NCT03643965

Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 365 (actual)
• Sponsor: Calliditas Therapeutics AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of oral Nefecon compared to matching placebo in patients with primary IgAN on a background of optimized RAS inhibitor therapy. The study will consist of 2 parts, Part A and Part B. Part A will include a 9 month blinded Treatment Period, and a 3-month Follow up Period. Part B of the study will consist of a 12-month observational Follow up Period; no study drug will be administered during Part B. Part A and B will be blinded. Safety will be monitored by an independent Data Safety Monitoring Board.

Conditions

• Primary IgA Nephropathy

Interventions

Type	Name	Description
DRUG	Nefecon	Nefecon 16 mg for daily administration by mouth for 9 months.
DRUG	Placebo oral capsule	Placebo capsules for daily administration by mouth for 9 months.

Timeline

• Start date: 2018-09-05
• Primary completion: 2023-07-10
• Completion: 2023-07-10
• First posted: 2018-08-23
• Last updated: 2024-12-03
• Results posted: 2024-12-03

Locations

142 sites across 19 countries: United States, Argentina, Australia, Belarus, Belgium, Canada, Czechia, Finland, France, Germany, Greece, Italy, Poland, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study