Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial (BENEFIT). + Pharmacogenetcis Blood Sample Amendment 01 - Site Specific - 04-Aug-05 + Exploratory Research Substudy Amendment Number 2 - Site Specific - Selected Sites, version 1.0 dated 29-Jun-06 Revised Protocol 01 incorporating Amendment 06 - BENEFIT
- Conditions
- TRANSPLANTATION,NOS
- Registration Number
- EUCTR2004-003635-31-GB
- Lead Sponsor
- Bristol Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 738
1) The subject is willing to provide signed written informed consent.
2) The subject is a recipient of a living donor or deceased donor kidney transplant
with an anticipated CIT < 24 hours.
3) Men and women, ages 18 and older, inclusive.
4) WOCBP must be using an adequate method of contraception to avoid pregnancy
throughout the study and for up to 8 weeks after the study in such a manner that
the risk of pregnancy is minimized.
WOCBP must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or
equivalent units of human chorionic gonadotropin [HCG]) within 72 hours prior to the
start of study medication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1) WOCBP who are unwilling or unable to use an acceptable method to avoid
pregnancy for the entire study period and for up to 8 weeks after the last infusion.
2) Women who are pregnant or breastfeeding.
3) Women with a positive pregnancy test on enrollment or prior to study drug
administration.
4) Genetically-identical donor recipient pairs (ie, identical twins)
5) Donor age < 10 years
6) Subjects receiving and extended criteria donor organ as defined by:
a) Donor age = 60 years
OR
b) Donor age 50 â 59 years and 1 of the following:
(i) Cerebrovascular accident (CVA) + hypertension + SCr > 1.5 mg/dL OR
(ii) CVA + hypertension OR
(iii) CVA + SCr > 1.5 mg/dL OR
(iv) Hypertension + SCr > 1.5 mg/dL
OR
c) Anticipated CIT = 24 hours
OR
d) Donor with cardiac death (non-heart beating donor)
7) Subjects with underlying renal disease of:
a) Primary focal segmental glomerulosclerosis
b) Type I or II membranoproliferative glomerulonephritis.
c) Hemolytic uremic syndrome (HUS) / thrombotic thrombocytopenic purpura
syndrome
8) Subjects undergoing primary (first-time) transplant with a current PRA = 50%, or
subjects undergoing retransplantation with a PRA = 30%.
9) Subjects with previous graft loss due to acute rejection.
10) Subjects with a positive T-cell lymphocytotoxic cross match.
11) Subjects with prior non-renal solid organ transplant (subjects undergoing kidney
retransplantation are eligible pending other study criteria being met), or subjects
undergoing multi-organ transplants (eg, kidney-pancreas) or subjects deemed
likely to have a second solid organ or cell transplant (eg, pancreas or islet transplant) in the next 3 years by the investigator.
12) Subjects receiving a concurrent solid organ (heart, liver, pancreas) or cell (islet,
bone marrow, stem cell) transplant.
13) Subjects receiving paired kidneys (dual or en bloc kidney transplants).
14) Subjects who are/whose allograft donor was known hepatitis C
antibody-positive or polymerase chain reaction (PCR)-positive for hepatitis C
15) Subjects who are/whose allograft donor was known hepatitis B surface
antigen-positive or PCR-positive for hepatitis B
16) Subjects and recipients of a graft from a donor with known human
immunodeficiency virus (HIV) infection
17) Subjects at risk for tuberculosis (TB). Specifically, subjects who:
a) Have current clinical, radiographic or laboratory evidence of active or latent
TB
b) Have a history of active TB (see Protocol)
c) In the opinion of the investigator, a risk of reactivation of TB that precludes the use of conventional immunosuppression.
18) Subjects with any active infection or other contraindication that would normally
exclude transplantation.
19) Subjects whose life expectancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method