Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial - EXTended Criteria Donors (BENEFIT-EXT). Revised Protocol Number 03 incorporating Administrative Letters # 2, 4 & 5 + Amendments 05 (version 1.0 dated 28-Sep-07) and 08 (version 1.0 dated 13-Feb-09) + Protocol Amendment 1 and Protocol Amendment 04 - Site Specific - BENEFIT-EXT
- Conditions
- TRANSPLANTATION, NOS
- Registration Number
- EUCTR2004-002974-48-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
- 595
1) The subject is willing to provide signed written informed consent;
2) The subject is a first-time recipient of a deceased donor kidney transplant;
3) The donor and/or donor kidney meet at least 1 of the following extended criteria
for organ donation:
a) Donor age >= 60 years
OR
b) Donor age 50 – 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 (subjects should not be randomized if actual CIT
is < 20 hours)
OR
d) Donor with cardiac death (non-heart beating donor)
4) Men and women, ages 18 and older, inclusive
5) 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.
It should be noted that according to the US product information for mycophenolate mofetil (CellCept®), two reliable forms of contraception must be used simultaneously unless abstinence is the chosen method.
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 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;
If a subject has ESRD of unknown etiology and/or has no histologically-confirmed
diagnosis, the subject may be enrolled into the study as long as there are no clinical signs or symptoms consistent with the clinical diagnosis of primary focal segmental
glomerulosclerosis, Type I or II membranoproliferative glomerulonephritis, or HUS, as
deemed by the investigator.
7) Subjects with current PRA >= 30%;
8) Subjects with a positive T-cell lymphocytotoxic crossmatch;
9) Subjects with any prior solid organ transplant (including kidney);
10) Subjects receiving a concurrent solid organ (heart, liver, pancreas) or cell (islet, bone marrow, stem cell) transplant 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;
11) Subjects receiving paired kidneys from the extended criteria donor (dual kidney
transplant);
12) Subjects who are hepatitis C antibody-positive or polymerase chain reaction
(PCR)-positive for hepatitis C;
13) Subjects who are hepatitis B surface antigen-positive or PCR-positive for hepatitis B;
14) Subjects with known human immunodeficiency virus (HIV) infection;
15) Subjects with active tuberculosis (TB) requiring treatment within the previous 3 years or any subject who previously required triple (or more) combination therapy for TB. Subjects with a known positive purified protein derivative (PPD) will not be eligible for the study unless they completed treatment for latent TB and have a negative chest x-ray at the time of enrollment. PPD testing done within the last 12 months is acceptable as long as there is documentation of the results. Subjects without a PPD in the last 12 months who have a previous negative result may be enrolled if they also have a negative chest x-ray at enrollment, no symptoms indicative of TB, no known TB contacts, not currently residing in, recently traveled to, or previously immigrated from an area endemic for TB. A PPD response that is >= 10 mm induration or a Heaf score of > 1 in non-Bacille Calmette-Guérin (non-BCG) immunized subjects or > 2 in BCG immunized subjects should be considered a positive test. More conservative criteria may be applied according to the published guidelines and/or local standards endorsed by the medical society;
16) Subjects with any active infection or other contraindication that would normally
exclude transplant
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