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Angiotensin Receptor Blocker
Sparsentan for IgA Nephropathy (PROTECT Trial)
Phase 3
Waitlist Available
Research Sponsored by Travere Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years or older at screening
eGFR ≥30 mL/min/1.73 m2 at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 110 postrandomization
Awards & highlights
PROTECT Trial Summary
This trial is comparing the long-term effects of two different medications on kidney function in people with IgA nephropathy.
Who is the study for?
Adults with IgA Nephropathy (kidney disease) who've completed a previous study phase, have stable blood pressure and kidney function, are on certain blood pressure meds, and agree to contraception can join. Excluded if they're pregnant/breastfeeding, drug/alcohol disorder, severe liver issues, high potassium levels or taking disallowed medications.Check my eligibility
What is being tested?
The trial is testing the long-term kidney protection of Sparsentan compared to an angiotensin receptor blocker in patients with IgA Nephropathy over approximately two years. Participants will either continue with their current treatment or switch to Sparsentan.See study design
What are the potential side effects?
Potential side effects include allergic reactions to medication ingredients, changes in liver enzymes leading to jaundice or hepatitis, elevated potassium levels which could affect heart rhythm and muscle function, and possible interactions with other drugs.
PROTECT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My kidney function is at a safe level for the trial.
PROTECT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 110 postrandomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 110 postrandomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Urine protein/creatinine ratio (UP/C) at Week 36
Secondary outcome measures
eGFR over a 104-week period
eGFR over a 110-week period
eGFR over a 52-week period
PROTECT Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: sparsentan (Sub Study)Experimental Treatment1 Intervention
OLE Sub study: Sparsentan will be administered daily as a dose of 400-mg for a period of 12 weeks.
Group II: sparsentanExperimental Treatment1 Intervention
Double-blind: Sparsentan will be administered daily as a 200-mg oral tablet, over-encapsulated (blinded) size 00 capsule for the first 2 weeks of the study following randomization. For patients who tolerate the initial dose of 200 mg after 2 weeks will increase their dose to 400- mg and continue treatment to Week 110.
Group III: dapagliflozin + sparsentan (Sub study)Experimental Treatment2 Interventions
OLE Sub study: Dapagliflozin will be administered daily as a 5-mg oral tablet, in addition to 400-mg of Sparsentan, for a period of 12 weeks.
Group IV: irbesartanActive Control1 Intervention
Double-blind: Irbesartan will be administered daily as a 150-mg oral tablet, over-encapsulated (blinded) size 00 capsule for the first 2 weeks of the study following randomization. For patients who tolerate the initial dose of 150 mg after 2 weeks will increase their dose to 300 mg and continue treatment to Week 110.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin
2014
Completed Phase 4
~64880
Find a Location
Who is running the clinical trial?
Travere Therapeutics, Inc.Lead Sponsor
20 Previous Clinical Trials
177,256 Total Patients Enrolled
Priscila Preciado, MDStudy DirectorTravere Therapeutics, Inc.
2 Previous Clinical Trials
431 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently pregnant or breastfeeding.I do not have jaundice, hepatitis, or liver disease, and my liver tests are normal.I am willing to change my blood pressure medications if needed.I have been on a stable dose of ACEI or ARB for at least 12 weeks.I am 18 years old or older.My kidney function is at a safe level for the trial.I couldn't start or had to stop RAAS inhibitors between Week 110 and 114.I have been on a stable dose of sparsentan for at least 8 weeks.I have been taking an SGLT2 inhibitor for the last 12 weeks.My kidney disease has progressed to the point where I need dialysis.My kidney function, measured by eGFR, is at least 25.Your blood has too few red blood cells or too little hemoglobin.My kidney disease has progressed to the point where I need dialysis.I was not disqualified from the study or stopped the study medication between Week 110 and 114.You have been diagnosed with primary IgA nephropathy through a biopsy.If you had a kidney biopsy within the last 6 months, and it showed a specific kind of damage in more than 25% of the kidney samples.You have a history of problems with drinking alcohol or using illegal drugs.I haven't taken immune-weakening medications for more than 2 weeks in the last 3 months.I am allergic to certain blood pressure medications or their ingredients.Your kidney function is very low, specifically measured at less than 20 mL per minute per 1.73 square meters of body surface area at week 110.Your urine has a high level of protein, equal to or more than 0.3 grams per day.I have had an organ transplant, but not of the cornea.I have started or changed the dose of a medication to suppress my immune system in the last 12 weeks.I am not pregnant, planning to become pregnant, or breastfeeding during the study.Your blood pressure should not be higher than 150 over 100 at the screening.I have a history of heart failure or symptoms like unexplained shortness of breath.I haven't had a stroke or significant heart disease in the last 6 months.You have more than 1 gram of protein in your urine every day during screening.Your potassium level is higher than 5.5 mEq/L at the screening.I have chronic kidney disease and IgA nephropathy.My IgA nephropathy is caused by another health condition.I haven't had cancer in the past 2 years, except for certain skin cancers or cervical cancer.
Research Study Groups:
This trial has the following groups:- Group 1: irbesartan
- Group 2: sparsentan
- Group 3: dapagliflozin + sparsentan (Sub study)
- Group 4: sparsentan (Sub Study)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are some of the primary conditions that sparsentan is used to treat?
"Patients who have not adequately responded to previous treatment, are treatment naive, or have hypertension can be treated using sparsentan."
Answered by AI
What other research has involved sparsentan in the past?
"sparsentan was first researched in 2012 at BakerIDI Heart and Diabetes Institute. Currently, there are 9 ongoing clinical trials and 48 completed studies. The majority of the live trials are taking place in Tacoma, Washington."
Answered by AI
Are there reports of adverse effects associated with sparsentan?
"Sparsentan's safety was evaluated as a 3 by our team at Power. This is due to the fact that this drug is in Phase 3 trials, which suggests that there is both anecdotal evidence and multiple rounds of data supporting the efficacy and safety of the medication."
Answered by AI
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