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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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Wisconsin
Country [18] 0 0
Argentina
State/province [18] 0 0
Buenos Aires
Country [19] 0 0
Argentina
State/province [19] 0 0
Cordoba
Country [20] 0 0
Argentina
State/province [20] 0 0
Santa Fe
Country [21] 0 0
Austria
State/province [21] 0 0
Innsbuck
Country [22] 0 0
Austria
State/province [22] 0 0
Vienna
Country [23] 0 0
Belgium
State/province [23] 0 0
Leuven
Country [24] 0 0
Brazil
State/province [24] 0 0
Rio Grande Do Sul
Country [25] 0 0
Brazil
State/province [25] 0 0
Sao Paulo
Country [26] 0 0
Brazil
State/province [26] 0 0
Rio De Janeiro
Country [27] 0 0
Canada
State/province [27] 0 0
Alberta
Country [28] 0 0
Canada
State/province [28] 0 0
Nova Scotia
Country [29] 0 0
Canada
State/province [29] 0 0
Quebec
Country [30] 0 0
Canada
State/province [30] 0 0
Saskatchewan
Country [31] 0 0
Chile
State/province [31] 0 0
Metropolitana
Country [32] 0 0
Czechia
State/province [32] 0 0
Prague 4
Country [33] 0 0
France
State/province [33] 0 0
Bordeaux
Country [34] 0 0
France
State/province [34] 0 0
Brest, Cedex 29
Country [35] 0 0
France
State/province [35] 0 0
Creteil
Country [36] 0 0
France
State/province [36] 0 0
Le Kremlin Bicetre Cedex
Country [37] 0 0
France
State/province [37] 0 0
Nante Cedex 01
Country [38] 0 0
France
State/province [38] 0 0
Paris
Country [39] 0 0
France
State/province [39] 0 0
Toulouse Cedex
Country [40] 0 0
France
State/province [40] 0 0
Tours Cedex 09
Country [41] 0 0
France
State/province [41] 0 0
Vandoeuvre Les Nancy Cedex
Country [42] 0 0
Germany
State/province [42] 0 0
Berlin
Country [43] 0 0
Germany
State/province [43] 0 0
Erlangen
Country [44] 0 0
Germany
State/province [44] 0 0
Essen
Country [45] 0 0
Germany
State/province [45] 0 0
Hannover
Country [46] 0 0
Hungary
State/province [46] 0 0
Budapest
Country [47] 0 0
Hungary
State/province [47] 0 0
Szeged
Country [48] 0 0
Italy
State/province [48] 0 0
Milano
Country [49] 0 0
Italy
State/province [49] 0 0
Padova
Country [50] 0 0
Italy
State/province [50] 0 0
Roma
Country [51] 0 0
Norway
State/province [51] 0 0
Oslo
Country [52] 0 0
Poland
State/province [52] 0 0
Poznan
Country [53] 0 0
Poland
State/province [53] 0 0
Warszawa
Country [54] 0 0
South Africa
State/province [54] 0 0
Gauteng
Country [55] 0 0
Spain
State/province [55] 0 0
Barcelona
Country [56] 0 0
Spain
State/province [56] 0 0
Madrid
Country [57] 0 0
Spain
State/province [57] 0 0
Malaga
Country [58] 0 0
Sweden
State/province [58] 0 0
Gothenburg
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Manchester

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00114777