Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.
ConditionC3G
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-60
SponsorNovartis Pharmaceuticals
About this trial
The Primary Completion Date and Study Completion Date have been updated to reflect completion of the adolescent cohort, which has been added to the protocol.
The study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy.
Eligibility criteria
Qualifiers
Male and female participants age ≥ 12 and ≤ 60 years at screening.
Diagnosis of C3G as confirmed by renal biopsy within 12 months prior to enrollment in adults and within 3 years in adolescents.
Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) for at least 90 days. The doses of other antiproteinuric medications including mycophenolic acid, corticosteroids and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization.
Reduced serum C3 (defined as less than 0.85 x lower limit of the central laboratory normal range) at Screening.
Disqualifiers
Participants who have received any cell or organ transplantation, including a kidney transplantation.
Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with renal biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli.
Renal biopsy showing interstitial fibrosis/tubular atrophy (IF/TA) of more than 50%
Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care.
Trial design
Treatments tested in this trial
- Placebo
- iptacopan
Treatment groups
98 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov