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

  • STATUS
    Recruiting
  • End date
    Feb 5, 2024
  • participants needed
    44
  • sponsor
    Pfizer
Updated on 14 August 2021
immunosuppressive agents
glomerular filtration rate
total protein
tubulointerstitial fibrosis
focal segmental glomerulosclerosis

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.

Details
Condition Focal glomerulosclerosis, Glomerulonephritis, Focal Segmental Glomerulosclerosis
Treatment PF-06730512
Clinical Study IdentifierNCT03448692
SponsorPfizer
Last Modified on14 August 2021

Eligibility

Yes No Not Sure

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
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