Trial To Evaluate PF-06730512 In Adults With Primary Focal Segmental Glomerulosclerosis
| Status: | Recruiting |
|---|---|
| Conditions: | Nephrology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 3/30/2019 |
| Start Date: | October 15, 2018 |
| End Date: | March 16, 2021 |
| Contact: | Pfizer CT.gov Call Center |
| Email: | ClinicalTrials.gov_Inquiries@pfizer.com |
| Phone: | 1-800-718-1021 |
A PHASE 2, 12-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 PRIMARY FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)
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 primary FSGS. In addition, the intention is to obtain an early indication of efficacy.
This study may have two doses in two separate cohorts, and it will be conducted in 2 phases:
an optional longitudinal observational Natural History Phase (Part A) and an adaptive
Treatment Phase (Part B).
and pharmacokinetics of PF-06730512 following multiple intravenous infusion in adult subjects
with primary FSGS. In addition, the intention is to obtain an early indication of efficacy.
This study may have two doses in two separate cohorts, and it will be conducted in 2 phases:
an optional longitudinal observational Natural History Phase (Part A) and an adaptive
Treatment Phase (Part B).
Inclusion Criteria:
1. Adults age between 18 and 70 years who has a confirmed diagnosis of primary FSGS.
2. Glomerular filtration rate (eGFR) greater than or equal to 45 ml/min/1.73 m2 based on
the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) formula, with a single
repeat measurement permitted, as appropriate.
3. UPCR greater than 1.5 g protein/g creatinine at screening.
Exclusion Criteria:
1. Diagnosis of secondary and/or collapsing FSGS.
2. Advanced chronic changes on renal biopsy as evidenced by greater than 50% tubulo
interstitial fibrosis.
3. Obesity (based on estimated dry weight at onset of disease prior to steroid therapy,
if applicable) defined as body mass index (BMI) greater than 40 kg/m2.
We found this trial at
26
sites
1719 East 19th Avenue
Denver, Colorado 80218
Denver, Colorado 80218
(303) 839-6000
Presbyterian - St. Luke's Medical Center Presbyterian/St. Luke's Medical Center and the Rocky Mountain Hospital...
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Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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