A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)
Public ClinicalTrials.gov record NCT01665391. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Multicenter, Double-Blind, Parallel Dosing, Randomized Study of Fresolimumab or Placebo in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objectives of this trial are as follows: * to compare the achievement of a partial remission (PR) or complete remission (CR) in urinary protein: creatinine ratio (Up/c ratio) in patients treated with fresolimumab versus placebo * to compare the safety profile of patients treated with fresolimumab versus placebo The secondary objectives are as follows: * To compare the reduction in proteinuria in patients treated with fresolimumab versus placebo * To evaluate fresolimumab dose-dependent reduction in proteinuria * To compare the change in renal function (estimated glomerular filtration rate \[eGFR\]) in patients treated with fresolimumab versus placebo * To evaluate the multiple-dose pharmacokinetics of fresolimumab
Study identification
- NCT ID
- NCT01665391
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 36 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2012 (Type not available)
- Primary completion
- Jun 2014 (Actual)
- Completion
- Nov 2014 (Actual)
- Last update posted
- Aug 26, 2015
2012 – 2014
United States locations
- U.S. sites
- 21
- U.S. states
- 15
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 4008 | Birmingham | Alabama | 35205 | — |
| Investigational Site Number 4029 | Phoenix | Arizona | 85032 | — |
| Investigational Site Number 4009 | San Francisco | California | 94143 | — |
| Investigational Site Number 4023 | Stanford | California | 94305 | — |
| Investigational Site Number 4005 | Atlanta | Georgia | 30322 | — |
| Investigational Site Number 4019 | Springfield | Illinois | 01107 | — |
| Investigational Site Number 4004 | Baltimore | Maryland | 21287 | — |
| Investigational Site Number 4002 | Bethesda | Maryland | 20892 | — |
| Investigational Site Number 4022 | Boston | Massachusetts | 02115 | — |
| Investigational Site Number 4012 | Ann Arbor | Michigan | 48109 | — |
| Investigational Site Number 4025 | Detroit | Michigan | 48202 | — |
| Investigational Site Number 4006 | Rochester | Minnesota | 55905 | — |
| Investigational Site Number 4024 | St Louis | Missouri | 63110 | — |
| Investigational Site Number 4016 | New York | New York | 10029 | — |
| Investigational Site Number 4003 | New York | New York | 10032 | — |
| Investigational Site Number 4014 | Rosedale | New York | 11422 | — |
| Investigational Site Number 4018 | Philadelphia | Pennsylvania | 19104 | — |
| Investigational Site Number 4001 | Chattanooga | Tennessee | 37404 | — |
| Investigational Site Number 4020 | Dallas | Texas | 75390 | — |
| Investigational Site Number 4027 | Houston | Texas | 77030 | — |
| Investigational Site Number 4013 | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01665391, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 26, 2015 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01665391 live on ClinicalTrials.gov.