A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy

  • STATUS
    Recruiting
  • End date
    Apr 5, 2023
  • participants needed
    380
  • sponsor
    Retrophin, Inc.
Updated on 5 November 2020
Investigator
Retrophin Medical Information
Primary Contact
Retrophin Investigational Site (0.0 mi away) Contact
+137 other location
angiotensin
immunoglobulins
proteinuria
immunoglobulin a

Summary

To determine the long-term (approximately 2 years) nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with immunoglobulin A nephropathy (IgAN).

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.

Details
Treatment Irbesartan, sparsentan
Clinical Study IdentifierNCT03762850
SponsorRetrophin, Inc.
Last Modified on5 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Glomerulonephritis or Autoimmune disease or IgA nephropathy?
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
Key Inclusion Criteria for the Open-Label Extension Period based on
assessments at the Week 110 visit
Completed participation in the double-blind period, including the Week 114 visit
Did not permanently discontinue study medication during the double-blind period
Agree to contraception
Key Exclusion Criteria for the Open-Label Extension Period based on
assessments at the Week 110 and Week 114 visits
Progression to end-stage renal disease (ESRD) requiring renal replacement therapy (RRT)
Development of any criteria for discontinuation of study medication or discontinuation from the study, between Week 110 and Week 114
Patient was unable to initiate, or developed contraindications to, treatment with RAAS inhibitors between Week 110 and Week 114
eGFR 20 mL/min/1.73 m2 at Week 110
Female patient is pregnant or breastfeeding
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