Trial · NCT01613118
Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis
NCT01613118, Phase 2, Completed, Travere Therapeutics, Inc.; results first posted 2021-07-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis. Trials, record NCT01613118. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01613118
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis
- NCT number
- NCT01613118
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 109 participants, actual
- Lead sponsor
- Travere Therapeutics, Inc.
- Conditions
- Focal Segmental Glomerulosclerosis
- Interventions
- RE-021 (Sparsentan), Irbesartan
- First posted
- 2012-06-06
- Last updated
- 2025-05-15
- Results first posted
- 2021-07-27
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Urine Protein/Creatinine (Up/C) | 8 weeks | Primary efficacy objective is to determine the change in UP/C in FSGS patients receiving RE-021 (Sparsentan) from baseline to 8 weeks over a range of dose levels compared to treatment with irbesartan as active control. |
| Secondary | Percentage of Patients Achieving FSGS Partial Remission Endpoint (FPRE) | 8 weeks | The secondary efficacy endpoint is the proportion of FSGS patients achieving FPRE (experiencing a UP/C ratio ≤1.5 g/g and \>40% reduction from baseline in Up/C) at Week 8 over a range of dose levels compared to treatment with irbesartan as active control. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Urine Protein/Creatinine (Up/C) | 8 weeks | Efficacy evaluable set | percent change | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Patients Achieving FSGS Partial Remission Endpoint (FPRE) | 8 weeks | Efficacy evaluable set. The sparsentan arms were compared to irbesartan in several different combinations that were defined in the study's Statistical Analysis Plan. | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Urine Protein/Creatinine (Up/C) | RE-021 (Sparsentan) 200, 400, 800 mg Pooled | -44.8 | 95% Confidence Interval -52.7 to -35.7 | percent change | |
| Percent Change in Urine Protein/Creatinine (Up/C) | Irbesartan 300 mg Pooled | -18.5 | 95% Confidence Interval -34.6 to 1.7 | percent change | |
| Percent Change in Urine Protein/Creatinine (Up/C) | RE-021 (Sparsentan) 400 and 800 mg Pooled | -47.4 | 95% Confidence Interval -56.3 to -36.9 | percent change | |
| Percent Change in Urine Protein/Creatinine (Up/C) | RE-021 (Sparsentan) 200mg | -33.1 | 95% Confidence Interval -49.3 to -11.6 | percent change | |
| Percent Change in Urine Protein/Creatinine (Up/C) | RE-021 (Sparsentan) 400mg | -52.7 | 95% Confidence Interval -64.3 to -37.2 | percent change | |
| Percent Change in Urine Protein/Creatinine (Up/C) | RE-021 (Sparsentan) 800mg | -41.3 | 95% Confidence Interval -54.4 to -24.4 | percent change | |
| Percentage of Patients Achieving FSGS Partial Remission Endpoint (FPRE) | RE-021 (Sparsentan) 200, 400, 800 mg Pooled | 28.13 | percentage of patients | ||
| Percentage of Patients Achieving FSGS Partial Remission Endpoint (FPRE) | Irbesartan 300 mg Pooled | 9.38 | percentage of patients | ||
| Percentage of Patients Achieving FSGS Partial Remission Endpoint (FPRE) | RE-021 (Sparsentan) 400 and 800 mg Pooled | 31.37 | percentage of patients | ||
| Percentage of Patients Achieving FSGS Partial Remission Endpoint (FPRE) | RE-021 (Sparsentan) 200 mg | 15.38 | percentage of patients |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow35
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind | STARTED | RE-021 (Sparsentan) 200 mg - Double-Blind Period | 13 | |
| Double-blind | STARTED | RE-021 (Sparsentan) 400 mg - Double-Blind Period | 26 | |
| Double-blind | STARTED | RE-021 (Sparsentan) 800 mg - Double-Blind Period | 34 | |
| Double-blind | STARTED | Irbesartan 300 mg - Double-Blind Period | 36 | |
| Double-blind | STARTED | RE-021 (Sparsentan) - Open-Label Extension Period | 0 | |
| Double-blind | COMPLETED | RE-021 (Sparsentan) 200 mg - Double-Blind Period | 13 | |
| Double-blind | COMPLETED | RE-021 (Sparsentan) 400 mg - Double-Blind Period | 23 | |
| Double-blind | COMPLETED | RE-021 (Sparsentan) 800 mg - Double-Blind Period | 32 | |
| Double-blind | COMPLETED | Irbesartan 300 mg - Double-Blind Period | 35 | |
| Double-blind | COMPLETED | RE-021 (Sparsentan) - Open-Label Extension Period | 0 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 participant flowAdverse events705
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | RE-021 (Sparsentan) 200 mg - Double-Blind Period | 0 | 13 | 0 |
| other | COVID-19 | Infections and infestations | RE-021 (Sparsentan) 400 mg - Double-Blind Period | 0 | 26 | 0 |
| other | COVID-19 | Infections and infestations | RE-021 (Sparsentan) 800 mg - Double-Blind Period | 0 | 34 | 0 |
| other | COVID-19 | Infections and infestations | Irbesartan 300 mg - Double-Blind Period | 0 | 36 | 0 |
| other | COVID-19 | Infections and infestations | All Sparsentan (Double-Blind and Open-Label Extension) | 17 | 108 | 19 |
| other | Upper respiratory tract infection | Infections and infestations | RE-021 (Sparsentan) 200 mg - Double-Blind Period | 0 | 13 | 0 |
| other | Upper respiratory tract infection | Infections and infestations | RE-021 (Sparsentan) 400 mg - Double-Blind Period | 0 | 26 | 0 |
| other | Upper respiratory tract infection | Infections and infestations | RE-021 (Sparsentan) 800 mg - Double-Blind Period | 2 | 34 | 3 |
| other | Upper respiratory tract infection | Infections and infestations | Irbesartan 300 mg - Double-Blind Period | 2 | 36 | 2 |
| other | Upper respiratory tract infection | Infections and infestations | All Sparsentan (Double-Blind and Open-Label Extension) | 17 | 108 | 43 |
1 to 10 of 705Source ClinicalTrials.gov
See all 705 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RE-021 (Sparsentan) 200 mg - Double-Blind Period | 0 | 13 |
| Total, all-cause mortality | RE-021 (Sparsentan) 400 mg - Double-Blind Period | 0 | 26 |
| Total, all-cause mortality | RE-021 (Sparsentan) 800 mg - Double-Blind Period | 0 | 34 |
| Total, all-cause mortality | Irbesartan 300 mg - Double-Blind Period | 0 | 36 |
| Total, all-cause mortality | All Sparsentan (Double-Blind and Open-Label Extension) | 0 | 108 |
| Total, other adverse events | RE-021 (Sparsentan) 200 mg - Double-Blind Period | 11 | 13 |
| Total, other adverse events | RE-021 (Sparsentan) 400 mg - Double-Blind Period | 17 | 26 |
| Total, other adverse events | RE-021 (Sparsentan) 800 mg - Double-Blind Period | 27 | 34 |
| Total, other adverse events | Irbesartan 300 mg - Double-Blind Period | 26 | 36 |
| Total, other adverse events | All Sparsentan (Double-Blind and Open-Label Extension) | 104 | 108 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01613118
GET https://conductscience.org/api/trials/v1/NCT01613118/flow?page=2