67 Participants Needed

Sparsentan for Proteinuric Kidney Disease

(EPPIK Trial)

Recruiting at 38 trial locations
TC
Overseen ByTravere Call Center
Age: < 18
Sex: Any
Trial Phase: Phase 2
Sponsor: Travere Therapeutics, Inc.
Must be taking: ACEI, ARB
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing sparsentan, a daily oral medication, in children with specific kidney diseases that cause high protein levels in urine. The goal is to see if it is safe and effective. Sparsentan helps by reducing protein leakage into the urine, which can protect the kidneys.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot participate if you need any prohibited medications or if you are on chronic immunosuppressive medications that haven't been stable for at least a month before screening.

Is Sparsentan safe for humans?

Sparsentan has been studied for safety in clinical trials for kidney diseases like IgA nephropathy and focal segmental glomerulosclerosis (FSGS). These studies suggest it has a favorable safety profile, meaning it is generally safe for humans.12345

How is the drug Sparsentan different from other treatments for proteinuric kidney disease?

Sparsentan is unique because it is a dual endothelin angiotensin receptor antagonist, meaning it blocks two pathways that contribute to kidney damage, unlike other treatments that typically target only one. It is also non-immunosuppressive, which means it doesn't weaken the immune system, and is taken orally.12456

What data supports the effectiveness of the drug Sparsentan for proteinuric kidney disease?

Sparsentan has been shown to reduce proteinuria (excess protein in urine) in patients with IgA nephropathy and focal segmental glomerulosclerosis (FSGS), which are types of kidney diseases. It was approved in the USA for reducing proteinuria in adults with IgA nephropathy, and studies have shown it to be more effective than irbesartan, another drug used for similar conditions.12457

Who Is on the Research Team?

RK

Radko Komers, MD, PhD

Principal Investigator

Travere Therapeutics, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

For Population 2: You have a certain level of protein in your urine and meet specific diagnosis criteria.
Your urine protein levels are too high and meet specific diagnostic criteria.
I have FSGS confirmed by a kidney biopsy.
See 6 more

Exclusion Criteria

My kidney disease is due to FSGS or MCD.
I weigh less than 7.3 kg.
The subject has a history of allergic response to specific medications
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sparsentan treatment to evaluate safety, efficacy, and pharmacokinetics over 108 weeks

108 weeks
Multiple visits including Day 1, Day 2, Week 12, and every 12 weeks thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Sparsentan
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Population 3: IgANExperimental Treatment1 Intervention
Group II: Population 2: IgAN, IgAV, or ASExperimental Treatment1 Intervention
Group III: Population 1: FSGS and/or MCDExperimental Treatment1 Intervention

Sparsentan is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Filspari for:
🇪🇺
Approved in European Union as Filspari for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Travere Therapeutics, Inc.

Lead Sponsor

Trials
23
Recruited
103,000+

Published Research Related to This Trial

Sparsentan (FILSPARI™) is an oral medication that acts as a dual endothelin and angiotensin receptor antagonist, specifically developed for treating IgA nephropathy and FSGS.
In February 2023, sparsentan received accelerated approval in the USA for its effectiveness in reducing proteinuria in adults with primary IgA nephropathy, particularly those at risk of rapid disease progression.
Sparsentan: First Approval.Syed, YY.[2023]
In a phase 3 trial involving 406 patients with IgA nephropathy, sparsentan significantly reduced proteinuria by 40% compared to irbesartan over 110 weeks, indicating its efficacy in managing kidney disease.
Sparsentan also demonstrated a slower decline in kidney function (eGFR) compared to irbesartan, suggesting it may help preserve kidney health without introducing new safety concerns.
Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a randomised, active-controlled, phase 3 trial.Rovin, BH., Barratt, J., Heerspink, HJL., et al.[2023]
In a phase 3 trial involving 404 adults with IgA nephropathy, sparsentan significantly reduced proteinuria by 49.8% compared to a 15.1% reduction with irbesartan, indicating its superior efficacy in managing this condition.
The safety profile of sparsentan was comparable to irbesartan, with no severe adverse events reported, suggesting it is a safe treatment option for patients.
Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial.Heerspink, HJL., Radhakrishnan, J., Alpers, CE., et al.[2023]

Citations

Sparsentan: First Approval. [2023]
Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a randomised, active-controlled, phase 3 trial. [2023]
Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial. [2023]
Sparsentan versus Irbesartan in Focal Segmental Glomerulosclerosis. [2023]
Efficacy and Safety of Sparsentan Compared With Irbesartan in Patients With Primary Focal Segmental Glomerulosclerosis: Randomized, Controlled Trial Design (DUET). [2022]
Study Design of the Phase 3 Sparsentan Versus Irbesartan (DUPLEX) Study in Patients With Focal Segmental Glomerulosclerosis. [2022]
IgA Nephropathy Patient Baseline Characteristics in the Sparsentan PROTECT Study. [2023]
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