Trials / Completed
CompletedNCT02592798
Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Adults and Children 6 Years and Older With Excessive Loss of Protein in the Urine Due to Either Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)
A Phase II Randomized, Placebo-Controlled, Double-Blind, Parallel Arms, Pilot Study to Evaluate the Efficacy and Safety of Intravenous Abatacept in Treatment Resistant Nephrotic Syndrome (Focal Segmental Glomerulosclerosis/ Minimal Change Disease)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 6 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is evaluate if abatacept is effective and safe in decreasing the level of protein loss in the urine in patients with excessive loss of protein in the urine (nephrotic syndrome) due to either focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD). Candidates must have a prior kidney biopsy with either diagnosis. Another kidney biopsy will not be required as part of the study. Candidates must have failed or be intolerant of prior therapy for their kidney disease. The failed or intolerant therapy must include corticosteroids and at least one other drug. Candidates can be adults and children over the age of 6. Abatacept will be administered by venous infusion every 4 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Abatacept | Abatacept IV administered on Day 1, 15, 29 and then every 28 days |
| OTHER | Normal Saline | Normal Saline administer on Day 1, 15, 29 and then every 28 days |
| OTHER | D5W | Dextrose 5% in Water (D5W) administered on Day 1, 15, 29 and then every 28 days |
Timeline
- Start date
- 2016-03-09
- Primary completion
- 2020-01-28
- Completion
- 2020-01-28
- First posted
- 2015-10-30
- Last updated
- 2021-03-05
- Results posted
- 2021-03-05
Locations
27 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02592798. Inclusion in this directory is not an endorsement.