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Active Clinical Trials

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

Active NCT:
03643965
West Penn Hospital
West Penn Hospital

Sponsor: 
Calliditas Therapeutics AB
Contact: 

For more information, please contact Susan Hebda by telephone at 412-578-5011 or email at Susan.Hebda@ahn.org.

A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd)

Purpose: 

The overall aim of the study is to evaluate the efficacy, safety, and tolerability of Nefecon 16 mg per day in the treatment of patients with primary IgAN (Immunoglobulin A nephropathy) at risk of progressing to end-stage renal disease (ESRD), despite maximum tolerated treatment with renin-angiotensin system (RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II type I receptor blockers (ARBs).

Ages Eligible for Study:  18 Years and older   (Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

Inclusion Criteria:

Female or male patients ≥18 years

Biopsy-verified IgA nephropathy

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

Urine protein creatinine ratio ≥1 g/24hr

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

Willing and able to give informed consent

Exclusion Criteria:

Systemic diseases that may cause mesangial IgA deposition.

Patients who have undergone a kidney transplant.

Patients with acute or chronic infectious disease including hepatitis, tuberculosis, 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.