Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN

Conditions

• IC-MPGN

Eligibility Criteria

Sex

ALL

Age

12 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  Placebo to iptacopan 200mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)
• iptacopan — DRUG
  iptacopan 200 mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)

Study Details

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.

Key Dates

Start date

Oct 2, 2023

Status verified

May 2026

Primary completion

Oct 27, 2028

Completion

May 31, 2029

Study Design

Enrollment

106 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: iptacopan 200mg b.i.d
  iptacopan 200mg b.i.d
• Placebo Comparator: Placebo to iptacopan 200mg b.i.d.
  Placebo to iptacopan 200mg b.i.d.

Primary Outcome Measure

Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection) at 6 months. [ Time Frame: 6 months (double-blind) ]

Central Contacts

• Novartis Pharmaceuticals
  1-888-669-6682
  [email protected]
• Novartis Pharmaceuticals
  +41613241111

Locations (22)

Find similar trials in Los Angeles, CA

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