Open Actively Recruiting

A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)

About

Brief Summary

The purpose of this Phase 2 adaptive study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06730512 following multiple intravenous infusion in adult subjects with FSGS.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • Adults age 18 years and older who have a confirmed diagnosis of FSGS.
  • Estimated glomerular filtration rate (eGFR) greater than or equal to 45 ml/min/1.73 m2. If eGFR is 30 - 45 ml/min/1.73 m2, a recent biopsy (within 12 months prior to Screening) must demonstrate < 50% tubulointerstitial fibrosis.
  • Urine protein:creatinine ratio (UPCR) greater than 1.5 g/g at screening.
  • Treated with at least one but not more than 3 classes of immunosuppressants either alone or in combination, or has a contraindication to use of an immunosuppressant or is intolerant to an immunosuppressant per investigator judgment

Exclusion Criteria:

  • Diagnosis of collapsing FSGS.
  • Advanced chronic changes on renal biopsy as evidenced by greater than 50% tubulointerstitial fibrosis.
  • Body mass index (BMI) greater than 45 kg/m2.

Join this Trial

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Study Stats
Protocol No.
18-000534
Category
Nephrology
Contact
Rastogi Research
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03448692
For detailed technical eligibility, visit ClinicalTrials.gov.