Your session is about to expire
← Back to Search
Sparsentan for Proteinuric Kidney Disease (EPPIK Trial)
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.
EPPIK Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowEPPIK Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.EPPIK Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- My kidney disease is due to FSGS or MCD.I weigh less than 7.3 kg.I have had cancer in the last 2 years.You have certain blood or mineral level problems when screened.For Population 2: You have a certain level of protein in your urine and meet specific diagnosis criteria.I have been on a stable dose of my immunosuppressive medication for at least 1 month.I needed a new type of immune system treatment for my kidney condition in the last 6 months.Your urine protein levels are too high and meet specific diagnostic criteria.I am under 18 years old and older than 1 year.I have FSGS confirmed by a kidney biopsy.I am pregnant, planning to become pregnant, or am breastfeeding.I have had an organ transplant, but not of the cornea.Your blood pressure is not within the normal range for your sex and height.I have a documented history of heart conditions.I agree to use effective birth control methods if I can have children.I have liver conditions or abnormal liver tests.I do not need any medication that the study does not allow.I have previously taken sparsentan.I have IgA deposits in my kidneys not due to primary IgAN or IgAV.My kidney biopsy shows I have FSGS or MCD.I have a genetic mutation linked to my kidney condition.I or my guardian might not follow the study's requirements.My kidney function test shows a filtration rate of at least 30 mL/min.I am between 2 and 17 years old.
- Group 1: Population 3: IgAN
- Group 2: Population 1: FSGS and/or MCD
- Group 3: Population 2: IgAN, IgAV, or AS
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
Share this study with friends
Copy Link
Messenger