A study of the effect and safety of sparsentan in the treatment of patients with immunoglobulin A nephropathy.
A randomized, multicenter, double-blind, parallel-group, active-control study of the efficacy and safety of sparsentan for the treatment of immunoglobulin A nephropathy
Retrophin, Inc.
280 participants
Nov 1, 2018
Interventional
Conditions
Summary
IgAN is a serious, progressive disease in which 20% to 40% of patients progress to end-stage renal disease (ESRD) within 10 to 20 years of diagnosis. As most patients are diagnosed in their 20s or 30s, they face the prospect of dialysis or the need for kidney transplantation in the prime of their lives. The purpose of the study is to analyse the change in the urine protein/creatinine ratio (UP/C), based on a 24-hour urine sample at Week 36, when comparing sparsentan to irbesartan. Patients enrolled in the PROTECT study (Protocol 021IGAN17001) will be randomly assigned in a 1:1 ratio (like flipping a coin) to sparsentan or the active control (irbesartan) at the Day 1/Randomization visit. Study medication (sparsentan and irbesartan) will be administered as a single oral morning dose. The hypothesis to be tested relates to the change in proteinuria (protein in the urine) at Week 36 for sparsentan compared to irbesartan.
Eligibility
Inclusion Criteria7
- 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
- Systolic BP <=150 mmHg and diastolic BP <=100 mmHg at screening
- Agree to contraception
Exclusion Criteria17
- 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)
- History of type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus (HbA1c >8%), or nonfasting blood glucose >180 mg/dL at screening
- 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% or hemoglobin value <9 g/dL at Screening
- Potassium >5.5 mEq/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
- For male: planning to father a child during the course of the study
- Participation in a study of another investigational product within 28 days of screening
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Interventions
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 and maintain systolic blood pressure >100 mmHg and diastolic blood pressure >60 mmHg after 2 weeks will increase their dose to 400 mg at Week 3 through Week 110. If patients do not tolerate the increase in dose, they can move back down to the initial dose for the duration of the study. Patient's compliance with the treatment will be assessed. Patients will be asked to return all unused study medication at each visit.
Locations(25)
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ACTRN12618001511224