Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00432497




Registration number
NCT00432497
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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sargramostim (Leukine)

Active comparator: Cyclosporine (CsA) -

Experimental: Belatacept LI (less intensive) -

Experimental: Belatacept MI (more intensive) -


Treatment: Drugs: Sargramostim (Leukine)
Open Label, 8 week cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

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)

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/NCT00432497