Clinical Trial: 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)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase II Randomized, Placebo-Controlled, Double-Blind, Parallel Arms With Switchover, Pilot Study to Evaluate the Efficacy and Safety of Intravenous Abatacept in Treatment Resistant Nephrotic Syndro

Brief 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.

Detailed Summary:
Sponsor: Bristol-Myers Squibb

Current Primary Outcome: Proportion of subjects in Renal Response at Day 113 [ Time Frame: Day 113 ]

Proportion of subjects in Renal Response (reduction in baseline UPCR of ≥ 50% and to less than 3 with no worsening of baseline estimated glomerular filtration rate (eGFR: normal or ≥ 75% baseline if below normal at baseline)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mean change from baseline in Urine Protein to Creatinine Ratio (UPCR) at Day 113 [ Time Frame: Day 113 ]
  • Mean change from baseline in serum albumin at Day 113 [ Time Frame: Day 113 ]
  • Proportion of subjects achieving complete remission [ Time Frame: Day 113 ]
    Proportion of subjects achieving complete remission (UPCR ≤ 0.3 with Estimated glomerular filtration rate (eGFR): normal or ≥ 75% baseline if below normal at baseline) at Day 113
  • Mean change in PROMIS measures [ Time Frame: Approximately 113 days ]
    Patient Reported Outcomes Measurement Information System (PROMIS)
  • Safety measured by incidence, potential significance and clinical importance of AEs, SAEs, as determined by medical review of AE reports, vital sign measurements, ECGs and results of physical examination and laboratory tests [ Time Frame: Approximately 113 days ]
    Adverse Event (AE), Serious adverse event (SAE)
  • Proportion of subjects with positive antibody response relative to baseline over time [ Time Frame: Approximately 113 days ]


Original Secondary Outcome: Same as current

Information By: Bristol-Myers Squibb

Dates:
Date Received: October 29, 2015
Date Started: March 2016
Date Completion: June 2020
Last Updated: April 17, 2017
Last Verified: February 2017