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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

Must not have

Female patient is pregnant or breastfeeding

Jaundice, hepatitis, or known hepatobiliary disease or elevations of transaminases (ALT/AST) >2 times upper limit of normal at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from week 6 to week 110 post randomization

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My kidney function is at a safe level for the trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently pregnant or breastfeeding.

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I do not have jaundice, hepatitis, or liver disease, and my liver tests are normal.

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I couldn't start or had to stop RAAS inhibitors between Week 110 and 114.

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My kidney disease has progressed to the point where I need dialysis.

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My kidney function, measured by eGFR, is at least 25.

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My kidney disease has progressed to the point where I need dialysis.

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I haven't taken immune-weakening medications for more than 2 weeks in the last 3 months.

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I am allergic to certain blood pressure medications or their ingredients.

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I have started or changed the dose of a medication to suppress my immune system in the last 12 weeks.

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I am not pregnant, planning to become pregnant, or breastfeeding during the study.

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I have a history of heart failure or symptoms like unexplained shortness of breath.

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I have chronic kidney disease and IgA nephropathy.

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My IgA nephropathy is caused by another health condition.

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I haven't had cancer in the past 2 years, except for certain skin cancers or cervical cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from week 6 to week 110 post randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from week 6 to week 110 post randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 6 to week 110 post randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent Change From Baseline in the Urine Protein/Creatinine (UP/C) at Week 36

Secondary study objectives

Annualized Slope of eGFR Following the Initial Acute Effect of Randomized Treatment (Chronic Slope)

Total Slope of Estimated Glomerular Filtration Rate (eGFR) Over a 110-week Period

Awards & Highlights

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.

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

~64440

0 / 16Eligibility criteria met