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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00114777




Registration number
NCT00114777
Ethics application status
Date submitted
17/06/2005
Date registered
20/06/2005
Date last updated
7/07/2017

Titles & IDs
Public title
Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant
Scientific title
Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial - Extended Criteria Donors (BENEFIT-EXT)
Secondary ID [1] 0 0
IM103-027
Universal Trial Number (UTN)
Trial acronym
BENEFIT-EXT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Transplantation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cyclosporin A
Treatment: Drugs - Belatacept Less Intensive Regimen (LI)
Treatment: Drugs - Belatacept More Intensive Regimen (MI)

Active comparator: Cyclosporin A -

Experimental: Belatacept Less Intensive Regimen (LI) -

Experimental: Belatacept More Intensive Regimen (MI) -


Treatment: Drugs: Cyclosporin A
tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months, 100-250 ng/mL, daily, 84 months

Treatment: Drugs: Belatacept Less Intensive Regimen (LI)
solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months months, 5 mg/kg every 4 weeks, q 4 weeks, 84 months

Treatment: Drugs: Belatacept More Intensive Regimen (MI)
solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months, 5 mg/kg every 4 weeks, q 4 weeks, 84 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Survived With a Graft at 12 Months Post-Transplant
Timepoint [1] 0 0
Month 12 post-transplant
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
From Month 3 to Month 12
Secondary outcome [1] 0 0
Measured Glomerular Filtration Rate (GFR) by Month 12 and 24
Timepoint [1] 0 0
At Month 12 and Month 24
Secondary outcome [2] 0 0
Percentage of Participants With Chronic Allograft Nephropathy (CAN) at Month 12
Timepoint [2] 0 0
At Month 12
Secondary outcome [3] 0 0
Percentage of Participants Who Survived With a Graft at 24 and 36 Months Post-Transplant
Timepoint [3] 0 0
Month 24 and Month 36 post-transplant
Secondary outcome [4] 0 0
Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months
Timepoint [4] 0 0
Months 6, 12, 24, 36 and 84
Secondary outcome [5] 0 0
Change in Calculated GFR at Months 12, 24, 36 and 84
Timepoint [5] 0 0
Baseline and Months 12, 24, 36 and 84
Secondary outcome [6] 0 0
Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months
Timepoint [6] 0 0
Baseline and Months 12, 24 and 36
Secondary outcome [7] 0 0
Percentage of Subjects Who Used Anti-Hypertensive Medications to Control Hypertension at Months 12, 24 and 36
Timepoint [7] 0 0
Months 12, 24 and 36
Secondary outcome [8] 0 0
Percentage of Participants With New Onset Diabetes Mellitus (NODM) at 12, 24 and 36 Months.
Timepoint [8] 0 0
Months 12, 24 and 36
Secondary outcome [9] 0 0
Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months
Timepoint [9] 0 0
Months 12, 24 and 36
Secondary outcome [10] 0 0
Mean Framingham Risk Score From Baseline to Months 12, 24 and 36
Timepoint [10] 0 0
Baseline and Months 12, 24 and 36
Secondary outcome [11] 0 0
Percentage of Participants Using Lipid-Lowering Therapy at 12, 24, and 36 Months
Timepoint [11] 0 0
Months 12, 24 and 36
Secondary outcome [12] 0 0
Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36
Timepoint [12] 0 0
Months 12, 24 and 36
Secondary outcome [13] 0 0
Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84
Timepoint [13] 0 0
Months 6, 12, 24, 36 and 84
Secondary outcome [14] 0 0
Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.
Timepoint [14] 0 0
Months 6, 12, 24 and 36
Secondary outcome [15] 0 0
Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84
Timepoint [15] 0 0
Months 6, 12, 24, 36 and 84
Secondary outcome [16] 0 0
Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36
Timepoint [16] 0 0
Baseline and Months 12, 24 and 36
Secondary outcome [17] 0 0
Number of Participants With Clinically Significant Changes in Vital Signs up to 36 Months
Timepoint [17] 0 0
Day 1 to Month 36
Secondary outcome [18] 0 0
Number of Participants With Laboratory Test Abnormalities up to 36 Months
Timepoint [18] 0 0
Day 1 to Month 36
Secondary outcome [19] 0 0
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
Timepoint [19] 0 0
Day 1 to Month 36
Secondary outcome [20] 0 0
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
Timepoint [20] 0 0
Day 1 to Month 84
Secondary outcome [21] 0 0
Percentage of Participants With Graft Loss or Death to Month 84
Timepoint [21] 0 0
Randomization to date of death, up to 84 months

Eligibility
Key inclusion criteria
* Subject is a first-time recipient of a kidney transplant from a deceased donor.
* Specific donor criteria
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2014
Sample size
Target
Accrual to date
Final
595
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Local Institution - Woodville
Recruitment postcode(s) [1] 0 0
5011 - Woodville
Recruitment outside Australia
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United States of America
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Alabama
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California
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Colorado
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Connecticut
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Missouri
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Creteil
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France
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Vandoeuvre Les Nancy Cedex
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Germany
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Berlin
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Germany
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Erlangen
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Germany
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Essen
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Germany
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Hannover
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Hungary
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Budapest
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Hungary
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Szeged
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Italy
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Milano
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Italy
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Padova
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Italy
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Roma
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Norway
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Oslo
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Poland
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Poznan
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Poland
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Warszawa
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South Africa
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Gauteng
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Spain
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Barcelona
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Madrid
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Spain
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Malaga
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Sweden
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Gothenburg
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United Kingdom
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00114777
Trial related presentations / publications
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00114777