Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial - EXTended Criteria Donors (BENEFIT-EXT)Amendment 1 and Revised protocol Number:01(Incorporates Amendment 2 & Administrative Letter 1) - BENEFIT-EXT
- Conditions
- TRANSPLANTATION, NOS
- Registration Number
- EUCTR2004-002974-48-ES
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
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:
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) CIT < 24 hours, donor age > 10 years
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.
6) Men must use an adequate method of contraception throughout the study, and for up to 8 weeks after the last infusion, so that the risk of pregnancy to their partners is minimized.
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 or with a positive pregnancy test on enrollment or prior to study drug administration
3) Males unwilling or unable to use an adequate method of contraception for the entire study period and for up to 8 weeks after the last infusion of study medication.
4) Donor age < 10 years
5) Subjects with underlying renal disease of:
a) Focal segmental glomerulosclerosis (biopsy proven)
b) Type I or II membranoproliferative glomerulonephritis
c) Hemolytic uremic syndrome/thrombotic thrombocytopenic purpura syndrome
6) Subjects with current PRA = 30%
7) Subjects with a positive T-cell lymphocytotoxic crossmatch
8) Subjects with any prior solid organ transplant (including kidney)
9) Subjects receiving a concurrent solid organ (heart, liver, pancreas) or cell (islet, bone marrow, stem cell) transplant
10) Subjects receiving paired kidneys from the extended criteria donor (dual kidney
transplant)
11) Subjects who are hepatitis C antibody-positive or polymerase chain reaction
(PCR)-positive for hepatitis C
12) Subjects who are hepatitis B surface antigen-positive or PCR-positive for hepatitis B
13) Subjects with known human immunodeficiency virus (HIV) infection.
14) 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
15) Subjects with any active infection or other contraindication that would normally exclude transplantation
16) Subjects whose life expectancy is severely limited by disease state or other
underlying medical condition
17) Subjects with a history of cancer (other than non-melanoma skin cell cancers cured by local resection) within the last 5 years
18) Subjects with a history of substance abuse (drug or alcohol) within the past 5 years, or, psychotic disorders that are not compatible with adequate study follow-up
19) Subjects with active peptic ulcer disease, chronic diarrhea, or gastrointestinal
malabsorption
20) Subjects with local laboratory values that are Common Toxicity Criteria (CTC)
Grade II or greater (Appendix 2) may not participate in the study. However, certain
specified laboratory parameters that are exceptions to CTC Grade II will be allowed.
See protocol section 5.2 for allowances.
21) All women 40 years or older and women of any age who have first degree relatives with a histor
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