Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis
Public ClinicalTrials.gov record NCT01613118. 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
Efficacy and Safety of Sparsentan (RE-021), a Dual Endothelin Receptor and Angiotensin Receptor Blocker, in Patients With Focal Segmental Glomerulosclerosis (FSGS): a Randomized, Double-Blind, Active-Control, Dose-Escalation Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will investigate whether RE-021 (Sparsentan), a selective dual-acting receptor antagonist with affinity for endothelin (A type) and angiotensin II receptors (Type 1), is safe and effective in treating patients with focal segmental glomerulosclerosis (FSGS).
Study identification
- NCT ID
- NCT01613118
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 109 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 8 Years to 75 Years
- 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
- Mar 2014 (Actual)
- Primary completion
- Jun 2016 (Actual)
- Completion
- Mar 25, 2024 (Actual)
- Last update posted
- May 15, 2025
2014 – 2024
United States locations
- U.S. sites
- 28
- U.S. states
- 17
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Balboa Nephrology Medical Group | San Diego | California | 92123 | — |
| Los Angeles Biomedical Research Institute | Torrance | California | 90502 | — |
| Colorado Kidney Care | Denver | Colorado | 80230 | — |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | — |
| Miami Children's Hospital | Miami | Florida | 33155 | — |
| University of Iowa Children's Hospital | Iowa City | Iowa | 52242 | — |
| Renal and Transplant Associates of New England, PC | Springfield | Massachusetts | 01107 | — |
| University of Minnesota | Minneapolis | Minnesota | 55454 | — |
| The Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| NYU Langone Medical Center | New York | New York | 10016 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| SUNY Stony Brook Hospital | Stony Brook | New York | 11794-8111 | — |
| UNC Kidney Center, Pediatrics | Chapel Hill | North Carolina | 27599 | — |
| University North Carolina (UNC) Kidney Center | Chapel Hill | North Carolina | 27599 | — |
| Akron Nephrology Associates | Akron | Ohio | 44302 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Unversity of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Northeast Clinical Research Center | Bethlehem | Pennsylvania | 18017 | — |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Temple University School of Medicine | Philadelphia | Pennsylvania | 19140 | — |
| University of Pennsylvania, Perelman School of Medicine | Philadelphia | Pennsylvania | 19140 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Clinical Advancement Center | San Antonio | Texas | 78215 | — |
| Southern Utah Kidney and Hypertension Center | St. George | Utah | 84790 | — |
| University of Washington | Seattle | Washington | 98195 | — |
| Catholic Health Initiatives Franciscan | Tacoma | Washington | 98405 | — |
| Marshfield Clinic Research Foundation | Marshfield | Wisconsin | 54449 | — |
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 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01613118, 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 May 15, 2025 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01613118 live on ClinicalTrials.gov.