Belatacept Conversion Trial in Renal Transplantatio

Phase 1

Conditions: Subjects who received a kidney transplant

Registration Number: EUCTR2005-005238-11-FR

Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 170

Inclusion Criteria

1) The subject is willing to provide signed written informed consent
2) Subjects must be a recipient of a renal allograft from a living donor or a deceased donor at least 6 months, but not longer than 36 months, prior to randomization
3) Subjects must be receiving a CNI-based (CsA [any formulation] or TAC) immunosuppressive regimen
4) The dose of CNI must have been stable over the month prior to randomization
a) For subjects receiving CsA, trough serum concentration at the time of enrollment must be 100-250 ng/mL (based on screening/baseline central laboratory results)
b) For subjects receiving TAC, trough serum concentration at the time of enrollment must be 5-10 ng/mL (based on screening/baseline central laboratory results)
5) Subjects must be receiving adjunctive background maintenance immunosuppression with MMF, MPA, SRL, or AZA
a) Subjects receiving MMF must have received a minimum total daily dose of 1.5 g for the month prior to randomization (up to 3 missed doses are acceptable provided doses were not missed due to drug intolerance)
b) Subjects receiving MPA must have received a minimum total daily dose of 1080 mg for the month prior to randomization (up to 3 missed doses are acceptable provided doses were not missed due to drug intolerance)
c) Subjects receiving AZA must have received a minimum daily dose of 50 mg for the month prior to randomization (up to 3 missed doses are acceptable provided doses were not missed due to drug intolerance)
d) Subjects receiving SRL must have a trough serum concentration at the time of enrollment of 5-15 ng/mL (based on screening/baseline central laboratory results)
6) If subjects are receiving concomitant corticosteroids (steroid use is not required), the dose of corticosteroid must have been stable over the month prior to randomization with no anticipated dose alteration in the next 6 months
7) Subjects must have a calculated GFR = 35 and = 75 mL/min/1.73 m2 (MDRD formula) at the time of enrollment (based on screening/baseline central laboratory results)
8) Men and women, ages 18 years and older, inclusive
9) 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.
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

Exclusion Criteria

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 of study medication
2) WOCBP using a prohibited contraceptive method
3) Women who are pregnant or breastfeeding
4) Women with a positive pregnancy test on enrollment or prior to study drug
administration
5) 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
6) Subjects expected to undergo weaning of immunosuppressive therapy during the period of the study
7) Subjects with a pre-transplant panel reactive antibodies (PRA) = 50%
8) Subjects with previous graft loss due to acute rejection (AR)
9) Subjects whose SCr at enrollment is over 30% higher than 3 months (± 4 weeks) prior to randomization
10) Subjects with an episode of AR in the last 3 months. Subjects who have had an episode of AR are required to have had clinical resolution for at least 3 months prior to randomization
11) Subjects who have had a Banff 97 Grade IIA or greater AR (or equivalent), steroid-resistant AR or have received lymphocyte-depleting agents, plasmapheresis, or rituximab for the treatment of AR since transplantation of current allograft
12) Subjects who have experienced more than 1 episode of rejection of the current allograft
13) Subjects with a biopsy of the current allograft staining C4d positive. Neither a biopsy nor C4d staining is required for entry into the study
14) Subjects who have experienced complications of anastomotic stenosis or stricture (vascular or ureteral)
15) Subjects who had a positive T-cell or B-cell crossmatch
16) Subjects who have documented BK virus (polyoma virus) nephropathy (biopsy is not required for enrollment)
17) Subjects who have documented evidence of recurrence of the primary cause of end-stage renal disease (ESRD) in their current or in a past renal allograft
18) Subjects with multiple solid organ (heart, liver, pancreas) or cell (islet, bone marrow, stem cell) transplants
19) Subjects who received paired kidneys (dual or en bloc kidney transplants)
20) Subjects who are known hepatitis C antibody-positive or PCR-positive for hepatitis C (neither hepatitis C antibody or PCR for hepatitis C testing is required for entry into the study)
21) Subjects who are known hepatitis B surface antigen-positive or PCR-positive for
hepatitis B (neither hepatitis B surface antigen or PCR for hepatitis B testing is required for entry into the study)
22) Subjects with known HIV infection. HIV testing is not required for entry into the study
23) Subjects with a chest radiograph (posterior-anterior and lateral views) consistent with an acute lung parenchymal process, malignancy, or active tuberculosis. Subjects must have a chest radiograph within 2 months prior to randomization
24) Subjects with any significant infection

Medical History and Concurrent Diseases
25) Subjects whose life expectancy is severely limited by disease state or other underlying medical condition
26) Subjects with a history of cancer (other than non-melanoma skin cell cancers cured by local resection) within the last 5 years
27) 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

Physical and Laboratory Test Findings
28) Subjects with l

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

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