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 (IC-MPGN)

Conditions

Idiopathic Immune Complex Mediated Membranoproliferative Glomerulonephritis (IC-MPGN)

Brief summary

Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection) at 6 months.

Detailed description

Change from baseline in eGFR at 12 months. Annualized total eGFR slope estimated over 12 months., Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection) at 12 months., Change from baseline to 12 months in the Functional Assessment of chronic Illness Therapy-Fatigue (FACIT-Fatigue) score., Occurrence of clinically significant vital signs (mean sitting diastolic blood pressure [msSBP], heart rate, electrocardiograms (ECG), and safety laboratory measurements, as well as adverse events (AEs), AEs of special interest, and study drug discontinuation due to an AE (or any safety issue) during the double-blind period of the study., Additional cardiovascular safety surveillance-performed only in adolescent patients includes the evaluation of iptacopan’s potential effects on heart rate, systolic and diastolic blood pressures, cardiac function, and a cardiac biomarker throughout the double-blind and open label treatment periods., Proportion of participants who achieved the composite renal endpoint at 6 months, Proportion of participants who achieved the composite renal endpoint at 12 months.

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGPlacebo 0 mg hard gelatin capsule size 0

DRUG(placebo to LNP023 200 mg)

DRUGIPTACOPAN

DRUGIPTACOPAN HYDROCHLORIDE

DRUGPlacebo 0 mg hard gelatin capsule size 1

DRUG(placebo to LNP023 100 mg)

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection) at 6 months.	—

Secondary

Measure	Time frame
Change from baseline in eGFR at 12 months. Annualized total eGFR slope estimated over 12 months., Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection) at 12 months., Change from baseline to 12 months in the Functional Assessment of chronic Illness Therapy-Fatigue (FACIT-Fatigue) score., Occurrence of clinically significant vital signs (mean sitting diastolic blood pressure [msSBP], heart rate, electrocardiograms (ECG), and safety laboratory measurements, as well as adverse events (AEs), AEs of special interest, and study drug discontinuation due to an AE (or any safety issue) during the double-blind period of the study., Additional cardiovascular safety surveillance-performed only in adolescent patients includes the evaluation of iptacopan’s potential effects on heart rate, systolic and diastolic blood pressures, cardiac function, and a cardiac biomarker throughout the double-blind and open label treatment periods., Proportion of participants who achieved	—

Measure

Time frame

Change from baseline in eGFR at 12 months. Annualized total eGFR slope estimated over 12 months., Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection) at 12 months., Change from baseline to 12 months in the Functional Assessment of chronic Illness Therapy-Fatigue (FACIT-Fatigue) score., Occurrence of clinically significant vital signs (mean sitting diastolic blood pressure [msSBP], heart rate, electrocardiograms (ECG), and safety laboratory measurements, as well as adverse events (AEs), AEs of special interest, and study drug discontinuation due to an AE (or any safety issue) during the double-blind period of the study., Additional cardiovascular safety surveillance-performed only in adolescent patients includes the evaluation of iptacopan’s potential effects on heart rate, systolic and diastolic blood pressures, cardiac function, and a cardiac biomarker throughout the double-blind and open label treatment periods., Proportion of participants who achieved

—

Countries

Czechia, Denmark, France, Germany, Greece, Italy, Netherlands, Poland, Slovakia, Spain

Outcome results

None listed