A Study of the Safety and Activity of Sparsentan for the Treatment of Incident Patients With Immunoglobulin A Nephropathy (SPARTAN)
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|ClinicalTrials.gov Identifier: NCT04663204|
Recruitment Status : Recruiting
First Posted : December 10, 2020
Last Update Posted : December 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Immunoglobulin A Nephropathy Kidney Diseases Glomerulonephritis, IGA Glomerulonephritis Autoimmune Diseases Immune System Diseases||Drug: Sparsentan||Phase 2|
This is a single centre, open-label, single-group study to explore the safety of, and response to sparsentan treatment in incident, renin angiotensin system (RAS) blockade-naïve patients with biopsy-proven immunoglobulin A nephropathy (IgAN). The purpose is to explore sparsentan treatment as a potential first-line treatment in patients newly diagnosed with IgAN (ie, incident patients), who have thus not received prior treatment with ACEI or ARB therapy for IgAN. Response to treatment will be assessed as changes from baseline rather than comparison to another treatment, and will be based on established proteinuria endpoints (UPCR and protein excretion), and glomerular filtration rate (GFR); a number of exploratory measures will be assessed as well.
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 study, 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Centre, Open-label, Single-group Exploratory Study of the Safety and Activity of Sparsentan for the Treatment of Incident Patients With Immunoglobulin A Nephropathy|
|Actual Study Start Date :||December 10, 2020|
|Estimated Primary Completion Date :||October 2023|
|Estimated Study Completion Date :||November 2023|
Sparsentan will be administered once daily, starting at a dose of 200 mg (two 100 mg oral capsules) for the first 2 weeks of the study. Patients who tolerate the initial dose of 200 mg after 2 weeks will increase their dose to 400 mg (one 400 mg tablet). Patients who do not tolerate the target dose will have their dose reduced back to 200 or 100 mg/day; throughout the study, 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.
Target dose of 400 mg daily
Other Name: RE-021
- Urine protein/creatinine ratio (UP/C) at Week 36 [ Time Frame: 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 [ Time Frame: Week 58 ]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 [ Time Frame: Week 110 ]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 [ Time Frame: Up to Week 114 ]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 [ Time Frame: Up to Week 114 ]Proportion of patients with abnormalities in clinical laboratory assessments and vital signs at each visit
- Incidence of adverse events (AEs), serious AEs, AEs leading to discontinuation, AEs leading to death [ Time Frame: Up to Week 114 ]AEs, serious AEs, AEs leading to discontinuation, AEs leading to death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04663204
|Contact: Justyna Szklarzewicz||+44 116 258 email@example.com|
|Leicester General Hospital, University Hospitals of Leicester NHS Trust||Recruiting|
|Leicester, United Kingdom, LE5 4PW|
|Contact: Justyna Szklarzewicz +44 116 258 4351 firstname.lastname@example.org|
|Principal Investigator: Chee Kay Cheung, MBChB PhD|
|Principal Investigator:||Chee Kay Cheung, MBChB PhD||University of Leicester|