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

Everest Medicines

Status and phase: Active, not recruiting; Phase 3

Conditions: Primary Immunoglobulin A Nephropathy (IgAN)

Treatments: Drug: Nefecon

Study type: Interventional

Funder types: Other

Identifiers

NCT05534919

ES103002

Details and patient eligibility

About

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).

Full 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.

Enrollment: 58 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

Nefecon active treatment

Experimental group

Description:

Nefecon 16mg once daily for 9 months.

Treatment:

Drug: Nefecon