Completed

A Phase 2 Multi-Center, Randomized Conversion Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Belatacept Administered to Pediatric Subjects With a Stable Renal Transplant

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What is being tested

Belatacept

Drug
Who is being recruted

From 12 to 17 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2013
See protocol details

Summary

Principal SponsorBristol-Myers Squibb
Last updated: July 24, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: May 9, 2013

Actual date on which the first participant was enrolled.

The purpose of this study is to evaluate how well adolescent kidney transplant patients tolerate a single dose of belatacept they receive at least 6 months after transplant surgery, and how their body handles the drug.

NCT01791491
Principal SponsorBristol-Myers Squibb
Last updated: July 24, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

16 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 12 to 17 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 exclusion criteria prevent from participating
Epstein-Barr virus (EBV) serostatus negative or unknown at time of transplant and screening
History of any treated or biopsy proven acute rejection (BPAR) within 3 months prior to enrollment
Subjects who have experienced more than 1 episode of acute rejection (AR) of the current allograft or any antibody-mediated AR
Subjects with any active infection [including, but not limited to, positive cytomegalovirus (CMV) or BK viral (BKV) loads, BKV associated nephropathy (BKVAN), CMV retinitis, CMV colitis, etc.]
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

University Of Alabama At Birmingham

Birmingham, United StatesOpen University Of Alabama At Birmingham in Google Maps

Childrens Hospital Of La

Los Angeles, United States

University Of California Los Angeles

Los Angeles, United States

Stanford University Medical Center

Stanford, United States
Completed8 Study Centers