A Randomized, Open-Label, Multicenter, Parallel-Group Study of Belatacept-Based Corticosteroid-Free Regimens in Renal Transplant+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific, version 2.0 dated 08-Jan-07Estudio aleatorizado, abierto, multicéntrico y de grupos paralelos, de tratamientos para trasplante renal basados en belatacept y libre de corticosteroides

Phase 1

• Conditions: Subjects receiving a kidney transplant from a living donor or a deceased donor.Pacientes que reciben un trasplante renal de donante vivo o cadaver; MedDRA version: 9.1Level: LLTClassification code 10038533Term: Renal transplant

• Registration Number: EUCTR2006-003114-17-ES
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2009-05-04
• Study Start: 2010-03-10
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

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

Inclusion Criteria

1) 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

1) Sex and Reproductive Status
a) 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]
b) WOCBP using a prohibited contraceptive method
c) Women who are pregnant or breastfeeding
d) Women with a positive pregnancy test on enrollment or prior to investigational product administration

2) Target Disease Exceptions
a) Donor Exceptions:
1) Donor age < 10 years or > 60 years
2) Donor with cardiac death
3) Cold ischemia time = 24 hours
4) Donors who are known hepatitis C antibody-positive or PCR positive for hepatitis C
5) Donors who are known hepatitis B surface antigen-positive or PCR positive for hepatitis B
6) Donors with known HIV infection
b) Recipient Exceptions:
1) Genetically identical donor recipient pairs
2) Recipients whose serology is negative for EBV
3) Subjects with underlying renal disease of:
- Primary focal segmental glomerulosclerosis
- Type I or II membranoproliferative glomerulonephritis
- 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 determined by the investigator
4) Subjects undergoing primary renal transplant with current PRA = 50% or subjects undergoing retransplantation with a PRA > 30%
5) Subjects with previous graft loss due to AR
6) Subjects with a positive T-cell or B-cell crossmatch
7) 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 in next 12 months
8) Subjects receiving a concurrent SOT or cell transplant
9) Subjects receiving paired kidneys

3) Medical History and Concurrent Diseases
a) Subjects who are known hepatitis C antibody-positive or PCR-positive for hepatitis C
b) Subjects who are known hepatitis B surface antigen-positive or PCR-positive for hepatitis B
c) Subjects with known HIV infection
d) Subjects with a chest radiograph consistent with an acute lung parenchymal process and malignancy.
e) Subjects at risk for tuberculosis (TB). Specifically, subjects:
1) With current clinical, radiographic, or laboratory evidence of active or latent TB as determined by local standard of care.
2) With history of active TB:
- Within the last 2 years, even if it was treated
- Greater than 2 years ago, unless there is documentation of adequate treatment according to locally accepted clinical practice
3) In the opinion of the investigator and based upon appropriate evaluation, a subject whose risk of reactivation of TB precludes administration of conventional immunosuppression
f) Subjects with any significant infection or other contraindication that would normally preclude transplantation
g) Subjects whose life expectancy is severely limited by disease state or other underlying medical condition
h) Subjects with a history of cancer within the last 5 years
i) Subjects with a history of drug or alcohol abuse within the past 5 years, or psychotic disorders that are not compatible with adequate study followup
j) Subjects with active peptic ulcer disease, ch

Study & Design

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