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

E

Everest Medicines (Singapore) Pte. Ltd.

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

  • 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

58 participants in 1 patient group

Nefecon active treatment
Experimental group
Description:
Nefecon 16mg once daily for 9 months.
Treatment:
Drug: Nefecon

Trial contacts and locations

1

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Central trial contact

Yuan Liu

Data sourced from clinicaltrials.gov

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