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)
Condition: Nephrotic Syndrome; Focal Segmental Glomerulosclerosis; Minimal Change Disease
MeSH terms: Nephrotic Syndrome; Nephrosis; Glomerulosclerosis, Focal Segmental; Nephrosis, Lipoid; Syndrome
Intervention: Abatacept; Normal Saline; D5W
Intervention description: Abatacept IV administered on Day 1, 15, 29 and then every 28 days; Normal Saline administer on Day 1, 15, 29 and then every 28 days; Dextrose 5% in Water (D5W) administered on Day 1, 15, 29 and then every 28 days
Intervention MeSH terms: Abatacept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

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        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