Belatacept Pharmacokinetic Trial in Renal Transplantation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2012-09-30

Brief Summary

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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

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Detailed Description

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Conditions

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Renal Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

10mg/kg

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

Group Type ACTIVE_COMPARATOR

Belatacept

Intervention Type DRUG

IV infusion

B

5mg/kg

33 doses (every 4 weeks) for 144 weeks

Group Type ACTIVE_COMPARATOR

Belatacept

Intervention Type DRUG

IV infusion

Interventions

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Belatacept

IV infusion

Intervention Type DRUG

Other Intervention Names

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BMS-224818

Eligibility Criteria

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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