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Dual-acting Receptor Antagonist

Sparsentan for Focal Segmental Glomerulosclerosis (DUET Trial)

Phase 2
Waitlist Available
Led By Howard Trachtman, M.D.
Research Sponsored by Travere Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Mean seated blood pressure (BP) >100/60 mmHg and <145/95 in patients >/= 18 years of age. Mean seated BP for patients <18 years of age should be >90/60 mmHg and <95th percentile for age, gender, and height
Biopsy-proven primary FSGS (Primary FSGS confirmed by renal biopsy report) OR documentation of a genetic mutation in a podocyte protein associated with the disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

DUET Trial Summary

This trial will study whether the drug RE-021 is safe and effective in treating patients with focal segmental glomerulosclerosis, a kidney disease.

Who is the study for?
This trial is for people with a kidney condition called FSGS. They must have protein in their urine and either a biopsy-proven diagnosis or certain genetic mutations. Ages range from 8 to 75, depending on the region, and they need stable blood pressure and kidney function. Those on some immunosuppressants can join if doses are steady.Check my eligibility
What is being tested?
The study tests RE-021 (Sparsentan), which targets two receptors that may affect FSGS, against Irbesartan, an existing medication. It's randomized and double-blind, meaning neither participants nor researchers know who gets which treatment until after the results are analyzed.See study design
What are the potential side effects?
Possible side effects of Sparsentan could include dizziness due to low blood pressure, swelling caused by fluid retention, elevated potassium levels which can affect heart rhythm, liver enzyme changes indicating potential liver issues, and allergic reactions.

DUET Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood pressure is within the required range for my age.
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My kidney disease (FSGS) is confirmed by a biopsy or a genetic test.

DUET Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Change in Urine Protein/Creatinine (Up/C)

DUET Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: RE-021 (Sparsentan) 800 mgExperimental Treatment1 Intervention
RE-021 (Sparsentan) will be administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose will be 800mg. Patients at </= 50kg will receive half of the RE-021 (Sparsentan) dose for the 8 week duration.
Group II: RE-021 (Sparsentan) 400 mgExperimental Treatment1 Intervention
RE-021 (Sparsentan) will be administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose will be 400mg. Patients at </= 50kg will receive half of the RE-021 (Sparsentan) dose for the 8 week duration.
Group III: RE-021 (Sparsentan) 200 mgExperimental Treatment1 Intervention
RE-021 (Sparsentan) will be administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose will be 200mg. Patients at </= 50kg will receive half of the RE-021 (Sparsentan) dose for the 8 week duration.
Group IV: Irbesartan 300 mgActive Control1 Intervention
The control will be administered irbesartan as a single oral dose of 150mg for the first week before escalating to 300mg for the remaining 7 weeks. Patients at </= 50kg will receive 150mg irbesartan for the 8 week duration.

Find a Location

Who is running the clinical trial?

Travere Therapeutics, Inc.Lead Sponsor
20 Previous Clinical Trials
177,527 Total Patients Enrolled
Howard Trachtman, M.D.Principal InvestigatorNYU School of Medicine

Media Library

RE-021 (Sparsentan) (Dual-acting Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01613118 — Phase 2
Focal Segmental Glomerulosclerosis Research Study Groups: RE-021 (Sparsentan) 400 mg, RE-021 (Sparsentan) 200 mg, RE-021 (Sparsentan) 800 mg, Irbesartan 300 mg
Focal Segmental Glomerulosclerosis Clinical Trial 2023: RE-021 (Sparsentan) Highlights & Side Effects. Trial Name: NCT01613118 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What primary ailment is RE-021 (Sparsentan) employed in the treatment of?

"The most common way to address conditions that are not effectively managed by monotherapy is to prescribe RE-021 (Sparsentan). This medication may also help individuals with a first untreated hypertension diagnosis and those who need multiple anti-hypertensive medications."

Answered by AI

What is the participant capacity of this clinical trial?

"Unfortunately this research is no longer accepting applicants. The trial was first announced on March 1st 2014 and last updated November 28th 2022. If you wish to find other studies, there are currently 15 trials focused on hyalinosis segmental glomerular recruiting patients as well as 9 involving RE-021 (Sparsentan)."

Answered by AI

Does this clinical investigation accept participants aged 25 or older?

"This clinical trial requires applicants to be aged between 8 and 75. For those who are younger or older, 13 trials for the former age group and 18 studies exist respectively."

Answered by AI

What are the associated risks of taking RE-021 (Sparsentan)?

"The safety of RE-021 has been assessed at a rating of 2, as the drug is in its second phase with evidence for safety but no confirmation yet on efficacy."

Answered by AI

May I be admitted to participate in this experiment?

"This medical trial is seeking 109 participants, aged between 8 and 75 years-old that have been diagnosed with hyalinosis, segmental glomerular. Furthermore, it is imperative for potential patients to meet the following conditions: Biopsy results confirming primary FSGS; eGFR of more than 30; mean seated blood pressure (for those 18 or older) should be in range 100/60 mmHg - 145/95mmHg and 90/60 mmHg - 95th percentile for age, gender & height (for younger applicants); immunosuppressive medication dosages must remain stable over a month prior to randomization"

Answered by AI

In what locations is this investigation accessible?

"Currently, 31 medical facilities are entailing this experiment. These locations stretch from Denver to Cleveland and New york with many other sites in between. To reduce travelling difficulties, it is advisable for participants to pick the closest centre possible when enrolling."

Answered by AI

Are there any additional case studies involving RE-021 (Sparsentan)?

"Currently, 9 studies are being conducted on RE-021 (Sparsentan), 4 of which have progressed to the third phase. These trials are primarily taking place in Pavia, Texas; however this treatment is also being trialled at 1,026 other sites worldwide."

Answered by AI

Is this research venture currently recruiting participants?

"Unfortunately, this particular trial is no longer accepting applications. It was initially posted on March 1st 2014 and the latest update came in November 28th 2022. However, if you are still hoping to participate in a study related to hyalinosis or segmental glomerulars there are 15 trials open at the time of writing; 9 of which involve RE-021 (Sparsentan)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis
2014. "Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01613118.
~10 spots leftby Apr 2025
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