Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion

Description

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 primary FSGS.

Official Title

A PHASE 2, 12-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH PRIMARY FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)

Keywords

Focal Segmental Glomerulosclerosis (FSGS) Proteinuria Glomerulosclerosis, Focal Segmental

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Adults age 18 years and older who has a confirmed diagnosis of primary FSGS.
  2. 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.
  3. Urine protein:creatinine ratio (UPCR) greater than 1.5 g/g at screening.

You CAN'T join if...

  1. Diagnosis of secondary and/or collapsing FSGS.
  2. Advanced chronic changes on renal biopsy as evidenced by greater than 50% tubulointerstitial fibrosis.
  3. Body mass index (BMI) greater than 40 kg/m2.

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States
  • Clinical and Translation Research Unit accepting new patients
    Palo Alto California 94304 United States
  • Stanford University-Nephrology Division accepting new patients
    Palo Alto California 94304 United States
  • Stanford Health Care Investigational Pharmacy accepting new patients
    Stanford California 94305 United States
  • Stanford University accepting new patients
    Stanford California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT03448692
Phase
Phase 2
Study Type
Interventional
Last Updated