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Angiotensin Receptor Blocker and Endothelin Receptor Antagonist

Sparsentan for Proteinuric Kidney Disease (EPPIK Trial)

Phase 2
Recruiting
Research Sponsored by Travere Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For Population 1: The subject is male or female ≥1 year at screening and <18 years of age at Day 1 (Baseline)
For Population 1: The subject has a documented kidney biopsy-proven FSGS histological pattern with specific clinical presentation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at scheduled day 1, day 2 and week 12 visits for population 1 and 2. at scheduled day 1 and week 4, 8, 12, 24, 36, 48, 60, 72, 84, and 96 visits for population 3.
Awards & highlights

EPPIK Trial Summary

This trial is testing a drug to see if it is safe, works well, and is tolerated by patients. It will also assess how much protein is in urine after taking the drug.

Who is the study for?
This trial is for kids and teens with certain kidney diseases like FSGS or MCD, who have high levels of protein in their urine. They must be healthy enough in other ways (like liver function and blood pressure) to take part. Kids under a specific weight or those with certain medical conditions can't join.Check my eligibility
What is being tested?
The trial tests Sparsentan, an oral medication given once daily to see if it's safe, works well, and is tolerable over a period of 108 weeks. It specifically looks at how the drug affects the amount of protein in the urine among young patients.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include issues related to blood pressure changes due to Sparsentan's action on blood vessels and any common reactions from taking new medications orally.

EPPIK Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am under 18 years old and older than 1 year.
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I have FSGS confirmed by a kidney biopsy.
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My kidney biopsy shows I have FSGS or MCD.
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I have a genetic mutation linked to my kidney condition.
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My kidney function test shows a filtration rate of at least 30 mL/min.
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I am between 2 and 17 years old.

EPPIK Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at scheduled day 1, day 2 and week 12 visits for population 1 and 2. at scheduled day 1 and week 4, 8, 12, 24, 36, 48, 60, 72, 84, and 96 visits for population 3.
This trial's timeline: 3 weeks for screening, Varies for treatment, and at scheduled day 1, day 2 and week 12 visits for population 1 and 2. at scheduled day 1 and week 4, 8, 12, 24, 36, 48, 60, 72, 84, and 96 visits for population 3. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), AEs leading to treatment discontinuation, and adverse events of interest (AEOIs)
Urine protein/creatinine ratio (UP/C) at week 108
Secondary outcome measures
Estimated glomerular filtration rate (eGFR) over 108 weeks
Observed plasma Pharmacokinetic (PK) concentrations
Proportion of subjects achieving complete remission of proteinuria
+6 more

EPPIK Trial Design

3Treatment groups
Experimental Treatment
Group I: Population 3: IgANExperimental Treatment1 Intervention
Subjects with kidney biopsy-confirmed IgAN
Group II: Population 2: IgAN, IgAV, or ASExperimental Treatment1 Intervention
Subjects with kidney biopsy-confirmed immunoglobulin A nephropathy (IgAN), immunoglobulin A vasculitis (IgAV), or Alport syndrome (AS)
Group III: Population 1: FSGS and/or MCDExperimental Treatment1 Intervention
Subjects with selected proteinuric glomerular diseases associated with FSGS and MCD histological patterns

Find a Location

Who is running the clinical trial?

Travere Therapeutics, Inc.Lead Sponsor
20 Previous Clinical Trials
177,569 Total Patients Enrolled
Radko Komers, MD, PhDStudy DirectorTravere Therapeutics, Inc.

Media Library

Sparsentan (Angiotensin Receptor Blocker and Endothelin Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05003986 — Phase 2
Alport Syndrome Research Study Groups: Population 3: IgAN, Population 1: FSGS and/or MCD, Population 2: IgAN, IgAV, or AS
Alport Syndrome Clinical Trial 2023: Sparsentan Highlights & Side Effects. Trial Name: NCT05003986 — Phase 2
Sparsentan (Angiotensin Receptor Blocker and Endothelin Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05003986 — Phase 2
Alport Syndrome Patient Testimony for trial: Trial Name: NCT05003986 — Phase 2

Frequently Asked Questions

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

What are the requirements for participating in this clinical trial?

"The age requirement for this study is between 1 year old to 17 years old. 57 participants are needed for the trial, which specifically focuses on iga vasculitis."

Answered by AI

Can someone who meets the qualifications join this trial right now?

"The latest information available on clinicaltrials.gov shows that this trial is still open and recruiting patients. The listing was first posted on August 12th, 2021 and was updated September 22nd, 2022."

Answered by AI

Does this research project include young people in its target demographic?

"The age range for participants in this study is one to seventeen years old."

Answered by AI

What are the benefits that this clinical trial could bring about?

"The purpose of this study, which will be ongoing for 108 weeks, is to observe the levels of urine protein/creatinine ratio (UP/C) in patients. Other things that will be monitored include observed plasma pharmacokinetic concentrations at different time points and visits, as well as the change in urine albumin/creatinine ratio (UA/C) over the 112 weeks. Lastly, steady-state PK parameters area under the plasma concentration-time curve during a dosing interval ([AUCτ]) will also be noted."

Answered by AI

How many individuals are being observed in this test?"

"That is correct, the online information does show that this clinical trial is looking for new participants. The 8/12/2021 date refers to when the study was originally posted and 9/22/2022 indicates the most recent update. There are 57 total spots available at 19 different hospitals or research facilities."

Answered by AI

Are there any other ongoing or previous research studies that have used Sparsentan?

"Sparsentan was first researched in 2014 at General Teaching Hospital Prague. So far, there have been 2 completed studies with 5 more active trials underway; a few of these are based in New Hyde Park, New york."

Answered by AI

When can we expect Sparsentan to be cleared for public use?

"Sparsentan's safety is based on Phase 2 clinical trial data, which means that while there is evidence that it does not cause severe harm, there is no indication yet of whether or not the drug is effective."

Answered by AI

How many different sites are coordinating this trial?

"You can participate in this trial at any of the 19 total sites, which include locations like New Hyde Park, Wilmington and Iowa City. To limit travel, try to pick a medical centre near your home."

Answered by AI

Have other research teams looked into this topic before?

"At the moment, there are 5 ongoing studies for Sparsentan in 166 towns and 24 countries. The very first clinical trial took place back in 2014. That particular study, which was funded by Travere Therapeutics, Inc., had 109 patients and completed Phase 2 of drug approval. In the years since 2014, 2 more trials have been successfully completed."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What site did they apply to?
Travere Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I want to help with discovering a drug that could help people with CKD, such as me. Dr. Charles Patton, D. Min.
PatientReceived 1 prior treatment
~20 spots leftby May 2025