Clin2
NCT04557462Possibly a fitRecruiting

Long-term safety study of iptacopan for IgA nephropathy

Primary IgA Nephropathy

Treatments studied

Part of Immune system & allergy, Kidney & urinary, Women’s health & pregnancy clinical trials.

This study provides continuing treatment with iptacopan for people with IgA nephropathy who have completed a previous iptacopan trial. It aims to see how safe and tolerable the drug is over a longer period.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 3
Enrollment
540 people
Ages
18 years to 100 years
Study type
Interventional

Who can take part

  • You must have completed a previous iptacopan study for IgA nephropathy.
  • Your kidney function must be at least 20 ml/min/1.73m2.
  • You need to be up to date on vaccines for meningitis, pneumonia, and Haemophilus influenzae.
  • You must be on a supportive care regimen with ACE inhibitors or ARBs, or have a documented allergy or intolerance to these medications.
  • You cannot have any other significant urinary tract disorders besides IgA nephropathy.
  • You cannot have had acute kidney injury within the last 4 weeks or a rapid decline in kidney function within the last 3 months.
  • You cannot have used immunosuppressive drugs or systemic corticosteroids within the last 90 days (or 180 days for rituximab).

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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