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

NCT ID: NCT04541043

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-17
• Study Completion Date: 2024-02-26

Brief 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.

Detailed Description

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. During Study Nef-301 OLE, the patients and Investigators will remain blinded to treatment given in Study Nef-301.

During Study Nef-301 OLE, patients will receive Nefecon for a 9-month period. The dose may be reduced if clinically relevant adverse events (AEs) develop during the 9-month Treatment Period that the Investigator considers related to the study drug and that mandate dose reduction.

Patients will remain on a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) throughout the study. The patient will come for a follow-up visit at 12 months after first dose.

Conditions

Primary IgA Nephropathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active Nefecon treatment

Nefecon 16 mg once daily by mouth for 9 months

Group Type: EXPERIMENTAL

Nefecon 16mg daily

Intervention Type: DRUG

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

Interventions

Nefecon 16mg daily

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients that completed study Nef-301

2. 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

3. Willing and able to provide written informed consent.

4. UPCR equal to or more than 0.8 g/gram

5. eGFR equal to or more than 30 mL/min per 1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.

Exclusion Criteria

1. Systemic diseases that may cause mesangial IgA deposition.

2. Patients who have undergone a kidney transplant;

3. Patients with presence of other glomerulopathies and/or nephrotic syndrome

4. Patients with acute, chronic, or latent infectious disease including hepatitis, tuberculosis (TB), human immunodeficiency virus (HIV), and chronic urinary tract infections;

5. Patients with liver cirrhosis, as assessed by the Investigator;

6. Patients with a diagnosis of type 1 or type 2 diabetes mellitus which is poorly controlled

7. Patients with history of unstable angina, class III or IV congestive heart failure, and/or clinically significant arrhythmia, as judged by the Investigator;

8. Patients with unacceptable blood pressure control defined as a blood pressure consistently above national guidelines for proteinuric renal disease, as assessed by the Investigator.

9. Patients with diagnosed malignancy within the past 5 years.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Calliditas Therapeutics AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Philipson, MD

Role: STUDY_DIRECTOR

Calliditas Therapeutics AB

Locations

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

Countries

United States; Argentina; Australia; Belarus; Belgium; Canada; Czechia; Finland; France; Germany; Greece; Italy; Poland; South Korea; Spain; Sweden; Turkey (Türkiye); United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2020-003308-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Nef-301 OLE

Identifier Type: -

Identifier Source: org_study_id