CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 119 enrolled
Drug / intervention
Nefecon 16mg dailydrug
Likely dose
Nefecon 16mg dailyfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04541043
NCT04541043Phase 3Completed
CompareCT.gov

An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301

Calliditas Therapeutics AB·interventional·Posted Sep 9, 2020·Updated Feb 10, 2025

In Brief

A Phase 3 clinical trial evaluating Nefecon 16mg daily for Primary IgA Nephropathy. Completed, enrolled 119 participants across 18 sites in 18 countries.

Detailed Summary

This is a Phase 3b, multicenter, open-label extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in patients with IgAN who have completed the Phase 3 Study Nef-301 and continue to be treated with a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs). Patients who previously received Nefecon in Study Nef-301 will receive retreatment, whereas patients who previously received placebo in Study Nef-301 will be treatment naïve to Nefecon.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary IgA Nephropathy
CountriesArgentina, Australia, Belarus, Belgium, Canada, Czechia, Finland, France, Germany, Greece, Italy, Poland, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedSep 9, 2020
Enrollment StartNov 17, 2020
Primary CompletionFeb 26, 2024
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 5.8 years ago

Interventions

Nefecon 16mg dailydrug

All study patients received Nefecon 16 mg daily for 9 months.