Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Adults age 18 years and older who have a confirmed 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

Exclusion Criteria

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)
Masking Description
Open label

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
PF-06730512 Cohort 1
Subjects in cohort 1 will receive dose 1 Intravenous (IV) infusion.
  • Drug: PF-06730512
    Subjects in cohort 1 will receive Dose 1 Intravenous infusion (IV). Subjects in cohort 2 will receive Dose 2 IV.
Experimental
PF-06730512 Cohort 2
Subjects in cohort 2 will receive dose 2 IV infusion.
  • Drug: PF-06730512
    Subjects in cohort 1 will receive Dose 1 Intravenous infusion (IV). Subjects in cohort 2 will receive Dose 2 IV.

Recruiting Locations

UAB Nephrology Research Clinic at Paula Building
Birmingham, Alabama 35294

Clinical Research Unit at UAB Hospital
Birmingham, Alabama 35294

Investigational Drug Service Pharmacy UAB Hosptial
Birmingham, Alabama 35249

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.