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Long-term efficacy, safety and tolerability of LNP023 in C3G or IC-MPGN
EU CTIS ID: 2023-509343-27-00
What this study is testing
Participants enrolling from study CLNP023X2202: Primary Efficacy Objective (Cohort A - native C3G): To assess the effect of iptacopan on a 3-component composite renal endpoint in C3G participants at the 9-month visit. Primary Efficacy Objective (Cohort B - transplanted kidney with recurrent C3G): To assess the effect of iptacopan on C3 deposit score at the 6 to 9 month visit. Primary Safety Objective: To evaluate the long-term safety and tolerability of iptacopan in participants with C3G. Participants enrolling from study CLNP023B12301 or CLNP023B12302: Primary Objective: To evaluate the long-term safety and tolerability of iptacopan in participants with C3G or IC-MPGN.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants must have completed the treatment period of the CLNP023X2202, CLNP023B12301 or CLNP023B12302 study on study drug.
You likely can't join if
- Severe concurrent co-morbidities, e.g., advanced cardiac disease (New York Heart Association (NYHA) class IV), severe pulmonary arterial hypertension (WHO class IV), or any illness or medical condition that in the opinion of the investigator and sponsor is likely to prevent the patient from safely tolerating iptacopan or complying with the requirements of the study.
- Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to screening, or The presence of fever ≥ 38oC (100.4oF) within 7 days prior to screening.
- History of human immunodeficiency virus (HIV) or any other immunodeficiency disease.
- History or current diagnosis of ECG abnormalities indicating significant risk of safety for participants.
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- Brazil
- China
- Switzerland
- Israel
- Vietnam
- Turkey
- India
- Canada
- United States
- Japan
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; Brazil; China; Switzerland; Israel; Vietnam and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.