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

NCT05534919 | Completed Phase 3

• 1 other identifier: ES103002
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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).

Conditions

Primary Immunoglobulin a Nephropathy (IgAN)

Outcome Measures

Primary Outcomes (3)

• Change in urine protein to creatinine ratio (UPCR) after 9 months

  The outcome is measured as urine protein to creatinine ratio (UPCR) based on 24 hour urine collections at 9 months following the first dose of Nefecon compared to baseline.following the first dose of Nefecon compared to baseline.

  9 months

• Change in estimated glomerular filtration rate(eGFR) at 9 months

  The outcome is measured as change in eGFR at 9 months following the first dose of Nefecon compared to baseline.

  9 months

• The incidence of treatment emergent adverse events

  Adverse event data collection

  from enrollment up to 12 months

Study Arms (1)

Nefecon active treatment

EXPERIMENTAL

Nefecon 16mg once daily for 9 months.

Drug: Nefecon

Interventions

Nefecon DRUG

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

Nefecon active treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 Kidney Disease: Improving Global Outcomes (KDIGO) guidelines.
• Willing and able to provide written informed consent.
• 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.
• 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 Immunoglobulin A (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.

Sponsors & Collaborators

• Everest Medicines (Singapore) Pte. Ltd.: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jicheng Lv, Doctor

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open label, single-arm study with active treatment.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open label, single-arm study with active treatment.

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 10, 2022
• Study Start: December 9, 2022
• Primary Completion: July 17, 2024
• Study Completion: July 17, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)