Clinical trial NCT00114777: Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant
Official title: Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial - Extended Criteria Donors (BENEFIT-EXT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Transplantation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-06-20
Enrollment: 595
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to learn if Belatacept is effective and safe as a first line of immunosuppression treatment in patients undergoing a renal transplant where the donor kidney is obtained in patients with extended criteria.


Eligibility criteria: Inclusion Criteria:

* Subject is a first-time recipient of a kidney transplant from a deceased donor.
* Specific donor criteria

Exclusion Criteria:

* Donor age \<10 years
* Subjects receiving a concurrent solid organ or cell transplant (lung, heart, etc.)
* Subjects with a positive T-cell lymphocytotoxic crossmatch.
* Subjects who are positive for Hepatitis B or C, or HIV
* Active tuberculosis
* History of cancer in the last 5 years
* History of substance abuse
* Specific laboratory results are exclusionary
* Mammography suspicious for cancer
* Allergy to iodine
* For Long-term extension study-Subjects who have completed three years of study treatment (through Week 156)

Primary outcomes:
measure: Percentage of Participants Who Survived With a Graft at 12 Months Post-Transplant
timeFrame: Month 12 post-transplant
measure: Percentage of Participants With a Measured Glomerular Filtration Rate (GFR) <60 mL/Min Per 1.73 m^2 at Month 12 or a Decrease in Measured GFR >=10 mL/Min Per 1.73 m^2 From Month 3 to Month 12
timeFrame: From Month 3 to Month 12
Secondary outcomes:
measure: Measured Glomerular Filtration Rate (GFR) by Month 12 and 24
timeFrame: At Month 12 and Month 24
measure: Percentage of Participants With Chronic Allograft Nephropathy (CAN) at Month 12
timeFrame: At Month 12
measure: Percentage of Participants Who Survived With a Graft at 24 and 36 Months Post-Transplant
timeFrame: Month 24 and Month 36 post-transplant
measure: Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months
timeFrame: Months 6, 12, 24, 36 and 84
measure: Change in Calculated GFR at Months 12, 24, 36 and 84
timeFrame: Baseline and Months 12, 24, 36 and 84
measure: Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months
timeFrame: Baseline and Months 12, 24 and 36
measure: Percentage of Subjects Who Used Anti-Hypertensive Medications to Control Hypertension at Months 12, 24 and 36
timeFrame: Months 12, 24 and 36
measure: Percentage of Participants With New Onset Diabetes Mellitus (NODM) at 12, 24 and 36 Months.
timeFrame: Months 12, 24 and 36
measure: Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months
timeFrame: Months 12, 24 and 36
measure: Mean Framingham Risk Score From Baseline to Months 12, 24 and 36
timeFrame: Baseline and Months 12, 24 and 36
measure: Percentage of Participants Using Lipid-Lowering Therapy at 12, 24, and 36 Months
timeFrame: Months 12, 24 and 36
measure: Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36
timeFrame: Months 12, 24 and 36
measure: Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84
timeFrame: Months 6, 12, 24, 36 and 84
measure: Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.
timeFrame: Months 6, 12, 24 and 36
measure: Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84
timeFrame: Months 6, 12, 24, 36 and 84
measure: Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36
timeFrame: Baseline and Months 12, 24 and 36
measure: Number of Participants With Clinically Significant Changes in Vital Signs up to 36 Months
timeFrame: Day 1 to Month 36
measure: Number of Participants With Laboratory Test Abnormalities up to 36 Months
timeFrame: Day 1 to Month 36
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36
timeFrame: Day 1 to Month 36
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84
timeFrame: Day 1 to Month 84
measure: Percentage of Participants With Graft Loss or Death to Month 84
timeFrame: Randomization to date of death, up to 84 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Of Alabama At Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: Ucla Kidney & Kidney-Pancreas Transplant Research Office
state: California
city: Los Angeles
country: United States
facility: National Institute Of Transplantation
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: San Francisco
country: United States
facility: University Of California San Francisco Medical Center
state: California
city: Aurora
country: United States
facility: University Of Colorado Health Sciences Center
state: Colorado
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: Tampa
country: United States
facility: Lifelink Healthcare Institute
state: Florida
city: Atlanta
country: United States
facility: Piedmont Transplant Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern University-Feinberg School Of Medicine
state: Illinois
city: Chicago
country: United States
facility: University Of Chicago Hospitals
state: Illinois
city: New Iberia
country: United States
facility: Acadiana Renal Physicians
state: Louisiana
city: New Orleans
country: United States
facility: Tulane Abdominal Transplant Institute
state: Louisiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Western New England Renal & Transplant Associates, Pc
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital, Transplant Institute
state: Michigan
city: Minneapolis
country: United States
facility: University Of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
city: New York
country: United States
facility: Mount Sinai School Of Medicine
state: New York
city: New York
country: United States
facility: Columbia University College Of Physicians & Surgeons
state: New York
city: Chapel Hill
country: United States
facility: University Of North Carolina At Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Drexel University College Of Medicine, Department Of Surgery
state: Pennsylvania
city: Philadelphia
country: United States
facility: University Of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Madison
country: United States
facility: University Of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert Memorial Hospital
state: Wisconsin
city: Capital Federal
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Cordoba, Crd
country: Argentina
facility: Local Institution
state: Cordoba
city: Rosario
country: Argentina
facility: Local Institution
state: Santa Fe
city: Santa Fe
country: Argentina
facility: Local Institution
city: Woodville
country: Australia
facility: Local Institution
state: South Australia
city: Innsbuck
country: Austria
facility: Local Institution
city: Vienna
country: Austria
facility: Local Institution
city: Leuven
country: Belgium
facility: Local Institution
city: Porto Alegre/rs
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Campinas/sp
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Rio De Janeiro
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Halifax
country: Canada
facility: Local Institution
state: Nova Scotia
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Saskatoon
country: Canada
facility: Local Institution
state: Saskatchewan
city: Santiago
country: Chile
facility: Local Institution
state: Metropolitana
city: Prague 4
country: Czechia
facility: Local Institution
city: Bordeaux
country: France
facility: Local Institution
city: Brest, Cedex 29
country: France
facility: Local Institution
city: Creteil
country: France
facility: Local Institution
city: Le Kremlin Bicetre Cedex
country: France
facility: Local Institution
city: Nante Cedex 01
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Toulouse Cedex
country: France
facility: Local Institution
city: Tours Cedex 09
country: France
facility: Local Institution
city: Vandoeuvre Les Nancy Cedex
country: France
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Erlangen
country: Germany
facility: Local Institution
city: Essen
country: Germany
facility: Local Institution
city: Hannover
country: Germany
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Szeged
country: Hungary
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Padova
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Oslo
country: Norway
facility: Local Institution
city: Poznan
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Pretoria
country: South Africa
facility: Local Institution
state: Gauteng
city: Barcelona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Malaga
country: Spain
facility: Local Institution
city: Gothenburg
country: Sweden
facility: Local Institution
city: Manchester
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Dobbels F, Wong S, Min Y, Sam J, Kalsekar A. Beneficial effect of belatacept on health-related quality of life and perceived side effects: results from the BENEFIT and BENEFIT-EXT trials. Transplantation. 2014 Nov 15;98(9):960-8. doi: 10.1097/TP.0000000000000159.
citation: Pestana JO, Grinyo JM, Vanrenterghem Y, Becker T, Campistol JM, Florman S, Garcia VD, Kamar N, Lang P, Manfro RC, Massari P, Rial MD, Schnitzler MA, Vitko S, Duan T, Block A, Harler MB, Durrbach A. Three-year outcomes from BENEFIT-EXT: a phase III study of belatacept versus cyclosporine in recipients of extended criteria donor kidneys. Am J Transplant. 2012 Mar;12(3):630-9. doi: 10.1111/j.1600-6143.2011.03914.x. Epub 2012 Feb 2.