Trial · NCT03493685
Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)
NCT03493685, Phase 3, Completed, Travere Therapeutics, Inc.; results first posted 2024-04-30
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS). Trials, record NCT03493685. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03493685
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)
- NCT number
- NCT03493685
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 371 participants, actual
- Lead sponsor
- Travere Therapeutics, Inc.
- Conditions
- Focal Segmental Glomerulosclerosis
- Interventions
- sparsentan, Irbesartan
- First posted
- 2018-04-10
- Last updated
- 2026-04-17
- Results first posted
- 2024-04-30
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Slope of Estimated Glomerular Filtration Rate (eGFR) | From Day 1 to Week 108 | The total eGFR slope over 2 years, defined as the slope of eGFR following initiation of randomized treatment (ie, Day 1 to Week 108). Estimates are calculated from a mixed-effects model with treatment, Baseline eGFR, analysis visit, treatment-by-analysis visit, randomization stratification factors as fixed effects, and intercept and slope for each participant as a random effect. |
| Primary | Percentage of Participants Achieving FSGS Partial Remission Endpoint (FPRE) | Week 36 | Percentage of participants achieving FPRE, defined as urine protein-to-creatinine ratio (UP/C) ≤1.5 grams/gram (g/g) (170 milligrams per millimoles \[mg/mmol\]) and a \>40% reduction from Baseline was analyzed using a generalized linear model to model probability of achieving FPRE. Missing responses were imputed prior to analysis using multiple imputation. A generalized linear model with appropriate link function was implemented with Baseline log (UP/C), treatment, analysis visit, treatment by analysis visit interaction, and randomization strata as fixed effects. For estimates of probability of achieving FPRE, risk difference, and odds ratio, binomial distribution with logit link was used. For relative risk, Poisson distribution with log link was used. Using Rubin's approach, estimated treatment effects are combined across all imputations to obtain overall estimates for probabilities. |
| Secondary | Slope of eGFR Following the Initial Acute Effect of Randomized Treatment | From Week 6 to Week 108 | The chronic eGFR slope over 2 years, defined as the slope of eGFR following the initial acute effect of randomized treatment (ie, Week 6 to Week 108). Estimates were calculated from a mixed-effects model with linear spline (ie, change point at Week 6), which included treatment, Baseline eGFR, time from Baseline (TFB) (weeks), time from change point (TFCP) (weeks), treatment-by-TFB and treatment-by-TFCP interactions, and randomization stratification factors as fixed effects, intercept and slopes as random effects. The slope difference was tested by the null hypothesis that the sum of the treatment-by-TFB and treatment-by-TFCP interactions = 0. |
| Secondary | Change From Baseline in eGFR to 4 Weeks Post-cessation of Randomized Treatment | Baseline (Day 1) to Week 112 | The change from Baseline to 4 weeks post-cessation of randomized treatment (Week 112) was analyzed via an analysis of covariance (ANCOVA) model on the natural log(eGFR) with treatment, Baseline eGFR, and randomization strata as fixed effects. Only participants who completed the 108-week treatment period were included. Estimated LS Mean and 95% CI are converted to percentages as follows: \[exponential (LS mean change from baseline in natural log(eGFR)) minus 1\] multiplied by 100. Baseline (Day 1) was defined as the last non-missing assessment prior to and including the first administration of study medication in the study including unscheduled assessments. Percent change from Baseline was calculated as "\[(Post Baseline minus Baseline value)/ Baseline value\] multiplied by 100. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Slope of Estimated Glomerular Filtration Rate (eGFR) | From Day 1 to Week 108 | Full Analysis Set. | milliliters/minute/1.73square meter/year | LEAST_SQUARES_MEAN |
| PRIMARY | Percentage of Participants Achieving FSGS Partial Remission Endpoint (FPRE) | Week 36 | Full Analysis Set. | Percentage of participants | NUMBER |
| SECONDARY | Slope of eGFR Following the Initial Acute Effect of Randomized Treatment | From Week 6 to Week 108 | Full Analysis Set. | milliliters/minute/1.73square meter/year | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in eGFR to 4 Weeks Post-cessation of Randomized Treatment | Baseline (Day 1) to Week 112 | Full Analysis Set (Patients who Completed Blinded Treatment). Only those participants with data available at specified time points have been presented. | milliliters/minute/1.73square meter | GEOMETRIC_LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Slope of Estimated Glomerular Filtration Rate (eGFR) | Sparsentan | -5.4 | 95% Confidence Interval -6.89 to -3.93 | milliliters/minute/1.73square meter/year | |
| Slope of Estimated Glomerular Filtration Rate (eGFR) | Irbesartan | -5.7 | 95% Confidence Interval -7.20 to -4.29 | milliliters/minute/1.73square meter/year | |
| Percentage of Participants Achieving FSGS Partial Remission Endpoint (FPRE) | Sparsentan | 42.0 | Percentage of participants | ||
| Percentage of Participants Achieving FSGS Partial Remission Endpoint (FPRE) | Irbesartan | 26.0 | Percentage of participants | ||
| Slope of eGFR Following the Initial Acute Effect of Randomized Treatment | Sparsentan | -4.8 | 95% Confidence Interval -6.34 to -3.27 | milliliters/minute/1.73square meter/year | |
| Slope of eGFR Following the Initial Acute Effect of Randomized Treatment | Irbesartan | -5.7 | 95% Confidence Interval -7.20 to -4.18 | milliliters/minute/1.73square meter/year | |
| Change From Baseline in eGFR to 4 Weeks Post-cessation of Randomized Treatment | Sparsentan | -10.4 | 95% Confidence Interval -12.60 to -8.13 | milliliters/minute/1.73square meter | |
| Change From Baseline in eGFR to 4 Weeks Post-cessation of Randomized Treatment | Irbesartan | -12.1 | 95% Confidence Interval -14.36 to -9.91 | milliliters/minute/1.73square meter |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sparsentan | 184 | |
| Overall Study | STARTED | Irbesartan | 187 | |
| Overall Study | COMPLETED | Sparsentan | 168 | |
| Overall Study | COMPLETED | Irbesartan | 171 | |
| Overall Study | NOT COMPLETED | Sparsentan | 16 | |
| Overall Study | NOT COMPLETED | Irbesartan | 16 |
Source ClinicalTrials.gov
Adverse events370
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 | Sparsentan | 41 | 184 | |
| other | COVID-19 | Infections and infestations | Irbesartan | 50 | 187 | |
| other | Upper respiratory tract infection | Infections and infestations | Sparsentan | 10 | 184 | |
| other | Upper respiratory tract infection | Infections and infestations | Irbesartan | 16 | 187 | |
| other | Urinary tract infection | Infections and infestations | Sparsentan | 9 | 184 | |
| other | Urinary tract infection | Infections and infestations | Irbesartan | 17 | 187 | |
| other | Nasopharyngitis | Infections and infestations | Sparsentan | 11 | 184 | |
| other | Nasopharyngitis | Infections and infestations | Irbesartan | 9 | 187 | |
| other | Influenza | Infections and infestations | Sparsentan | 6 | 184 | |
| other | Influenza | Infections and infestations | Irbesartan | 12 | 187 |
1 to 10 of 370Source ClinicalTrials.gov
See all 370 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sparsentan | 4 | 184 |
| Total, all-cause mortality | Irbesartan | 3 | 187 |
| Total, other adverse events | Sparsentan | 172 | 184 |
| Total, other adverse events | Irbesartan | 174 | 187 |
| Total, serious adverse events | Sparsentan | 68 | 184 |
| Total, serious adverse events | Irbesartan | 82 | 187 |
Source ClinicalTrials.gov
Papers6
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sparsentan vs Irbesartan: deaths from any cause | Trial comparisons |
| Sparsentan vs Irbesartan: serious adverse events | Trial comparisons |
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/NCT03493685
GET https://conductscience.org/api/trials/v1/NCT03493685/events?page=2