A Study of the Safety and Activity of Sparsentan for the Treatment of Incident Patients With Immunoglobulin A Nephropathy

  • STATUS
    Recruiting
  • End date
    Nov 26, 2023
  • participants needed
    10
  • sponsor
    University of Leicester
Updated on 26 January 2021

Summary

To determine the nephroprotective potential of treatment with sparsentan in 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.

Description

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-nave 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.

Details
Condition Nephropathy, Disorder of immune system, IgA nephropathy, Glomerulonephritis, Autoimmune disease, Autoimmunity, Nephritis, Kidney Disease (Pediatric), Kidney Disease, renal disease, kidney diseases, kidney disorders, nephrologic disease, kidney disorder, disease, kidney, autoimmune diseases, autoimmune disorder, autoimmune disorders, immune disorder, immune disorders, immunologic disease, immune dysfunction, immune disease, immun
Treatment sparsentan
Clinical Study IdentifierNCT04663204
SponsorUniversity of Leicester
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged 18 years or older at screening
Diagnosed with biopsy-proven IgAN within the last 3 months
Proteinuria of 0.5 g/day at screening
eGFR 30 mL/min/1.73 m2 at screening
Not previously treated with ACEI and/or ARB therapy for IgAN OR has not received ACEI and/or ARB therapy within the last 12 months
Systolic BP 150 mmHg and 100 mmHg, and diastolic blood pressure 100 mmHg and 60 mmHg at screening
Women of childbearing potential (WOCBP) to agree to contraception

Exclusion Criteria

IgAN secondary to another condition
Rapidly progressive glomerulonephritis (e.g. rapid decline in GFR and crescents on biopsy)
History of type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (haemoglobin A1c [HbA1c] >8%), or nonfasting blood glucose >10 mmol/L (180 mg/dL) at screening
History of organ transplantation, with the exception of corneal transplants
Requires any of the prohibited concomitant medications listed in protocol
Treatment with any systemic immunosuppressive medications for >2 weeks within 6 months prior to screening
History of heart failure (New York Heart Association Class II-IV) and/or previous hospitalisation for heart failure or unexplained dyspnoea, orthopnoea, paroxysmal nocturnal dyspnoea, ascites, and/or peripheral oedema
Clinically significant cerebrovascular disease (transient ischemic attack or stroke) and/or coronary artery disease (hospitalisation for myocardial infarction or unstable angina, new onset of angina with positive functional tests, coronary angiogram revealing stenosis, or a coronary revascularisation procedure) within 6 months prior to screening
Jaundice, hepatitis, or known hepatobiliary disease (including asymptomatic cholelithiasis), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times the upper limit of the normal range at screening
History of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 years
Haematocrit value <27% or haemoglobin value <90 g/L (9 g/dL) at screening
Potassium >5.5 mmol/L (5.5 mEq/L) at screening
History of alcohol or illicit drug use disorder
History of serious side effects or allergic response to any AngII or ERA, including sparsentan, or has a hypersensitivity to any of the excipients in the IMP
For females: Pregnancy, or plans to become pregnant during the course of the study, or is breastfeeding
Participation 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
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