Belatacept Pharmacokinetic Trial in Renal Transplantation

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Renal Transplantation

Treatments: Drug: Belatacept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00578448

IM103-047

Details and patient eligibility

About

The purpose of this study is to assess the pharmacokinetics and safety of belatacept in de novo renal transplant subjects treated with belatacept-based immunosuppressant medication

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Recipient of a living or deceased donor kidney
• First or second transplant
• Men and women, including women of childbearing potential, 18 years and older

Exclusion criteria

• Panel reactive antibodies ≥ 30%
• Significant infection

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

A

Active Comparator group

Description:

10mg/kg 6 doses (Day 1, 5, week 2, 4, 8 and 12) for 12 weeks

Treatment:

Drug: Belatacept

B

Active Comparator group

Description:

5mg/kg 33 doses (every 4 weeks) for 144 weeks

Treatment:

Drug: Belatacept