NCT02592798
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)
PHASE2
COMPLETED
NCT02592798
INTERVENTIONAL
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)
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.
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
* Male and female subjects ages ≥ 6 years
* Subjects resistant to corticosteroids, calcineurin inhibitors (cyclosporine and tacrolimus), sirolimus, mycophenolate mofetil (MMF), mycophenolic acid (MPA), or cyclophosphamide or intolerant to at least 2 of these
* UPCR ≥ 3 at screening
* FSGS or MCD confirmed by renal biopsy
* eGFR ≥ 45 for children and adults
* Concomitant use of angiotensin-converting-enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) at stable doses for at least 2 weeks or have intolerance documented in the source documents maintained at the site
Exclusion Criteria:
* Kidney diseases other than FSGS or MCD
* Collapsing FSGS
* Systemic lupus erythematosus
* Diabetes mellitus, both type 1 and type 2
* Clinically significant congestive heart failure
* Post renal transplantation, including relapsing post-transplant FSGS
* Body mass index (BMI): > 40 in subjects ≥ 18 years of age and ≥ 99% percentile for subjects < 18 years of age
Other protocol defined inclusion/exclusion criteria may apply
Nephrotic Syndrome
Focal Segmental Glomerulosclerosis
Minimal Change Disease
- TREATMENT
-
- Type: DRUG
- Name: Abatacept
- Description: Abatacept IV administered on Day 1, 15, 29 and then every 28 days
- Arm Group Labels: Abatacept
-
- Type: OTHER
- Name: Normal Saline
- Description: Normal Saline administer on Day 1, 15, 29 and then every 28 days
- Arm Group Labels: Placebo
-
- Type: OTHER
- Name: D5W
- Description: Dextrose 5% in Water (D5W) administered on Day 1, 15, 29 and then every 28 days
- Arm Group Labels: Placebo
- Bristol-Myers Squibb