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.
This multi-centre, open-label trial will explore the safety of, and response to sparsentan treatment in adult patients with biopsy-proven immunoglobulin A nephropathy (IgAN). In Cohort A, incident, renin angiotensin system (RAS) blockade-naïve patients will be included. The starting dose of sparsentan will be 200 mg/day, which will be titrated up to the target dose of 400 mg/day at Week 2. Patients who do not tolerate the target dose will have their dose reduced back to 200 or 100 mg/day; throughout the trial, patients will be maintained on the maximum allowed dose of sparsentan they can tolerate. All patients will be treated with sparsentan for a total of 110 weeks, followed by an off-treatment follow-up period of 4 weeks. Urinary protein excretion, estimated and measured glomerular filtration rate (GFR), Oxford Classification (MEST-C) for renal biopsies, magnetic resonance imaging (MRI) for renal interstitial fibrosis and cardiac function, and bioimpedance spectroscopy for total body water will be assessed. Quality of Life (QOL) will also be assessed. Treatment with additional antihypertensive agents is permitted during the trial, with the exception of angiotensin-converting enzyme inhibitors (ACEIs), aldosterone blockers, aliskiren, or angiotensin receptor blockers (ARBs). Safety will be assessed by adverse events (AEs), clinical laboratory evaluations, and vital signs. In Cohort B, patients with recurrent IgAN following kidney transplantation receiving stable standard of care (SOC) therapy, including standard immunosuppressive therapy (that includes tacrolimus) to prevent graft rejection, will be randomly assigned in a 1:1 ratio to receive sparsentan in addition to SOC therapy for 48 weeks or to remain on SOC therapy for the first 24 weeks after which sparsentan will be added to SOC therapy for the second 24 weeks of the study. All patients will stop ACEIs, ARBs, aldosterone blockers or aliskiren prior to initiating sparsentan treatment. All patients will complete a 4-week follow-up period, during which time treatment will be at the discretion of the investigator. Urinary protein excretion, estimated GFR (eGFR), Oxford Classification (MEST-C) for renal biopsies will be assessed, as well as measurement of tacrolimus levels during the trial. Safety will be assessed by adverse events (AEs), clinical laboratory evaluations, and vital signs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Target dose of 400 mg daily
Cambridge University Hospitals NHS Trust
Cambridge, England, United Kingdom
RECRUITINGNorthern Care Alliance NHS Foundation Trust - Salford Royal
Salford, England, United Kingdom
RECRUITINGRoyal Infirmary of Edinburgh & Western General Hospital
Edinburgh, Scotland, United Kingdom
RECRUITINGUniversity Hospital of wales
Cardiff, Wales, United Kingdom
RECRUITINGLeicester General Hospital, University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
RECRUITINGKing's College Hospital
London, United Kingdom
RECRUITINGUrine 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.
Time frame: 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).
Time frame: Week 58
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).
Time frame: Week 110
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
Time frame: 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
Time frame: Up to Week 114
Incidence of adverse events (AEs), serious AEs, AEs leading to discontinuation, AEs leading to death
AEs, serious AEs, AEs leading to discontinuation, AEs leading to death
Time frame: Up to Week 114
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