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

An Open-label Extention (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301 in China

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Primary Immunoglobulin A Nephropathy (IgAN)
• Intervention / Treatment: Drug: Nefecon

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.

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yuan Liu; Phone Number: 00862180123250; Email: yuan.liu@everestmedicines.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Peking University First Hospital
      • Contact: Jicheng Lv, Doctor degree; Phone Number: 00861083572611; Email: chenglv@263.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nefecon active treatment; Nefecon 16mg once daily for 9 months.	Drug: Nefecon; Nefecon is taken orally as capsules once daily for 9 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Everest Medicines (Singapore) Pte. Ltd.
• Investigators: Principal Investigator: Jicheng Lv, Doctor degree, Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Nephritis; Glomerulonephritis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Glomerulonephritis, IGA
• Other Study ID Numbers: ES103002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No