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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00256750




Registration number
NCT00256750
Ethics application status
Date submitted
15/11/2005
Date registered
22/11/2005
Date last updated
19/08/2016

Titles & IDs
Public title
Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT)
Scientific title
Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial (BENEFIT)
Secondary ID [1] 0 0
IM103-008
Universal Trial Number (UTN)
Trial acronym
BENEFIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Transplantation 0 0
Chronic Kidney Failure 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cyclosporine (CsA)
Treatment: Drugs - Belatacept LI (less intensive)
Treatment: Drugs - Belatacept MI (more intensive)

Active comparator: Cyclosporine (CsA) -

Experimental: Belatacept LI (less intensive) -

Experimental: Belatacept MI (more intensive) -


Treatment: Drugs: Cyclosporine (CsA)
tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months (ST), 100-250 ng/mL, daily, 24 months (LT)

Treatment: Drugs: Belatacept LI (less intensive)
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 (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)

Treatment: Drugs: Belatacept MI (more intensive)
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 (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent of Participants Surviving With a Functioning Graft by Month 12
Timepoint [1] 0 0
Day 1 to Month 12
Primary outcome [2] 0 0
Percent of Participants With a Composite of Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12 or With a Decrease in mGFR Greater Than or Equal to 10 mL/Min/1.73m^2 From Month 3 to Month 12
Timepoint [2] 0 0
Month 12; Month 3 to Month 12
Primary outcome [3] 0 0
Percent of Participants Experiencing Acute Rejection (AR) Post-transplant by Month 12
Timepoint [3] 0 0
Day 1 to Month 12
Secondary outcome [1] 0 0
Mean Value of the Measured Glomerular Filtration Rate (mGFR)
Timepoint [1] 0 0
Months 3, 12, 24
Secondary outcome [2] 0 0
Percent of Participants With Prevalence of Chronic Allograft Nephropathy (CAN) at Month 12
Timepoint [2] 0 0
Month 12
Secondary outcome [3] 0 0
Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events by Month 84
Timepoint [3] 0 0
Randomization to Month 84
Secondary outcome [4] 0 0
Number of Participants With Adverse Events of Special Interest by Month 84
Timepoint [4] 0 0
Randomization to Month 84
Secondary outcome [5] 0 0
Mean Blood Pressure at Month 84
Timepoint [5] 0 0
Month 84
Secondary outcome [6] 0 0
Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36
Timepoint [6] 0 0
Baseline to Month 36
Secondary outcome [7] 0 0
Percent of Participants With Development of Anti-Donor HLA Positive Antibodies by Month 84
Timepoint [7] 0 0
Randomization to Month 84
Secondary outcome [8] 0 0
Mean Change of the Measured Glomerular Filtration Rate (mGFR) From Month 3 to Month 12 and From Month 3 to Month 24
Timepoint [8] 0 0
Month 3 to Month 12; Month 3 to Month 24
Secondary outcome [9] 0 0
Percent of Participants With a Decrease in Measured Glomerular Filtration Rate (mGFR) Greater Than or Equal to 10mL/Min/1.73m^2 From Month 3 to Month 12
Timepoint [9] 0 0
Month 3 to Month 12
Secondary outcome [10] 0 0
Percent of Participants With a Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12
Timepoint [10] 0 0
Month 12
Secondary outcome [11] 0 0
Mean Value of the Calculated Glomerular Filtration Rate (cGFR) With Imputation
Timepoint [11] 0 0
Months 6, 12, 24, 36
Secondary outcome [12] 0 0
Mean Change in Calculated Glomerular Filtration Rate (cGFR) From Month 6 to Month 12
Timepoint [12] 0 0
Month 6 to Month 12
Secondary outcome [13] 0 0
Percent of Participants With Incidence of New Onset Diabetes Mellitus by Month 36
Timepoint [13] 0 0
Week 4 post-transplantation to Month 36
Secondary outcome [14] 0 0
Percent of Participants Using At Least One Anti-Hypertensive Medication to Control Hypertension at Month 36
Timepoint [14] 0 0
Month 36
Secondary outcome [15] 0 0
Percent of Participants With Incidence of Hypertension Post-Transplantation at Month 12
Timepoint [15] 0 0
Month 12
Secondary outcome [16] 0 0
Percent of Participants With Prevalence of Hypertension Post-Transplantation at Month 12
Timepoint [16] 0 0
Month 12
Secondary outcome [17] 0 0
Mean Systolic Blood Pressure and Diastolic Blood Pressure
Timepoint [17] 0 0
Months 12, 24, 36
Secondary outcome [18] 0 0
Percent of Participants at Baseline With Controlled Hypertension Post Transplantation by Month 12
Timepoint [18] 0 0
Day 1 to Month 12
Secondary outcome [19] 0 0
Percent of Participants With Prevalence of Controlled Hypertension at Month 12
Timepoint [19] 0 0
Month 12
Secondary outcome [20] 0 0
Percent of Non-dyslipidemic Participants With Incidence of Dyslipidemia Post-Transplantation by Month 12
Timepoint [20] 0 0
Randomization to Month 12
Secondary outcome [21] 0 0
Percent of Participants With Prevalence of Dyslipidemia at Month 12
Timepoint [21] 0 0
Month 12
Secondary outcome [22] 0 0
Percent of Participants With Controlled Dyslipidemia at Month 12
Timepoint [22] 0 0
Month 12
Secondary outcome [23] 0 0
Number of Participants With Antihyperlipidemic Medication by Intensity Level
Timepoint [23] 0 0
Month 36
Secondary outcome [24] 0 0
Percent of Participants Using At Least One Anti-Hyperlipidemic Medication
Timepoint [24] 0 0
Month 36
Secondary outcome [25] 0 0
Mean Value of Lipid Parameters
Timepoint [25] 0 0
Months 12, 24, 36
Secondary outcome [26] 0 0
Percent of Participants With Prevalence of Acute Rejection (AR) by Month 36
Timepoint [26] 0 0
Randomization to Month 36
Secondary outcome [27] 0 0
Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36
Timepoint [27] 0 0
Randomization to Month 36
Secondary outcome [28] 0 0
Percent of Participants Using Polyclonal Antilymphocyte Preparations for Impaired Renal Function and Anticipated Delayed Graft Function by Month 12
Timepoint [28] 0 0
Randomization to Month 12
Secondary outcome [29] 0 0
Percent of Participants Using Lymphocyte Depleting Therapy (LDT) for the Initial Treatment of Acute Rejection (AR) by Month 36
Timepoint [29] 0 0
Randomization to Month 36
Secondary outcome [30] 0 0
Percent of Participants With Corticosteroid Resistant Acute Rejection (AR) by Month 36
Timepoint [30] 0 0
Randomization to Month 36
Secondary outcome [31] 0 0
Number of Participants Who Recovered Completely From an Episode of Acute Rejection (AR) by Month 12
Timepoint [31] 0 0
Randomization to Month 12
Secondary outcome [32] 0 0
Percent of Participants With Subclinical Rejection at Month 12
Timepoint [32] 0 0
Month 12
Secondary outcome [33] 0 0
Number of Participants Treated for Acute Rejection (AR) Regardless of Histological Findings by Month 36
Timepoint [33] 0 0
Randomization to Month 36
Secondary outcome [34] 0 0
Mean Value of Physical and Mental Components Using SF-36 Questionnaire
Timepoint [34] 0 0
Months 6, 12, 24, 36
Secondary outcome [35] 0 0
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire
Timepoint [35] 0 0
Months 6, 12, 24, 36
Secondary outcome [36] 0 0
Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R)
Timepoint [36] 0 0
Months 6, 12, 24, 36
Secondary outcome [37] 0 0
Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36
Timepoint [37] 0 0
Baseline to Months 6, 12, 24,and 36
Secondary outcome [38] 0 0
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36
Timepoint [38] 0 0
Baseline to Months 6, 12, 24, and 36
Secondary outcome [39] 0 0
Percent of Participants Surviving With a Functioning Graft
Timepoint [39] 0 0
Months 24, 36
Secondary outcome [40] 0 0
Percent of Participants With Composite Endpoint or Death, Graft Loss or Acute Rejection by Month 36
Timepoint [40] 0 0
Randomization to Month 36

Eligibility
Key inclusion criteria
* The subject is a recipient of a living donor or deceased donor kidney transplant.
* Male or Female, 18 or older
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* First time recipient, PRA >- 50% or for retransplantation PRA >- 30%.
* If retransplantation, previous graft loss cannot be due to acute rejection.
* Positive cross match.
* Subject receiving extended criteria donor (ECD) organ
* 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
1/03/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2015
Sample size
Target
Accrual to date
Final
738
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Camperdown
Recruitment hospital [2] 0 0
Local Institution - Westmead
Recruitment hospital [3] 0 0
Local Institution - Adelaide
Recruitment hospital [4] 0 0
Local Institution - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3052 - Parkville
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
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Maine
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Vermont
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
United States of America
State/province [23] 0 0
Wisconsin
Country [24] 0 0
Argentina
State/province [24] 0 0
Buenos Aires
Country [25] 0 0
Argentina
State/province [25] 0 0
Cordoba
Country [26] 0 0
Argentina
State/province [26] 0 0
Santa Fe
Country [27] 0 0
Austria
State/province [27] 0 0
Innsbuck
Country [28] 0 0
Austria
State/province [28] 0 0
Vienna
Country [29] 0 0
Belgium
State/province [29] 0 0
Gent
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Belgium
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Leuven
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Brazil
State/province [31] 0 0
Rio De Janeiro
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Brazil
State/province [32] 0 0
Rio Grande Do Sul
Country [33] 0 0
Brazil
State/province [33] 0 0
Sao Paulo
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Canada
State/province [34] 0 0
Alberta
Country [35] 0 0
Canada
State/province [35] 0 0
Nova Scotia
Country [36] 0 0
Canada
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Quebec
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Canada
State/province [37] 0 0
Saskatchewan
Country [38] 0 0
Czech Republic
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Praha 4
Country [39] 0 0
France
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Bordeaux
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France
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Brest Cedex
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France
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Creteil
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France
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Grenoble Cedex 9
Country [43] 0 0
France
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Nante Cedex 01
Country [44] 0 0
France
State/province [44] 0 0
Paris
Country [45] 0 0
France
State/province [45] 0 0
Toulouse
Country [46] 0 0
Germany
State/province [46] 0 0
Berlin
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Germany
State/province [47] 0 0
Erlangen
Country [48] 0 0
Germany
State/province [48] 0 0
Essen
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Germany
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Hannover
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Hungary
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Szeged
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India
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Ahmedabad
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India
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Gujarat
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India
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Gujrat
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India
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Kerala
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India
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Maharashtra
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India
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Chandigarh
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India
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Chennai
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India
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Lucknow
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India
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New Delhi
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Israel
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Petah Tikva
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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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Mexico
State/province [64] 0 0
Distrito Federal
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Mexico
State/province [65] 0 0
Morelos
Country [66] 0 0
Mexico
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Nuevo Leon
Country [67] 0 0
Mexico
State/province [67] 0 0
Aguascalientes
Country [68] 0 0
Mexico
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San Luis Potosi
Country [69] 0 0
Poland
State/province [69] 0 0
Poznan
Country [70] 0 0
Poland
State/province [70] 0 0
Szczecin
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South Africa
State/province [71] 0 0
Cape Town
Country [72] 0 0
South Africa
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Gauteng
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South Africa
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Kwa Zulu Natal
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Malaga
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Sweden
State/province [77] 0 0
Goteborg
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Switzerland
State/province [78] 0 0
Bern
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Switzerland
State/province [79] 0 0
Zurich
Country [80] 0 0
Turkey
State/province [80] 0 0
Antalya

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/NCT00256750