Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN (NCT05755386) | Clinical Trial Compass
RecruitingPhase 3
Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN
United States106 participantsStarted 2023-10-02
Plain-language summary
This study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis.
Who can participate
Age range12 Years – 60 Years
SexALL
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Inclusion Criteria:
* Male and female patients including adults (aged at least 18 years to ≤ 60 years) and adolescents (12 -17 years in non-EU countries at screening and 16-17 years in EU countries at screening).
* Diagnosis of idiopathic IC-MPGN as confirmed by kidney biopsy within 12 months prior to screening in adults and within 3 years of screening in adolescents (a biopsy report, review and confirmation by the Investigator is required). If such a biopsy is not available in an adult participant, this must be obtained at screening (performed and assessed locally for adults only).
* Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of renin angiotensin system inhibitors (RASi), e.g an ACEi or ARB for at least 90 days (or as according to local guidelines). The doses of other drugs administered to reduce proteinuria and control the disease including mycophenolic acids (MPAs - mycophenolate mofetil or mycophenolate sodium), corticosteroids, SGLT2 inhibitors and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization
* UPCR ≥ 1.0 g/g (≥ 113 mg/mmol) sampled from the first morning void urine sample at Day -75 and Day -15
* Estimated GFR (using the chronic kidney disease \[CKD\]-EPI formula for adult participants and modified Schwartz formula for adolescents aged 12 to 17 years) or measured GFR ≥ 30 ml/min/1.73m2 at screening and Day -15.
* Mandatory vaccination against Neisseria menin…
What they're measuring
1
Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection) at 6 months.
Timeframe: 6 months (double-blind)
2
Log-transformed ratio to baseline in UPCR at the 18-month visit (each study treatment arm)
Timeframe: 18 months
3
Log-transformed ratio to 12-month visit in UPCR at the 18-month visit in the placebo arm.