CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 365 enrolled
Drug / intervention
Nefecon +1 moredrug
Likely dose
Nefecon 16 mgfrom 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/NCT03643965
NCT03643965Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy at Risk of Progressing to End-stage Renal Disease (NefIgArd)

Calliditas Therapeutics AB·interventional·Posted Aug 23, 2018·Updated Dec 3, 2024

In Brief

A Phase 3 clinical trial evaluating Nefecon and Placebo oral capsule for Primary IgA Nephropathy. Completed, enrolled 365 participants across 142 sites in 19 countries.

Detailed Summary

The overall aim of the study is to evaluate the efficacy, safety, and tolerability of Nefecon 16 mg per day in the treatment of patients with primary IgAN (Immunoglobulin A nephropathy) at risk of progressing to end-stage renal disease (ESRD), despite maximum tolerated treatment with renin-angiotensin system (RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II type I receptor blockers (ARBs).

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, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedAug 23, 2018
Enrollment StartSep 5, 2018
Primary CompletionJul 10, 2023
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 7.9 years ago

Interventions

Nefecondrug

Nefecon 16 mg for daily administration by mouth for 9 months.

Placebo oral capsuledrug

Placebo capsules for daily administration by mouth for 9 months.