UAB - Center for Clinical and Translational Science

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

Purpose

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.

Condition

Focal Segmental Glomerulosclerosis (FSGS)

Eligibility

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

Inclusion Criteria

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.

Exclusion Criteria

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.

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

Arm	Description	Assigned 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. Subjects in cohort 3 will receive Dose 3 IV infusion.
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. Subjects in cohort 3 will receive Dose 3 IV infusion.
Experimental PF-06730512 Cohort 3 (optional)	Subjects in cohort 3 will receive dose 3 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. Subjects in cohort 3 will receive Dose 3 IV infusion.

More Details

Status: Terminated
Sponsor: Pfizer

Study Contact

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.