ClinicaliQ Trial Snapshot
- A Study of the Safety and Activity of Sparsentan for the Treatment of Patients With Immunoglobulin A Nephropathy — Recruiting • Phase II • NCT04663204.
- What is being tested: Sparsentan, a dual endothelin and angiotensin II receptor antagonist, is being evaluated for its nephroprotective efficacy and safety in patients with immunoglobulin A nephropathy (IgAN), comparing incident patients Phase IIïve to ACEI/ARB therapy against those with prior conventional….
- Patient eligibility overview: The trial enrolls two cohorts—treatment-Phase IIïve newly-diagnosed IgAN patients (Cohort A) and those with prior ACEI/ARB exposure (Cohort B)—allowing assessment of sparsentan's benefit across different treatment histories and disease stages.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- For Cohort A (Patients with Incident IgAN) Inclusion Criteria: * The patient is willing and able to provide signed informed consent. * The patient can understand written and spoken English. * The patient is male or female, aged ≥18 years. * The patient has been diagnosed with biopsy-proven IgAN within the last 6 months (calculated from the date of kidney biopsy, upon which the IgAN-positive diagnosis was made, to the signing of the informed consent form). * The patient has a urine total protein value ≥0.5 g/day at screening. * The patient has an eGFR value ≥30 mL/min/1.73 m2 at screening. * The patient has not previously been treated with ACEI and/or ARB therapy for IgAN OR has not received ACEI and/or ARB therapy within the last 12 months. * The patient has a systolic BP ≤150 mmHg and ≥100 mmHg, and diastolic blood pressure ≤100 mmHg and ≥60 mmHg at screening. * Women of childbearing potential (WOCBP), beginning at menarche, must agree to the use of one highly reliable (ie, can achieve a failure rate of
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.