An open-label, non-randomized extension study to evaluate the long-term efficacy, safety and tolerability of iptacopan (LNP023) in subjects with C3 glomerulopathy or idiopathic immune-complex-membranoproliferative glomerulonephritis

Phase 3

Conditions: Complement Kidney Disease
Nephropathy
10029149

Registration Number: NL-OMON56390

Lead Sponsor: ovartis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 5

Inclusion Criteria

Participants must have completed the treatment period of the CLNP023X2202, or
CLNP023B12301 or CLNP023B12302 trial study on study drug.

Exclusion Criteria

• 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 >= 38C (100.4F) 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Primary Efficacy Objective (Cohort A - native C3G): To characterize the<br /><br>effect of treatment with iptacopan on a composite renal endpoint at the 9-month<br /><br>visit<br /><br>• Primary Safety Objective: To evaluate the long-term safety and tolerability<br /><br>of iptacopan in participants with C3G </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• To assess the effect of treatment with iptacopan on a 2-component composite<br /><br>renal endpoint at the 9-month visit<br /><br>• To assess the long-term effect of iptacopan on renal function in C3G<br /><br>participants at the 9-month visit<br /><br>• To assess the effect of iptacopan on proteinuria in C3G participants at the<br /><br>3-month visit<br /><br>• To describe the status of C3G disease progression based on glomerular<br /><br>histopathology in a renal biopsy at the 6- to 9-month visit<br /><br>• To evaluate the long-term effect of iptacopan on C3 at the 9-month visit<br /><br>• To assess the longer-term (>9 months of treatment in CLNP023B12001B) effects<br /><br>of iptacopan on the composite renal endpoint, renal function and C3 in C3G<br /><br>participants<br /><br>• To evaluate the pharmacokinetics of iptacopan in participants with prolonged<br /><br>treatment</p><br>