Summary

for people ages 18-70 (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. In addition, the intention is to obtain an early indication of efficacy. This study may have two doses in two separate cohorts, and it will be conducted in 2 phases: an optional longitudinal observational Natural History Phase (Part A) and an adaptive Treatment Phase (Part B).

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) Glomerulosclerosis, Focal Segmental

Eligibility

You can join if…

Open to people ages 18-70

  1. Adults age between 18 and 70 years who has a confirmed diagnosis of primary FSGS.
  2. Glomerular filtration rate (eGFR) greater than or equal to 45 ml/min/1.73 m2 based on the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) formula, with a single repeat measurement permitted, as appropriate.
  3. UPCR greater than 1.5 g protein/g creatinine 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% tubulo interstitial fibrosis.
  3. Obesity (based on estimated dry weight at onset of disease prior to steroid therapy, if applicable) defined as body mass index (BMI) greater than 40 kg/m2.

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 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.
To obtain contact information for a study center near you, click here.
To obtain contact information for a study center near you, click here.
ID
NCT03448692
Phase
Phase 2
Study Type
Interventional
Last Updated