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

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01820572
• Other study ID #: IM103-116
• Secondary ID: 2012-001314-42
• Status: Completed
• Phase: Phase 3
• Start date: March 27, 2013
• Est. completion date: October 24, 2019

Study information

• Verified date: December 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 446
• Est. completion date: October 24, 2019
• Est. primary completion date: October 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Belatacept

• Tacrolimus

• Cyclosporine

Locations

Country	Name	City	State
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Caba
Argentina	Local Institution	Cardoba	Cordoba
Argentina	Local Institution	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Local Institution	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Local Institution	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Local Institution	Cordoba
Argentina	Local Institution	Mendoza	Buenos Aires
Argentina	Local Institution	Rosario	Santa FE
Argentina	Local Institution	Santa Fe
Austria	Local Institution	Feldkirch
Austria	Local Institution	Graz
Austria	Local Institution	Innsbruck
Austria	Local Institution	Linz
Austria	Local Institution	Wien
Colombia	Local Institution	Bogota
Colombia	Local Institution	Cali	Valle DEL Cauca
France	Local Institution	Bois-Guillaume
France	Local Institution	Bordeaux
France	Local Institution	Brest Cedex 2
France	Local Institution	Creteil
France	Local Institution	GRENOBLE Cedex 09
France	Local Institution	Le Kremilin Bicretre
France	Local Institution	Lyon Cedex 03
France	Local Institution	Paris	Cedex 15
France	Local Institution	Paris Cedex 10
France	Local Institution	Strasbourg Cedex
France	CHU Rangueil	Toulouse Cedex 8
Germany	Local Institution	Berlin
Germany	Local Institution	Dresden
Germany	Local Institution	Erlangen
Germany	Local Institution	Essen
Germany	Local Institution	Frankfurt am Main
Germany	Local Institution	Hamburg
Germany	Local Institution	Hannover
Germany	Local Institution	Heidelberg
Germany	Local Institution	Kiel
Germany	Local Institution	Lubeck
Germany	Local Institution	Mannheim
Germany	Local Institution	Muenchen
Germany	Local Institution	Munster
Germany	Local Institution	Regensburg
Germany	Local Institution	Wurzburg
Netherlands	Local Institution	Amsterdam
Netherlands	Local Institution	Amsterdam
Netherlands	Local Institution	Groningen
Netherlands	Local Institution	Leiden
Netherlands	Local Institution	Nijmegen
Netherlands	Local Institution	Utrecht
Norway	Local Institution	Oslo
Norway	Local Institution	Toensberg Norge
Sweden	Local Institution	Goteborg
Sweden	Local Institution	Stockholm
Sweden	Local Institution	Uppsala
Switzerland	Local Institution	Bern
Switzerland	Local Institution	Geneve 14
Switzerland	Local Institution	Zurich
United States	Emory University	Atlanta	Georgia
United States	Medical College of Georgia at Augusta University	Augusta	Georgia
United States	University of Colorado Denver (PI Address)	Aurora	Colorado
United States	UAB Division of Nephrology	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Buffalo	Buffalo	New York
United States	Medical University of South Carolina, SCTR Research Nexus	Charleston	South Carolina
United States	Carolinas Medical Center (PI Address)	Charlotte	North Carolina
United States	University of Virginia Health System (PI Address)	Charlottesville	Virginia
United States	RUSH University Transplant Program (PI Address)	Chicago	Illinois
United States	University of Wisconsin School of Medicine and Public Health (PI Address)	Chicago	Illinois
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Baylor University Medical Center	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Denver Nephrologists, PC	Denver	Colorado
United States	Henry Ford's Transplant Institute	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Baylor All Saints Medical Center at Ft. Worth	Fort Worth	Texas
United States	East Carolina Univ Nephrology Clin Res. Lab	Greenville	North Carolina
United States	Central PA Transplant Foundation	Harrisburg	Pennsylvania
United States	Baylor College of Medicine	Houston	Texas
United States	Memorial Hermann - Texas Medical Center (Tmc), The University Of Texas Medical School At Houston	Houston	Texas
United States	The Methodist Hospital	Houston	Texas
United States	University of Iowa Health Care (PI Address)	Iowa City	Iowa
United States	Saint Barnabas Medical Center	Livingston	New Jersey
United States	Loma Linda University Medical Center (LLUMC) - Children's Hospital - Transplantation Institute	Loma Linda	California
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Keck Medical Center of USC (PI Address)	Los Angeles	California
United States	Transplant Research Institute (PI Address)	Los Angeles	California
United States	UCLA Kidney Transplant Research Office	Los Angeles	California
United States	Methodist University Hospital Transplant Institute (PI Address)	Memphis	Tennessee
United States	Medical College of WI Froedtert Hospital	Milwaukee	Wisconsin
United States	Vanderbilt University Medical Center- GI Research Office	Nashville	Tennessee
United States	Yale Medical Group	New Haven	Connecticut
United States	Tulane University Health Sciences Center	New Orleans	Louisiana
United States	Recanati/Miller Transplantation Institue (PI Address)	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	University or Nebraska Medical Center	Omaha	Nebraska
United States	Florida Hospital Transplant Institute (PI Address)	Orlando	Florida
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania
United States	Penn Medicine	Philadelphia	Pennsylvania
United States	Mayo Clinic Hospital	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Maine Transplant Program	Portland	Maine
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	St. Clair Nephrology Research	Roseville	Michigan
United States	University of California, San Francisco (UCSF)-Kidney Transplant Service	Sacramento	California
United States	Washington Univ School of Med	Saint Louis	Missouri
United States	Central Pharmacy	Saint Petersburg	Florida
United States	University of Utah Depart of Nephrology (PI Address)	Salt Lake City	Utah
United States	California Institute Of Renal Research	San Diego	California
United States	California Pacific Medical Center, Depart of Transplantation (PI Address)	San Francisco	California
United States	UCSF Medical Center	San Francisco	California
United States	Swedish Medical Center-Swedish Organ Transplant and Liver Center	Seattle	Washington
United States	University of Washington Medical Center (PI Address & Study Supplies Address)	Seattle	Washington
United States	Providence Sacred Heart Medical Center and Childrens Hospital	Spokane	Washington
United States	Tampa General Medicine Group	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Colombia,  France,  Germany,  Netherlands,  Norway,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Survive With a Functional Graft at 24 Months	Percentage of participants who survive with a functional graft at 24 months post-randomization	at 24 Months
Secondary	Percentage of Participants Who Survive With a Functional Graft at 12 Months	Percentage of participants who survive with a functional graft at 12 months post-randomization	at 12 Months
Secondary	Number of Participants With a Biopsy Proven Acute Rejection (BPAR)	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
Secondary	Number of Participants With Varying Severity of BPAR	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
Secondary	Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Percent Change	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
Secondary	Mean Change From Baseline of Calculated Glomerular Filtration Rate (cGFR) - Adjusted Change	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
Secondary	Mean Calculated Glomerular Filtration Rate (cGFR)	Mean cGFR by study visit, as calculated by the 4-variable MDRD equation.	up to 24 months
Secondary	Slope Analysis of cGFR	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
Secondary	Slope Analysis of 1/Serum Creatinine	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
Secondary	Percentage of Participants With > 5% and >10% Improvement Over Baseline cGFR	Percentage of participants with > 5% and >10% improvement over baseline cGFR, at 12 and 24 months post-randomization	at 12 and 24 Months
Secondary	Mean Urine Protein/ Creatinine Ratio (UPCR)	Urine protein/ creatinine ratio (UPCR) at baseline, 3, 6, 12 and 24 months post randomization	Up to 24 Months
Secondary	Mean Change From Baseline in Systolic and Diastolic Blood Pressure	Mean change in systolic and diastolic blood pressure from baseline to 12 and 24 months post randomization	at 12 and 24 months
Secondary	Number of Antihypertensive Medications Used to Control Hypertension	The total number of antihypertensive medications used to control hypertension	at baseline, 12 and 24 Months
Secondary	Number of Participants With Donor Specific Antibodies (DSA)	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
Secondary	Mean Number of Symptom Occurrence and Symptom Distress	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
Secondary	Number of Participants With an Adverse Event of Special Interest	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
Secondary	Number of Participants With Marked Laboratory Abnormalities	Number of participants with Marked Laboratory Abnormalities	24 Months
Secondary	Mean Change From Baseline in Vital Signs: Heart Rate	The mean change from baseline in measured heart rate	at 12 and 24 months

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form