- A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy — Recruiting • Phase III • NCT04557462.
- What is being tested: Long-term safety and tolerability of iptacopan (LNP023), a complement Factor B inhibitor, in an open-label extension program for patients with primary IgA nephropathy who have completed earlier phase trials (CLNP023X2203 or CLNP023A2301).
- Patient eligibility overview: Participants must have successfully completed either of two preceding randomised controlled trials evaluating iptacopan in primary IgA nephropathy, ensuring a defined population with established baseline safety and efficacy data.
- 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.
The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials. The open-label design of the current study is appropriate to provide study participants the opportunity to receive treatment with iptacopan until marketing authorizations are received and the drug product becomes commercially available while enabling collection of long-term safety and tolerability data for the investigational drug. Furthermore efficacy assessments conducted every 6 months will afford the opportunity to evaluate…
- : * For LNP023X2203, participants must have completed part 1 or part 2 of the trial. For LNP023A2301, participants must have completed the entire core trial defined as the full 24 month treatment period. * eGFR* ≥ 20 ml/min/1.73m2 *eGFR calculated using the CKD-EPI formula (or modified MDRD formula according to specific ethnic groups and local practice guidelines) * Per investigator's clinical judgement, the participant may benefit from receiving the open-label treatment of iptacopan 200 mg b.i.d. * Prior Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections should be up to date (i.e. any boosters required administered according to local regulations. * All participants must be on supportive care regimen of ACEi or ARB* as per KDIGO guidelines. * participants who are not taking KDIGO guideline doses because they have documented allergies or intolerance to ACEi and ARB are eligible for the study
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.