A multicenter rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathy who have completed a Novartis-sponsored iptacopan parent study in IgAN

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508690-92-00

Acronym

CLNP023A2002B

Enrollment

100

Registered

2024-05-02

Start date

2021-09-20

Completion date

Unknown

Last updated

2025-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgA Nephropathy

Brief summary

Safety and tolerability endpoints (including but not limited to AEs/SAEs, safety laboratory parameters, vital signs).

Detailed description

Annualized total eGFR slope., Change from baseline in eGFR., Log transformed ratio to baseline in UPCR, UACR.

Interventions

DRUG-

DRUGIPTACOPAN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Safety and tolerability endpoints (including but not limited to AEs/SAEs, safety laboratory parameters, vital signs).	—

Secondary

Measure	Time frame
Annualized total eGFR slope., Change from baseline in eGFR., Log transformed ratio to baseline in UPCR, UACR.	—

Countries

Belgium, Czechia, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Slovakia, Slovenia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026