ClinicaliQ Trial Snapshot
- PS-002 for the Treatment of IgA Nephropathy in Adults — Recruiting • Phase I • NCT07182227.
- PS-002 is a novel therapeutic agent being tested in a first-in-human trial to evaluate its safety, tolerability, and preliminary effectiveness in treating primary IgA nephropathy, the most common primary glomerulonephritis globally.
- Eligible participants are adults with primary IgA nephropathy at high risk of disease progression, though specific inclusion/exclusion criteria should be reviewed as this summary indicates further detail is available.
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
The purpose of the study is to evaluate safety, tolerability, and preliminary effectiveness following administration of PS-002 in adults with primary Immunoglobulin A (IgA) nephropathy. This will be a first-in-human study and will include participants at high risk of disease progression despite receiving current standard-of-care treatment. Participants will be monitored for up to one year after receiving PS-002 and invited to take part in a long-term follow-up study (total follow-up: 5 years).
Eligibility Snapshot
- : * Diagnosis of primary IgA nephropathy (IgAN) as evidenced by renal biopsy. * A historic kidney biopsy performed within 36 months prior to screening with reported evidence of complement component 3 (C3) deposition. If the participant had a kidney biopsy performed over 36 months prior to Screening, a new kidney biopsy should be carried out during the Screening period. This biopsy must exhibit signs of ongoing complement system activity. * Proteinuria as assessed at the Screening visit by UPCR at least 1g/g (at least 1000 mg/g) OR total protein excretion at least 1 g/24 h (at least 1000 mg/24h) sampled from 24 h urine collection. * eGFR calculated using the CKD-EPI formula at least 45 mL/min/1.73m^2. * Sitting office systolic blood pressure equal to or less than 140 mmHg, diastolic blood pressure equal to or less than 90 mmHg. * All participants must have been on best supportive care for IgAN, as per region-specific requirements defined in the protocol.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.