Immunoglobulin A (IgA) nephropathy MedDRA version: 20.0 Level: PT Classification code 10021263 Term: IgA nephropathy System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Product Name: Sparsentan
Product Code: RE-021
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Sparsentan
CAS Number: 254740-64-2
Current Sponsor code: RE-021
Other descriptive name: SPARS
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patient is willing and able to provide signed informed consent • Patient can understand written and spoken English. • Male and female patients with IgAN aged =18 years • Biopsy-proven IgAN, diagnosed within the past 3 months • Urine total protein =0.5 g/day and estimated glomerular filtration rate (eGFR) value =30 mL/min/1.73 m2 • Not previously treated with ACEI and/or ARB therapy OR not treated with ACEI and/or ARB therapy within the past 12 months • Women of childbearing potential (WOCBP), beginning at menarche, must agree to the use of one highly reliable (ie, can achieve a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: • Secondary cause of IgAN • Rapidly progressive glomerulonephritis • History of diabetes mellitus or nonfasting blood glucose >10 mmol/L (180 mg/dL) • Organ transplantation (with the exception of corneal transplants) • Concomitant or recent immunosuppression • History of heart failure (NYHA Class II-IV), clinically significant cerebrovascular disease, or coronary artery disease • Jaundice, hepatitis, or known hepatobiliary disease • Malignancy within the past 2 years • Haematocrit 5.5 mmol/L (5.5 mEq/L) • History of alcohol or illicit drug use disorder (as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) • History of serious side effects or allergic response to any angiotensin II antagonist or endothelin receptor antagonist (ERA) • The female patient is pregnant, plans to become pregnant during the course of the study, or is breastfeeding. • The patient has participated in a study of any investigational product within 28 days prior to screening, or plans to participate in such a study during the course of this study. • The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the study, including the ability to swallow the IMP whole. • The patient, in the opinion of the Investigator, has a medical condition or abnormal clinically significant laboratory screening value not listed above that may interfere with the evaluation of sparsentan safety or activity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The efficacy objective of the study is to determine the effect of sparsentan on proteinuria and renal function, in patients newly diagnosed with Immunoglobulin A Nephropathy (IgAN) who are treatment-naive. The exploratory objective of the study is to determine whether sparsentan has a beneficial effect in patients with IgAN on changes in the kidney tissue by biopsy, quality of life, kidney scarring, cardiac function, blood pressure and other factors measured in the blood. The safety objective of the study is to assess the safety and tolerability of sparsentan by monitoring of safety endpoints.;Secondary Objective: Not applicable;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: Week 36 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The rate of change in eGFR over a 52-week (approximately 1-year) period following the initial acute effect of therapy (the initial acute effect of therapy is defined as the first 6 weeks of randomised treatment with study medication; thus, the analysis is from 6 weeks post randomisation to 58 weeks post randomisation) The rate of change in eGFR over a 104-week (approximately 2-year) period following the initial acute effect of therapy (the initial acute effect of therapy is defined as the first 6 weeks of randomised treatment with study medication; thus, the analysis is from 6 weeks post randomisation to 110 weeks post randomisation) Achievement of urinary protein excretion, based on a 24-hour urine sample, =0.3 g/day at Week 36 The mean change from baseline over time in selected proteinuria variables, based on a 24-hour urine sample (eg, total urine protein, total urine albumin, urine albumin/creatinine ratio [UA/C]), up to Week 110 The proportion of patients reaching a confirmed 40% change in eGFR, end-stage renal disease (ESRD), or death. (ESRD is defined as initiation of renal replacement therapy [RRT], kidney transplantation, or sustained eGFR <15 mL/min/1.73m2.) Proportion of patients with abnormalities in clinical laboratory assessments and vital signs at each visit Proportion of patients with AEs, serious AEs, AEs leading to discontinuation, AEs leading to death Mean change from baseline in haematuria at each visit Change from the diagnostic (baseline) renal biopsy at Week 24, according to the Oxford Classification (MEST-C) Change from baseline in GFR based on measured GFR (mGFR; 51CR-EDTA method), up to Week 110 Comparison of eGFR and mGFR, up to Week 110 Change from baseline in total body water, as measured by bioimpedance spectroscopy, up to Weeks 110 Mean changes from baseline in quality of life (QOL), measured via patient-reported outcome (PRO) up to Week 110 Change from baseline in the degree of renal interstitial f | — |
Countries
United Kingdom
Contacts
Public ContactDr Chee Kay Cheung
University of Leicester
Outcome results
None listed