Trial · NCT05856760
A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgAN
NCT05856760, Phase 2, Completed, Travere Therapeutics, Inc.; results first posted 2025-11-20
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgAN. Trials, record NCT05856760. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05856760
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgAN
- NCT number
- NCT05856760
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- Travere Therapeutics, Inc.
- Conditions
- Immunoglobulin A Nephropathy
- Interventions
- Sparsentan
- First posted
- 2023-05-12
- Last updated
- 2025-11-20
- Results first posted
- 2025-11-20
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Urine Albumin-creatinine Ratio (UA/C) at Week 24 | Week 24 | The change from baseline in UA/C at Week 24 based on first morning void (FMV) samples |
| Secondary | UA/C <0.2 g/g at Week 24 | Week 24 | Achievement of UA/C of \<0.2 g/g at Week 24 based on FMV samples |
| Secondary | 30% Reduction From Baseline in UA/C at Week 24 | Week 24 | Achievement of 30% reduction from baseline in UA/C at Week 24 based on FMV samples |
| Secondary | 50% Reduction From Baseline in UA/C at Week 24 | Week 24 | Achievement of 50% reduction from baseline in UA/C at Week 24 based on FMV samples |
| Secondary | Change in Urine Protein-to-creatinine Ratio (UP/C) at Week 24 | Week 24 | The change from baseline in UP/C at Week 24 based on FMV samples |
| Secondary | Estimated Glomerular Filtration Rate (eGFR) | Week 24 | Change from baseline estimated glomerular filtration rate at 24 weeks |
| Secondary | Systolic Blood Pressure (BP) at Week 24 | Week 24 | The change from baseline in systolic BP at Week 24 |
| Secondary | Change in Diastolic Blood Pressure (BP) | Week 24 | The change from baseline in diastolic BP at Week 24 |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Urine Albumin-creatinine Ratio (UA/C) at Week 24 | Week 24 | Full Analysis Set | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | UA/C <0.2 g/g at Week 24 | Week 24 | Full Analysis Set | percentage of participants | NUMBER |
| SECONDARY | 30% Reduction From Baseline in UA/C at Week 24 | Week 24 | UA/C Responder Endpoints While on Treatment | percentage of participants | NUMBER |
| SECONDARY | 50% Reduction From Baseline in UA/C at Week 24 | Week 24 | Full Analysis Set | percentage of participants | NUMBER |
| SECONDARY | Change in Urine Protein-to-creatinine Ratio (UP/C) at Week 24 | Week 24 | Full Analysis Set | percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Estimated Glomerular Filtration Rate (eGFR) | Week 24 | Full Analysis Set | mL/min/1.73 square meter | GEOMETRIC_MEAN |
| SECONDARY | Systolic Blood Pressure (BP) at Week 24 | Week 24 | Full Analysis Set | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Diastolic Blood Pressure (BP) | Week 24 | Full Analysis Set | mmHg | 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 |
|---|---|---|---|---|---|
| Change in Urine Albumin-creatinine Ratio (UA/C) at Week 24 | Sparsentan | -55.78 | 95% Confidence Interval -65.8 to -42.8 | percent change | |
| UA/C <0.2 g/g at Week 24 | Sparsentan | 31 | 95% Confidence Interval 17.0 to 47.6 | percentage of participants | |
| 30% Reduction From Baseline in UA/C at Week 24 | Sparsentan | 77 | 95% Confidence Interval 60.7 to 88.9 | percentage of participants | |
| 50% Reduction From Baseline in UA/C at Week 24 | Sparsentan | 51 | 95% Confidence Interval 34.8 to 67.6 | percentage of participants | |
| Change in Urine Protein-to-creatinine Ratio (UP/C) at Week 24 | Sparsentan | -45.20 | 95% Confidence Interval -54.6 to -33.9 | percentage change | |
| Estimated Glomerular Filtration Rate (eGFR) | Sparsentan | -2.0 | 95% Confidence Interval -3.9 to -0.1 | mL/min/1.73 square meter | |
| Systolic Blood Pressure (BP) at Week 24 | Sparsentan | -3.4 | 95% Confidence Interval -6.8 to 0.0 | mmHg | |
| Change in Diastolic Blood Pressure (BP) | Sparsentan | -4.6 | 95% Confidence Interval -6.7 to -2.4 | mmHg |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sparsentan | 48 | |
| Overall Study | Discontinued | Sparsentan | 7 | |
| Overall Study | COMPLETED | Sparsentan | 41 | |
| Overall Study | NOT COMPLETED | Sparsentan | 7 |
Source ClinicalTrials.gov
Adverse events11
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 | Hypotension | Vascular disorders | Sparsentan | 7 | 48 | |
| other | Headache | Nervous system disorders | Sparsentan | 4 | 48 | |
| other | Oedema | General disorders | Sparsentan | 4 | 48 | |
| other | Oedema peripheral | General disorders | Sparsentan | 4 | 48 | |
| other | Upper respiratory tract infection | Infections and infestations | Sparsentan | 4 | 48 | |
| other | Dizziness | Nervous system disorders | Sparsentan | 3 | 48 | |
| serious | Osteoarthritis | Musculoskeletal and connective tissue disorders | Sparsentan | 1 | 48 | 1 |
| serious | Cerebrovascular event | Nervous system disorders | Sparsentan | 1 | 48 | 1 |
| serious | Acute kidney injury | Renal and urinary disorders | Sparsentan | 1 | 48 | 1 |
| serious | Deep vein thrombosis | Vascular disorders | Sparsentan | 1 | 48 | 1 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sparsentan | 0 | 48 |
| Total, other adverse events | Sparsentan | 26 | 48 |
| Total, serious adverse events | Sparsentan | 4 | 48 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT05856760
GET https://conductscience.org/api/trials/v1/NCT05856760/registered