site 0099

Local Institution, Munster 48149, Germany; Recruiting
Site 0059

Local Institution, Regensburg 93053, Germany; Recruiting
Site 0029

Local Institution, Wurzburg 97080, Germany; Recruiting
Site 0045

Local Institution, Amsterdam 1105 AZ, Netherlands; Recruiting
Site 0030

Local Institution, Amsterdam 1081 HV, Netherlands; Recruiting
Site 0100

Local Institution, Groningen 9713 GZ, Netherlands; Recruiting
Site 0056

Local Institution, Leiden 2333 ZA, Netherlands; Recruiting
Site 0031

Local Institution, Nijmegen 6525 GA, Netherlands; Recruiting
Site 0038

Local Institution, Utrecht 3584 CX, Netherlands; Recruiting
Site 0064

Local Institution, Oslo 0372, Norway; Recruiting
Site 0039

Local Institution, Goteborg 41345, Sweden; Recruiting
Site 0049

Local Institution, Stockholm 14186, Sweden; Recruiting
Site 0063

Local Institution, Uppsala 75185, Sweden; Recruiting
Site 0028

Local Institution, Bern 3010, Switzerland; Recruiting
Site 0042

Local Institution, Geneve 14 1211, Switzerland; Not yet recruiting
Site 0034

Local Institution, Lausanne 1011, Switzerland; Not yet recruiting
Site 0081

Local Institution, Zurich 8006, Switzerland; Recruiting
Site 0032

University Of Alabama At Birmingham (Uab), Birmingham, Alabama 35294, United States; Recruiting
Roslyn Mannon, Site 0071, Phone: 205-934-7220

Local Institution, Phoenix, Arizona 85054, United States; Not yet recruiting
Site 0109

Local Institution, Capital Federal, Buenos Aires 1155, Argentina; Recruiting
Site 0055

Local Institution, Ciudad Autonoma de Buenos Aires, Buenos Aires 1425, Argentina; Recruiting
Site 0053

Loma Linda University Medical Center-Transplantation Institu, Loma Linda, California 92354, United States; Recruiting
Arputharaj Kore, Site 0068, Phone: 909-558-3670

Cedars Sinai Medical Center, Los Angeles, California 90048, United States; Recruiting
Rafael Villicana, Site 0091, Phone: 310-248-6528

Keck Medical Center Of Usc, Hcc 1, Los Angeles, California 90033, United States; Recruiting
Yasir Qazi, Site 0080, Phone: 323-442-5322

Transplant Research Institute, Los Angeles, California 90057, United States; Recruiting
Tariq Shah, Site 0077, Phone: 213-384-4874

University Of California - Los Angeles, Los Angeles, California 90024, United States; Recruiting
Suphamai Bunnapradist, Site 0090, Phone: 310-794-8516

University Of California Davis Health System, Sacramento, California 95817, United States; Recruiting
Brian Gallay, Site 0086, Phone: 530-908-6778

California Institute Of Renal Research, San Diego, California 92123, United States; Recruiting
Steven Marc Steinberg, Site 0001, Phone: 858-637-4600

California Pacific Medical Center, San Francisco, California 94115, United States; Recruiting
Venkat Peddi, Site 0023, Phone: 415-600-1744

University Of California San Francisco, San Francisco, California 94143, United States; Recruiting
Flavio Vincenti, Site 0096, Phone: 415-353-8380

University Of Colorado, Aurora, Colorado 80045, United States; Recruiting
Alexander Wiseman, Site 0087, Phone: 303-724-0396

Denver Nephrologists, Denver, Colorado 80218, United States; Recruiting
Bradley A Marder, Site 0003, Phone: 303-861-4845

Yale University School Of Medicine, New Haven, Connecticut 06520, United States; Recruiting
Sanjay Kulkarni, Site 0015, Phone: 203-785-7031

Local Institution, Bogota, Cundinamarca -----, Colombia; Recruiting
Site 0050

Florida Hospital, Orlando, Florida 32804, United States; Recruiting
Bobby Nibhanupudy, Site 0027, Phone: 407-303-2988

Tampa General Hospital, Tampa, Florida 33606, United States; Recruiting
Victor Bowers, Site 0017, Phone: 813-844-5692

Emory Transplant Center, Atlanta, Georgia 30322, United States; Recruiting
Stephen Pastan, Site 0010, Phone: 404-712-1816

Local Institution, Augusta, Georgia 30912, United States; Not yet recruiting
Site 0111

Rush University Medical Center, Chicago, Illinois 60612, United States; Recruiting
Stephen C Jensik, Site 0089, Phone: 312-942-3993

University Of Iowa Health Care, Iowa City, Iowa 52242, United States; Recruiting
Daniel Katz, Site 0095, Phone: 319-356-0578

Maine Medical Center, Portland, Maine 04102, United States; Recruiting
John Vella, Site 0016, Phone: 207-662-7191

Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Winfred Williams, Jr, Site 0006, Phone: 617-724-1270

Henry Ford Health System, Detroit, Michigan 48202, United States; Recruiting
Mariella Ortigosa-Goggins, Site 0014, Phone: 313-916-4596

Renaissance Renal Research Institute, Llc, Detroit, Michigan 48236, United States; Recruiting
David Butcher, Site 0012, Phone: 313-886-8787

Washington University School Of Medicine, Saint Louis, Missouri 63110, United States; Recruiting
Daniel Brennan, Site 0076, Phone: 314-362-8351

Saint Barnabas Medical Center, Livingston, New Jersey 07039, United States; Recruiting
Anup Patel, Site 0084, Phone: 973-322-5142

Erie County Medical Center, Buffalo, New York 14215, United States; Recruiting
Mark Laftavi, Site 0078, Phone: 716-898-3418

Recanati/Miller Transplantation Institute, New York, New York 10029, United States; Recruiting
Sander Florman, Site 0002, Phone: 212-659-8046

Carolinas Medical Center, Charlotte, North Carolina 28203, United States; Recruiting
Paul F Gores, Site 0022, Phone: 704-355-6359

Duke University Medical Center, Durham, North Carolina 27710, United States; Recruiting
Debra Sudan, Site 0007, Phone: 919-681-6898

East Carolina University, Greenville, North Carolina 27834, United States; Recruiting
Paul Bolin, Site 0009, Phone: 252-744-3773

Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States; Recruiting
Richard Fatica, Site 0020, Phone: 216-444-3256

Local Institution, Cleveland, Ohio 44106, United States; Not yet recruiting
Site 0106

Central Pa Transplant Foundation, Inc., Harrisburg, Pennsylvania 17104, United States; Recruiting
Harold Yang, Site 0088, Phone: 717-231-8700

Drexel University College Of Medicine, Philadelphia, Pennsylvania 19102, United States; Recruiting
Karthik Ranganna, Site 0085, Phone: 267-507-6811

Penn Medicine, Philadelphia, Pennsylvania 19104, United States; Recruiting
Roy Bloom, Site 0005, Phone: 215-615-0773

Upmc, Pittsburgh, Pennsylvania 15213, United States; Recruiting
Sundaram Hariharan, Site 0025, Phone: 412-864-3781

Rhode Island Hospital, Providence, Rhode Island 02903, United States; Recruiting
Reginald Gohh, Site 0079, Phone: 401-444-8598

Local Institution, Rosario, Santa Fe 2000, Argentina; Recruiting
Site 0060

Medical University Of South Carolina, Charleston, South Carolina 29425, United States; Recruiting
Titte Srinivas, Site 0026, Phone: 843-792-8824

Methodist University Hospital, Memphis, Tennessee 38104, United States; Recruiting
Luis Campos De La Borbolla, Site 0073, Phone: 901-516-2031

Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States; Recruiting
J. Harold Helderman, Site 0074, Phone: 615-322-6976

Annette C And Harold C Simmons Transplant Institute, Dallas, Texas 75246, United States; Recruiting
Kim Rice, Site 0083, Phone: 214-820-1771

Baylor All Saints Medical Centers, Fort Worth, Texas 76104, United States; Recruiting
Bernard Fischbach, Site 0094, Phone: 817-922-7667

Baylor Clinic, Houston, Texas 77030, United States; Recruiting
Abbas Rana, Site 0098, Phone: 832-355-1450

Local Institution, Houston, Texas 77074, United States; Not yet recruiting
Site 0108

The Methodist Hospital, Houston, Texas 77030, United States; Recruiting
Richard Knight, Site 0075, Phone: 713-441-6396

Local Institution, San Antonio, Texas 78284, United States; Not yet recruiting
Site 0110

University Of Utah, Salt Lake City, Utah 84132, United States; Recruiting
Faud Shihab, Site 0069, Phone: 801-585-3845

University Of Virginia Health System, Charlottesville, Virginia 22903, United States; Recruiting
Avinash Agarwal, Site 0011, Phone: 434-982-3665

Sentara Norfolk General Hospital, Norfolk, Virginia 23507, United States; Recruiting
Thomas Mccune, Site 0013, Phone: 757-388-7511

Local Institution, Richmond, Virginia 23298, United States; Not yet recruiting
Site 0103

Swedish Medical Center, Seattle, Washington 98104, United States; Recruiting
Nelson Goes, Site 0082, Phone: 206-215-3063

University Of Washington Medical Center, Seattle, Washington 98195, United States; Recruiting
Nicolae Leca, Site 0019, Phone: 206-598-1562

Providence Sacred Heart Medical Center, Spokane, Washington 99204, United States; Recruiting
Samer Bani Hani, Site 0021, Phone: 509-474-3821

University Of Wisconsin School Of Medicine & Public Health, Madison, Wisconsin 53705, United States; Recruiting
Arjang Djamali, Site 0097, Phone: 608-262-7115

Medical College Of Wisconsin, Milwaukee, Wisconsin 53226, United States; Recruiting
Brahm Vasudev, Site 0004, Phone: 414-805-0752

Additional Information

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BMS clinical trial educational resource

Investigator Inquiry form

FDA Safety Alerts and Recalls

Starting date: March 2013
Last updated: August 19, 2015

Page last updated: August 23, 2015

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