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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Primary Immunoglobulin A Nephropathy (IgAN)

Intervention / Treatment
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* Drug: Nefecon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is an open label, single-arm study with active treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nefecon active treatment<br>Nefecon 16mg once daily for 9 months. | Drug: Nefecon<br>* Nefecon is taken orally as capsules once daily for 9 months.<br>|

What is the study measuring?
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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 |