A randomized,open-label,multicenter, parallel-group study of belatacept-based corticosteroid-free regimens in renal transplant - ND

• Conditions: Subjects receiving a kidney transplant from a living donor or a deceased donor; MedDRA version: 9.1Level: LLTClassification code 10038533Term: Renal transplant

• Registration Number: EUCTR2006-003114-17-IT
• Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-29
• Last Update Posted: 25 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1) Signed Written Informed Consent

a) The subject is willing to provide signed written informed consent

2) Target Population

a) The subject must be a recipient of a renal allograft from a living donor or a

deceased donor

b) The subject will have reliable i.v. access

3) Age and Sex

a) Men and women, ages 18 to 70 years, inclusive

b) Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study [and for up to 8 weeks after the last dose of investigational product] 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

- Donor Exceptions:

Donor age < 10 years or > 60 years

Donor with cardiac death (non-heart beating donor)

Cold ischemia time >= 24 hours

Donors who are known hepatitis C antibody-positive or polymerase chain

reaction (PCR) positive for hepatitis C

Donors who are known hepatitis B surface antigen-positive or PCR positive

for hepatitis B

Donors with known human immunodeficiency virus (HIV) infection

- Sex and Reproductive status:

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 dose of

investigational product]

WOCBP using a prohibited contraceptive method

Women who are pregnant or breastfeeding

Women with a positive pregnancy test on enrollment or prior to investigational

product administration.

- Recipient Exceptions:

Genetically identical donor recipient pairs (ie, identical twins)

Recipients whose serology is negative for EBV (documented at the time of

evaluation for transplant)

Subjects undergoing primary (first time) renal transplant with current PRA

>= 50% or subjects undergoing retransplantation with a PRA > 30%

Subjects with prior non-renal solid organ transplant (SOT) (subjects

undergoing kidney retransplantation are eligible assuming other study criteria

are met), or subjects deemed likely to have a second SOT or cell transplant

(eg, pancreas or islet cell) in next 12 months.

Subjects who are known hepatitis C antibody-positive or polymerase chain

reaction (PCR)-positive for hepatitis C

Subjects who are known hepatitis B surface antigen-positive or PCR-positive for

hepatitis B

Subjects with known human immunodeficiency virus (HIV) infection

Subjects at risk for tuberculosis (TB).

Body mass index > 35 kg/m2

Subjects who have used any investigational drug within 30 days prior to the Day 1

visit

Subjects previously treated with belatacept

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified