Efficacy and Safety in Patients With Primary IgA Nephropathy Who Have Completed Study Nef-301 (Nefigard-OLE)

Completed · Phase 3

Conditions studied: Primary IgA Nephropathy

In brief

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.

Key facts

Study ID

NCT04541043

Run by

Calliditas Therapeutics AB

People needed

119

Starts

2020-11-17

Expected to finish

2024-02-26

Last updated by the study team

2025-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients that completed study Nef-301
• On a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) at the maximum allowed dose or maximum tolerated dose according to the 2012 KDIGO guidelines
• Willing and able to provide written informed consent.
• UPCR equal to or more than 0.8 g/gram
• eGFR equal to or more than 30 mL/min per 1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.

You may not qualify if…

• Systemic diseases that may cause mesangial IgA deposition.
• Patients who have undergone a kidney transplant;
• Patients with presence of other glomerulopathies and/or nephrotic syndrome
• Patients with acute, chronic, or latent infectious disease including hepatitis, tuberculosis (TB), human immunodeficiency virus (HIV), and chronic urinary tract infections;
• Patients with liver cirrhosis, as assessed by the Investigator;
• Patients with a diagnosis of type 1 or type 2 diabetes mellitus which is poorly controlled
• Patients with history of unstable angina, class III or IV congestive heart failure, and/or clinically significant arrhythmia, as judged by the Investigator;
• Patients with unacceptable blood pressure control defined as a blood pressure consistently above national guidelines for proteinuric renal disease, as assessed by the Investigator.
• Patients with diagnosed malignancy within the past 5 years.

Where it is running

• 13 Investigator sites — Palo Alto, California, United States
• 4 Investigator sites — Buenos Aires, Argentina
• 6 Investigator sites — Melbourne, Australia
• 3 Investigator sites — Minsk, Belarus
• 4 Investigator sites — Brussels, Belgium
• 7 Investigator sites — Québec, Canada
• 6 Investigator sites — Prague, Czechia
• 2 Investigator sites — Jyväskylä, Finland
• 2 Investigator sites — Saint-Priest-en-Jarez, France
• 5 Investigator sites — Aachen, Germany
• 5 Investigator sites — Athens, Greece
• 2 Investigator sites — Milan, Italy
• 2 Investigator sites — Lodz, Poland
• 4 Investigator sites — Gyeonggi-do, South Korea
• 4 Investigator sites — Barcelona, Spain
• 3 Investigator sites — Uppsala, Sweden
• 3 Investigator sites — Kayseri, Turkey (Türkiye)
• 6 Investigator sites — Leicester, United Kingdom

Full record on ClinicalTrials.gov

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