Trials / Completed
CompletedNCT01791491
Pharmacokinetics, Safety and Tolerability of Single-dose Belatacept in Adolescent Kidney Transplant Recipients
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Belatacept | Single intravenous infusion of belatacept, 7.5 mg/kg |
Timeline
- Start date
- 2013-05-09
- Primary completion
- 2016-12-06
- Completion
- 2016-12-06
- First posted
- 2013-02-15
- Last updated
- 2017-07-24
- Results posted
- 2017-06-26
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01791491. Inclusion in this directory is not an endorsement.