Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
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 infusions in adult subjects with FSGS.

Official Title

A PHASE 2, 24-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 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 have a confirmed biopsy diagnosis of 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.
  4. 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.

You CAN'T join if...

  1. Diagnosis of collapsing FSGS.
  2. Advanced chronic changes on renal biopsy as evidenced by greater than 50% tubulointerstitial fibrosis.
  3. Organ transplant.
  4. History of malignancy, with the exception of basal or squamous cell carcinoma that has been treated and fully resolved for a minimum of 5 years.
  5. Body mass index (BMI) greater than 45 kg/m2.
  6. Subjects with a history of prior treatment with or use of interferon, lithium, pamidronate, mTOR inhibitors (eg, sirolimus), testosterone/anabolic steroids, anthracycline (eg, doxorubicin), heroin.

Locations

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

Details

Status
in progress, not 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 Focal Segmental Glomerulosclerosis Research Study
Study Type
Interventional
Participants
At least 33 people participating
Last Updated