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

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Leicester
• Collaborator: Travere Therapeutics, Inc.

Criteria

Key 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

Key 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.