Protect

Description

This is a 114-week,randomized, multicenter, double-blind, parallel-group, active-control study with an open-label extension period of up to 156 weeks, for a total duration of up to 270 weeks in patients with IgAN who have persistent overt proteinuria and remain at high risk of disease progression despite being on a stable dose (or doses) of an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) that is (are) a maximum tolerated dose that is at least one half of the maximum labeled dose (MLD) (according to approved labeling. Approximately 380 patients aged ≥18 years will be enrolled in the study globally. The investigational drug (sparsentan) is a dual acting angiotensin receptor blocker and endothelin receptor antagonist. The active control is irbesartan.

The purpose of the study is to evaluate the potential benefit of sparsentan on kidney function by analyzing change in proteinuria (protein in urine) and estimated glomerular filtration rate (eGFR) as compared to current standard treatment.

Patients enrolled in the PROTECT study (Protocol 021IGAN17001) will be those at high risk of progressing to renal failure. They will be randomly assigned in a 1:1 ratio to either sparsentan or irbesartan, as the active control (current standard treatment) at the Day 1 (Randomization) visit. Study medication (sparsentan and irbesartan) will be administered as a single oral morning dose.

The primary analysis is change in proteinuria (urine protein/creatinine ratio) from baseline at Week 36 in sparsentan-treated patients as compared to irbesartan-treated patients.

For more information from the sponsor, please visit their site www.iganprotect.com/

Is there compensation for this trial? Yes

Am I Eligible or this trial?

Below is the detailed inclusion and exclusion detail for the the trial. Some of these you may know and other we may need to test in order to determine if you are a good fit for the trial. If you are not sure, please fill out the form to the left and one of our researchers will call you to assist in determining this and answering any additional questions.

Inclusion Criteria:

  • Age 18 years or older at screening

  • Biopsy-proven primary IgAN

  • Proteinuria of ≥1 g/day at screening

  • eGFR ≥30 mL/min/1.73 m2 at screening

  • Currently on stable dose of ACEI and/or ARB therapy, for at least 12 weeks prior to screening (maximum tolerated dose and at least one-half of the maximum labeled dose)

  • Systolic BP ≤150 mmHg and diastolic BP ≤100 mmHg at screening

  • Willing to undergo change in ACEI and/or ARB and anti-hypertensive medications

  • Agree to contraception

Exclusion Criteria:

  • IgAN secondary to another condition

  • Presence of cellular glomerular crescents in >25% of glomeruli on renal biopsy (if biopsy available within 6 months of screening)

  • Chronic kidney disease (CKD) in addition to IgAN

  • History of organ transplantation, with exception of corneal transplants

  • Require any prohibited medications

  • Treatment of systemic immunosuppressive medications (including corticosteroids) for >2 weeks within 3 months of screening

  • History of heart failure or previous hospitalization for heart failure or unexplained dyspnea, orthopnea, paroxysmal nocturnal dyspnea, ascites, and/or peripheral edema

  • Clinically significant cerebrovascular disease or coronary artery disease within 6 months of screening

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

  • History of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 years

  • Hematocrit value <27% (0.27 V/V) or hemoglobin value <9 g/dL (90 g/L) at Screening

  • Potassium >5.5 mEq/L (5.5 mmol/L) at Screening

  • History of alcohol of illicit drug use disorder

  • History of serious side effect or allergic response to any angiotensin II antagonist or endothelin receptor antagonist, including sparsentan or irbesartan, or has a hypersensitivity to any of the excipients in the study medications

  • For female: Pregnancy, or planning to become pregnant during the course of the study, or breastfeeding

  • Participation in a study of another investigational product within 28 days of screening

 

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