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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryChange in Urine Albumin-creatinine Ratio (UA/C) at Week 24Week 24The change from baseline in UA/C at Week 24 based on first morning void (FMV) samples
SecondaryUA/C <0.2 g/g at Week 24Week 24Achievement of UA/C of \<0.2 g/g at Week 24 based on FMV samples
Secondary30% Reduction From Baseline in UA/C at Week 24Week 24Achievement of 30% reduction from baseline in UA/C at Week 24 based on FMV samples
Secondary50% Reduction From Baseline in UA/C at Week 24Week 24Achievement of 50% reduction from baseline in UA/C at Week 24 based on FMV samples
SecondaryChange in Urine Protein-to-creatinine Ratio (UP/C) at Week 24Week 24The change from baseline in UP/C at Week 24 based on FMV samples
SecondaryEstimated Glomerular Filtration Rate (eGFR)Week 24Change from baseline estimated glomerular filtration rate at 24 weeks
SecondarySystolic Blood Pressure (BP) at Week 24Week 24The change from baseline in systolic BP at Week 24
SecondaryChange in Diastolic Blood Pressure (BP)Week 24The change from baseline in diastolic BP at Week 24

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange in Urine Albumin-creatinine Ratio (UA/C) at Week 24Week 24Full Analysis Setpercent changeLEAST_SQUARES_MEAN
SECONDARYUA/C <0.2 g/g at Week 24Week 24Full Analysis Setpercentage of participantsNUMBER
SECONDARY30% Reduction From Baseline in UA/C at Week 24Week 24UA/C Responder Endpoints While on Treatmentpercentage of participantsNUMBER
SECONDARY50% Reduction From Baseline in UA/C at Week 24Week 24Full Analysis Setpercentage of participantsNUMBER
SECONDARYChange in Urine Protein-to-creatinine Ratio (UP/C) at Week 24Week 24Full Analysis Setpercentage changeLEAST_SQUARES_MEAN
SECONDARYEstimated Glomerular Filtration Rate (eGFR)Week 24Full Analysis SetmL/min/1.73 square meterGEOMETRIC_MEAN
SECONDARYSystolic Blood Pressure (BP) at Week 24Week 24Full Analysis SetmmHgLEAST_SQUARES_MEAN
SECONDARYChange in Diastolic Blood Pressure (BP)Week 24Full Analysis SetmmHgLEAST_SQUARES_MEAN

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Change in Urine Albumin-creatinine Ratio (UA/C) at Week 24Sparsentan-55.7895% Confidence Interval -65.8 to -42.8percent change
UA/C <0.2 g/g at Week 24Sparsentan3195% Confidence Interval 17.0 to 47.6percentage of participants
30% Reduction From Baseline in UA/C at Week 24Sparsentan7795% Confidence Interval 60.7 to 88.9percentage of participants
50% Reduction From Baseline in UA/C at Week 24Sparsentan5195% Confidence Interval 34.8 to 67.6percentage of participants
Change in Urine Protein-to-creatinine Ratio (UP/C) at Week 24Sparsentan-45.2095% Confidence Interval -54.6 to -33.9percentage change
Estimated Glomerular Filtration Rate (eGFR)Sparsentan-2.095% Confidence Interval -3.9 to -0.1mL/min/1.73 square meter
Systolic Blood Pressure (BP) at Week 24Sparsentan-3.495% Confidence Interval -6.8 to 0.0mmHg
Change in Diastolic Blood Pressure (BP)Sparsentan-4.695% Confidence Interval -6.7 to -2.4mmHg

Participant flow4

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDSparsentan48
Overall StudyDiscontinuedSparsentan7
Overall StudyCOMPLETEDSparsentan41
Overall StudyNOT COMPLETEDSparsentan7

Adverse events11

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherHypotensionVascular disordersSparsentan748
otherHeadacheNervous system disordersSparsentan448
otherOedemaGeneral disordersSparsentan448
otherOedema peripheralGeneral disordersSparsentan448
otherUpper respiratory tract infectionInfections and infestationsSparsentan448
otherDizzinessNervous system disordersSparsentan348
seriousOsteoarthritisMusculoskeletal and connective tissue disordersSparsentan1481
seriousCerebrovascular eventNervous system disordersSparsentan1481
seriousAcute kidney injuryRenal and urinary disordersSparsentan1481
seriousDeep vein thrombosisVascular disordersSparsentan1481

Adverse event totals3

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalitySparsentan048
Total, other adverse eventsSparsentan2648
Total, serious adverse eventsSparsentan448

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