Efficacy and Safety in Chinese Patients with Immunoglobulin a Nephropathy (IgAN) Who Have Completed Study Nef-301

NCT ID: NCT05534919

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-09
• Study Completion Date: 2024-07-17

Brief Summary

This is a Phase 3b, multicenter, open-label extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in Chinese patients who have completed Nef-301 and continue to be treated with a stable dose of Renin-angiotensin system (RAS) inhibitor therapy (Angiotensin-converting enzyme inhibitors (ACEIs) and/or Angiotensin II type I receptor blockers (ARBs).

Detailed Description

This is a Phase 3b, multicenter, open-label extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in Chinese patients with Immunoglobulin A nephropathy (IgAN) who have completed Nef 301 study and continue to be treated with a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs).

During Study open-label extension (OLE) study, patients will receive Nefecon for a 9-month period. The patient will come for a follow-up visit at 12 months after first dose.

Conditions

Primary Immunoglobulin a Nephropathy (IgAN)

Study Design

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

Study Groups

Nefecon active treatment

Nefecon 16mg once daily for 9 months.

Group Type: EXPERIMENTAL

Nefecon

Intervention Type: DRUG

Nefecon is taken orally as capsules once daily for 9 months.

Interventions

Nefecon

Nefecon is taken orally as capsules once 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 Kidney Disease: Improving Global Outcomes (KDIGO) guidelines.

3. Willing and able to provide written informed consent.

4. Urine protein to creatinine ratio (UPCR) equal to or more than 0.5 g/gram or Average proteinuria equal or more than 0.75 g/day.

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 Immunoglobulin A (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

Everest Medicines (Singapore) Pte. Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jicheng Lv, Doctor

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

ES103002

Identifier Type: -

Identifier Source: org_study_id