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)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02592798
• Date of registration: 29/10/2015
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: 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)
• Scientific title: 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)
• Date of first enrolment: March 1, 2016
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02592798
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Bristol Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

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



Age minimum: 6 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Minimal Change Disease

Focal Segmental Glomerulosclerosis

Nephrotic Syndrome

Intervention(s)

Drug: Abatacept

Other: D5W

Other: Normal Saline

Primary Outcome(s)

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

Secondary Outcome(s)

Mean change from baseline in Urine Protein to Creatinine Ratio (UPCR) at Day 113 [Time Frame: Day 113]

Safety measured by incidence, potential significance and clinical importance of AEs, SAEs, as determined by medical review of AE reports, vital sign measurements and results of physical examination and laboratory tests [Time Frame: 16 months]

Proportion of subjects achieving complete remission [Time Frame: Day 113]

Proportion of subjects with positive antibody response relative to baseline over time [Time Frame: 16 months]

Mean change in PROMIS measures [Time Frame: Day 113]

Mean change from baseline in serum albumin at Day 113 [Time Frame: Day 113]

Secondary ID(s)

IM101-566

2015-005450-36

Source(s) of Monetary Support

Please refer to primary and secondary sponsors