To determine the nephroprotective potential of treatment with sparsentan in (1: Cohort A) patients newly-diagnosed with immunoglobulin A nephropathy (IgAN) (ie, incident patients) who have not received prior angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) therapy, and in (2: Cohort B) patients with recurrent IgAN following kidney transplantation.
The patient is willing and able to provide signed informed consent.
The patient can understand written and spoken English.
The patient is male or female, aged ≥18 years.
The patient has been diagnosed with biopsy-proven IgAN within the last 6 months (calculated from the date of kidney biopsy, upon which the IgAN-positive diagnosis was made, to the signing of the informed consent form).
The patient has IgAN secondary to another condition (eg, systemic lupus erythematosus, liver cirrhosis).
The patient, in the opinion of the Investigator, has a rapidly progressive glomerulonephritis (rapid decline in GFR and crescents on biopsy).
The patient has a history of type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus (haemoglobin A1c [HbA1c] >8%), or nonfasting blood glucose >10 mmol/L (180 mg/dL) at screening.
The patient has undergone any organ transplantation, with the exception of corneal transplants.
Single group
Sparsentan
DrugTarget dose of 400 mg daily
Urine protein/creatinine ratio (UP/C) at Week 36
The primary efficacy endpoint is the change from baseline in the urine protein/creatinine ratio (UP/C), based on a 24-hour urine sample, at Week 36.
eGFR over a 52-week period
Rate of change in eGFR over a 1-year (52 week) period following the initial acute effect of therapy (ie, from 6 weeks post-initiation of investigational medicinal product (IMP) to 58 weeks post-initiation of IMP).
eGFR over a 104-week period
Rate of change in eGFR over a 2-year (104 week) period following the initial acute effect of therapy (ie, from 6 weeks post-initiation of investigational medicinal product (IMP) to 110 weeks post-initiation of IMP).
Change from baseline in proteinuria
Change from baseline in proteinuria, measured by urinary protein/creatinine ratio \[UPCR\] and 24-hour protein excretion, up to Week 114
Abnormalities in clinical laboratory assessments and vital signs
Proportion of patients with abnormalities in clinical laboratory assessments and vital signs at each visit
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University of Leicester
Lead sponsor
Travere Therapeutics, Inc.
Collaborator
