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 Sex
- 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. |
|
|
Experimental PF-06730512 Cohort 2 |
Subjects in cohort 2 will receive dose 2 IV infusion. |
|
|
Experimental PF-06730512 Cohort 3 (optional) |
Subjects in cohort 3 will receive dose 3 IV infusion. |
|
More Details
- Status
- Terminated
- Sponsor
- Pfizer