Trial · NCT03762850
A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy
NCT03762850, Phase 3, Completed, Travere Therapeutics, Inc.; results first posted 2024-07-03
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy. Trials, record NCT03762850. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03762850
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy
- NCT number
- NCT03762850
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 406 participants, actual
- Lead sponsor
- Travere Therapeutics, Inc.
- Conditions
- Immunoglobulin A Nephropathy
- Interventions
- sparsentan, irbesartan, Dapagliflozin
- First posted
- 2018-12-04
- Last updated
- 2026-10-14
- Other registries' IDs
- eudract:2017-004605-41
- Results first posted
- 2024-07-03
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in the Urine Protein/Creatinine (UP/C) at Week 36 | Baseline (Day 1) and at Week 36 | 24-hour urine sample was collected for analysis of UP/C via a mixed-model repeated-measures (MMRM) analysis. Missing responses were imputed prior to analysis using multiple imputation. Change from Baseline during the double-blind period in UP/C on the log scale was the dependent variable. Log Baseline UP/C was included as a covariate along with fixed effects for randomized treatment, time (ie, nominal visit in weeks), randomized treatment-by-time interaction, and randomization strata with participants as random effect. Estimates in log scale were back transformed. Baseline was defined as the last non-missing observation on or prior to the start of the dosing. Using Rubin's approach, estimated treatment effects are combined across all imputations to obtain overall estimates. |
| Secondary | Total Slope of Estimated Glomerular Filtration Rate (eGFR) Over a 110-week Period | From Day 1 to Week 110 | The rate of change in eGFR from Day 1 to Week 110 (ie, over 110 weeks) was analyzed via a mixed-model random coefficients analysis. Missing responses were imputed prior to analysis using multiple imputation. Fixed effects for randomized treatment, Baseline eGFR, time (in weeks), randomized treatment-by-time interaction, and randomization strata were included. In addition, the model also included a random intercept and random slope for each participant. Using Rubin's approach, the estimated treatment effects are combined across all imputations to obtain the overall estimates. |
| Secondary | Annualized Slope of eGFR Following the Initial Acute Effect of Randomized Treatment (Chronic Slope) | From Week 6 to Week 110 post randomization | The rate of change in eGFR from Week 6 to Week 110 (ie, over 104 weeks following the initial acute effect of randomized therapy) was analyzed via a mixed-model random coefficients analysis. Missing responses were imputed prior to analysis using multiple imputation. Fixed effects for randomized treatment, Baseline eGFR, time (in weeks), randomized treatment-by-time interaction, and randomization strata were included. In addition, the model also included a random intercept and random slope for each participant. Using Rubin's approach, the estimated treatment effects are combined across all imputations to obtain the overall estimates. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in the Urine Protein/Creatinine (UP/C) at Week 36 | Baseline (Day 1) and at Week 36 | The Primary Analysis Set (PAS) is the subset of the Full Analysis Set at the time of the data extraction for primary analysis. Participants in the PAS were analyzed according to randomized treatment assignment. | Percent change | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | Total Slope of Estimated Glomerular Filtration Rate (eGFR) Over a 110-week Period | From Day 1 to Week 110 | Full Analysis Set. | milliliters/minute/1.73square meter/year | LEAST_SQUARES_MEAN |
| SECONDARY | Annualized Slope of eGFR Following the Initial Acute Effect of Randomized Treatment (Chronic Slope) | From Week 6 to Week 110 post randomization | Full Analysis Set. | milliliters/minute/1.73square meter/year | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in the Urine Protein/Creatinine (UP/C) at Week 36 | Sparsentan | -49.77 | 95% Confidence Interval -54.98 to -43.95 | Percent change | |
| Percent Change From Baseline in the Urine Protein/Creatinine (UP/C) at Week 36 | Irbesartan | -15.05 | 95% Confidence Interval -23.72 to -5.39 | Percent change | |
| Total Slope of Estimated Glomerular Filtration Rate (eGFR) Over a 110-week Period | Sparsentan | -2.9 | 95% Confidence Interval -3.58 to -2.24 | milliliters/minute/1.73square meter/year | |
| Total Slope of Estimated Glomerular Filtration Rate (eGFR) Over a 110-week Period | Irbesartan | -3.9 | 95% Confidence Interval -4.59 to -3.13 | milliliters/minute/1.73square meter/year | |
| Annualized Slope of eGFR Following the Initial Acute Effect of Randomized Treatment (Chronic Slope) | Sparsentan | -2.7 | 95% Confidence Interval -3.43 to -2.05 | milliliters/minute/1.73square meter/year | |
| Annualized Slope of eGFR Following the Initial Acute Effect of Randomized Treatment (Chronic Slope) | Irbesartan | -3.8 | 95% Confidence Interval -4.60 to -3.07 | milliliters/minute/1.73square meter/year |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sparsentan | 203 | |
| Overall Study | STARTED | Irbesartan | 203 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Sparsentan | 202 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Irbesartan | 202 | |
| Overall Study | COMPLETED | Sparsentan | 199 | |
| Overall Study | COMPLETED | Irbesartan | 191 | |
| Overall Study | NOT COMPLETED | Sparsentan | 4 | |
| Overall Study | NOT COMPLETED | Irbesartan | 12 |
Source ClinicalTrials.gov
Adverse events248
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 | 53 | 202 | |
| other | COVID-19 | Infections and infestations | Irbesartan | 46 | 202 | |
| other | Upper respiratory tract infection | Infections and infestations | Sparsentan | 18 | 202 | |
| other | Upper respiratory tract infection | Infections and infestations | Irbesartan | 18 | 202 | |
| other | Nasopharyngitis | Infections and infestations | Sparsentan | 15 | 202 | |
| other | Nasopharyngitis | Infections and infestations | Irbesartan | 16 | 202 | |
| other | Urinary tract infection | Infections and infestations | Sparsentan | 7 | 202 | |
| other | Urinary tract infection | Infections and infestations | Irbesartan | 12 | 202 | |
| other | Hyperkalaemia | Metabolism and nutrition disorders | Sparsentan | 32 | 202 | |
| other | Hyperkalaemia | Metabolism and nutrition disorders | Irbesartan | 26 | 202 |
1 to 10 of 248Source ClinicalTrials.gov
See all 248 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sparsentan | 0 | 202 |
| Total, all-cause mortality | Irbesartan | 1 | 202 |
| Total, other adverse events | Sparsentan | 187 | 202 |
| Total, other adverse events | Irbesartan | 177 | 202 |
| Total, serious adverse events | Sparsentan | 75 | 202 |
| Total, serious adverse events | Irbesartan | 71 | 202 |
Source ClinicalTrials.gov
Papers5
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/NCT03762850
GET https://conductscience.org/api/trials/v1/NCT03762850/events?page=2