A Phase 3 interventional study of sparsentan and Irbesartan in Focal Segmental Glomerulosclerosis, sponsored by Travere Therapeutics, Inc.. Completed at 226 sites in 22 countries. Open to participants aged 8 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by Travere Therapeutics, Inc. · Phase 3, Interventional, and Treatment
Among 68 studies in Glomerulosclerosis, Focal Segmental with a site in United States — 17 open to participants now, 20 under way, 2 of them phase 3. Glomerulosclerosis, Focal Segmental · United States.
Among the 68 studies in Glomerulosclerosis, Focal Segmental with a site in United States, this one is the 2nd largest by enrollment of the 56 interventional ones that give a count, is one of 5 that started in 2018, is one of 5 in phase 3, and was the 35th registered.
105 studies on the registry are indexed under Glomerulosclerosis, Focal Segmental; 33 are open to participants now.
Browse Glomerulosclerosis, Focal Segmental studies →17 of the 68 studies in Glomerulosclerosis, Focal Segmental with a site in United States are open now. Recruiting first, the newest first:
National Human Genome Research Institute (NHGRI) · Sites in United States
Boehringer Ingelheim · Sites in United States, Argentina, Australia and 37 more countries
Akebia Therapeutics · Sites in United States
Meyer Children's Hospital IRCCS · Sites in United States, Germany, Italy and 2 more countries
Sanofi · Sites in United States, Argentina, Australia and 19 more countries
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 30 Glomerulosclerosis, Focal Segmental studies recruiting now, 11 (37%) set no upper age limit and 12 (40%) stop at 75 or younger; 22 take children under 18; 2 take healthy volunteers.
This study: 8 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
68 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 31 · Phase 3 5 · Phase 4 4
First in 1996; this study’s year is marked. 5 started in 2018.
This study's enrollment of 371 is above the median of 30 across 73 interventional studies indexed under Glomerulosclerosis, Focal Segmental.
Median enrollment 30 across the 56 interventional studies, 201 across the 12 observational. Of the 45 that completed or were terminated, 23 (51%) have results posted.
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33 of 68 have an industry lead sponsor. The 10 most frequent:
Travere Therapeutics, Inc. is the lead sponsor of 14 studies on the registry; 4 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Travere Therapeutics, Inc. has 6 studies filed under Glomerulosclerosis, Focal Segmental — fewer than ten, so there is no comparison to draw.
10 of the studies in Glomerulosclerosis, Focal Segmental with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01094327University of MiamiProteinuria in Pre and Post Transplant | 2026-11-30 |
| NCT06500702SanofiA Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease | 2026-12-23 |
| NCT07219121Travere Therapeutics, Inc.Sparsentan in Posttransplant Immunoglobulin A Nephropathy or Focal Segmental Glomerulosclerosis | 2027-03 |
| NCT05583942Northwell HealthA Pilot Trial of taVNS for SRNS in Children (kidNEY-VNS) | 2027-03-01 |
| NCT05588063Northwell HealthtaVNS for FRNS in Children | 2027-03-01 |
Among the 68 studies in Glomerulosclerosis, Focal Segmental with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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To determine the long-term nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with primary and genetic focal segmental glomerulosclerosis (FSGS).
This is a randomized, multicenter, double-blind, parallel, active-control study. Approximately 300 patients aged 8 to 75 years (inclusive) will be enrolled in the study. The study will be conducted in approximately 300 study centers, globally. The investigational drug (sparsentan) is a dual-acting angiotensin receptor blocker and endothelin receptor antagonist. The active control is irbesartan. Patients who meet eligibility criteria will require washout from renin-angiotensin-aldosterone system (RAAS) blockers, if applicable prior to their first dose of study drug.
Patients will be randomly assigned in a 1:1 ratio to receive either sparsentan or active control (irbesartan).
After completing the double-blind portion of the study, patients may participate in the open-label extension for treatment with sparsentan if they meet eligibility criteria.
Primary completion date represents the anticipated completion date of the double-blind portion of the study. Study completion date represents the anticipated completion date of the open-label extension portion of the study.
Key Inclusion Criteria for the Double-blind Period:
Key Exclusion Criteria for the Double-blind Period:
Key Inclusion Criteria for the Open-label Extension Based on assessments at the Week 108 visit:
Key Exclusion Criteria for the Open-label Extension Based on Assessments at Week 108 and 112 visits:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sparsentan will be administered as a single oral dose; an initial dose of 400 mg daily titrating up to a target dose of 800 mg, daily
Drug: sparsentan
Irbesartan will be administered as a single oral dose; an initial dose of 150 mg daily titrating up to a target dose of 300 mg, daily
Drug: Irbesartan
Double-blind period: target dose of 800 mg daily; Open-label extension: target dose based on dosage from week 114 daily
Also known as: RE-021
target dose of 300 mg daily
Also known as: Irbesartan Tablets USP
Slope of Estimated Glomerular Filtration Rate (eGFR)
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.
Time frame: From Day 1 to Week 108
Percentage of Participants Achieving FSGS Partial Remission Endpoint (FPRE)
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.
Time frame: Week 36
Slope of eGFR Following the Initial Acute Effect of Randomized Treatment
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.
Time frame: From Week 6 to Week 108
Change From Baseline in eGFR to 4 Weeks Post-cessation of Randomized Treatment
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.
Time frame: Baseline (Day 1) to Week 112
The DUPLEX study is a 112-week, Phase 3, randomized, multicenter, double-blind (DB), parallel, active-control study that evaluated the safety, tolerability, and long-term nephroprotective potential of treatment with sparsentan as compared to irbesartan in participants with focal segmental glomerulosclerosis (FSGS).
| Milestone | Sparsentan | Irbesartan |
|---|---|---|
| Started | 184 | 187 |
| Completed | 168 | 171 |
| Not completed | 16 | 16 |
| Withdrew: Death | 4 | 3 |
| Withdrew: Lost to follow-up | 3 | 2 |
| Withdrew: Physician decision | 2 | 0 |
| Withdrew: Withdrawal by subject | 7 | 11 |
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.
| milliliters/minute/1.73square meter/year | Sparsentan | Irbesartan |
|---|---|---|
| Slope of Estimated Glomerular Filtration Rate (eGFR) | -5.4 (-6.89 to -3.93) | -5.7 (-7.20 to -4.29) |
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.
| Percentage of participants | Sparsentan | Irbesartan |
|---|---|---|
| Percentage of Participants Achieving FSGS Partial Remission Endpoint (FPRE) | 42.0 | 26.0 |
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.
| milliliters/minute/1.73square meter/year | Sparsentan | Irbesartan |
|---|---|---|
| Slope of eGFR Following the Initial Acute Effect of Randomized Treatment | -4.8 (-6.34 to -3.27) | -5.7 (-7.20 to -4.18) |
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.
| milliliters/minute/1.73square meter | Sparsentan | Irbesartan |
|---|---|---|
| Change From Baseline in eGFR to 4 Weeks Post-cessation of Randomized Treatment | -10.4 (-12.60 to -8.13) | -12.1 (-14.36 to -9.91) |
Collected over Up to Week 112. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sparsentan | 4/184 (2.2%) | 68/184 (37%) | 172/184 (93.5%) |
| Irbesartan | 3/187 (1.6%) | 82/187 (43.9%) | 174/187 (93%) |
| Event | Sparsentan | Irbesartan |
|---|---|---|
| COVID-19Infections and infestations | 22/184 | 39/187 |
| Chronic kidney diseaseRenal and urinary disorders | 11/184 | 13/187 |
| Acute kidney injuryRenal and urinary disorders | 3/184 | 8/187 |
| Nephrotic syndromeRenal and urinary disorders | 5/184 | 3/187 |
| Oedema peripheralGeneral disorders | 0/184 | 5/187 |
| PneumoniaInfections and infestations | 3/184 | 2/187 |
| Renal impairmentRenal and urinary disorders | 3/184 | 1/187 |
| Fluid overloadMetabolism and nutrition disorders | 3/184 | 0/187 |
| Urinary tract infectionInfections and infestations | 1/184 | 3/187 |
| COVID-19 pneumoniaInfections and infestations | 2/184 | 2/187 |
| Event | Sparsentan | Irbesartan |
|---|---|---|
| COVID-19Infections and infestations | 41/184 | 50/187 |
| Oedema peripheralGeneral disorders | 36/184 | 41/187 |
| HypotensionVascular disorders | 33/184 | 21/187 |
| HyperkalaemiaMetabolism and nutrition disorders | 31/184 | 20/187 |
| DiarrhoeaGastrointestinal disorders | 25/184 | 27/187 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 25/184 | 15/187 |
| AnaemiaBlood and lymphatic system disorders | 24/184 | 10/187 |
| HypertensionVascular disorders | 20/184 | 24/187 |
| DizzinessNervous system disorders | 23/184 | 21/187 |
| HeadacheNervous system disorders | 20/184 | 23/187 |
Full Analysis Set comprised of all participants who were randomized and received at least one dose of double-blind study medication.
| Age, Continuous(Years) | Sparsentan | Irbesartan | Total |
|---|---|---|---|
| Mean | 41.7 ± 16.53 | 41.5 ± 17.25 | 41.6 ± 16.87 |
| Sex: Female, Male(Participants) | Sparsentan | Irbesartan | Total |
|---|---|---|---|
| Female | 83 | 88 | 171 |
| Male | 101 | 99 | 200 |
| Ethnicity (NIH/OMB)(Participants) | Sparsentan | Irbesartan | Total |
|---|---|---|---|
| Hispanic or Latino | 34 | 44 | 78 |
| Not Hispanic or Latino | 147 | 135 | 282 |
| Unknown or Not Reported | 3 | 8 | 11 |
| Race/Ethnicity, Customized(Participants) | Sparsentan | Irbesartan | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 23 | 27 | 50 |
| Black or African American | 16 | 9 | 25 |
| Native Hawaiian or Other Pacific Islander | 2 | 0 | 2 |
| White | 134 | 135 | 269 |
| Other | 5 | 12 | 17 |
| Multiple | 3 | 4 | 7 |
Showing the first 100 of 226 sites across 22 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Requests for clinical trial data, including language stating its intended use, should be directed to datarequest@travere.com. If approved, the requested information will be provided to the requestor after signing a data access agreement. Requests can be made following completion of the study and full publication of the study data in a peer reviewed journal for up to 36 months following its publication. Travere reserves the right to decline or recommend modifications to a request if it does not comply with the data sharing policy or if it is determined that the request is made by a biased source.
Time frame: Requests can be made following completion of the study and full publication of the study data in a peer reviewed journal for up to 36 months following its publication.
Access criteria: Requires submission and approval of intended use and a data sharing agreement.
Ran from Apr 2018 to primary completion in Mar 2023, 59 months.
Results were first posted in Apr 2024, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sparsentan
Glomerulosclerosis, Focal Segmental →
Travere Therapeutics, Inc.