Last updated on May 2019

Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: IgA nephropathy
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Female or male patients 18 years
  2. Biopsy-verified IgA nephropathy
  3. Stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) at the maximum allowed dose or Maximum Tolerated Dose (MTD) according to the 2012 KDIGO (Kidney Disease: Improving Global Outcomes) guidelines
  4. Urine protein creatinine ratio 1 g/24hr
  5. eGFR 45 mL/min per 1.73 m2 and 90 mL/min per 1.73 m2 using the Chronic Kidney Diseae Epidemiology Collaboration (CKD-EPI) formula
  6. Willing and able to give informed consent

Exclusion Criteria:

  1. Systemic diseases that may cause mesangial IgA deposition.
  2. Patients who have undergone a kidney transplant.
  3. Patients with acute or chronic infectious disease including hepatitis, tuberculosis, human immunodeficiency virus (HIV), and chronic urinary tract infections.
  4. Patients with liver cirrhosis, as assessed by the Investigator.
  5. Patients with a diagnosis of type 1 or type 2 diabetes mellitus which is poorly controlled.
  6. Patients with history of unstable angina, class III or IV congestive heart failure, and/or clinically significant arrhythmia, as judged by the Investigator;
  7. Patients with unacceptable blood pressure control defined as a blood pressure consistently above national guidelines for proteinuric renal disease, as assessed by the Investigator
  8. Patients with diagnosed malignancy within the past 5 years.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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