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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Focal Segmental Glomerulosclerosis (FSGS)

Treatments: Drug: PF-06730512

Study type: Interventional

Funder types: Industry

Identifiers

NCT03448692

C0221002

ROBO2 (Other Identifier)

2019-003607-35 (EudraCT Number)

PODO (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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47 participants in 3 patient groups

PF-06730512 Cohort 1

Experimental group

Description:

Subjects in cohort 1 will receive dose 1 Intravenous (IV) infusion.

Treatment:

Drug: PF-06730512

PF-06730512 Cohort 2

Experimental group

Description:

Subjects in cohort 2 will receive dose 2 IV infusion.

Treatment:

Drug: PF-06730512

PF-06730512 Cohort 3 (optional)

Experimental group

Description:

Subjects in cohort 3 will receive dose 3 IV infusion.

Treatment:

Drug: PF-06730512