Efficacy and Safety in Patients With Primary IgA Nephropathy Who Have Completed Study Nef-301 (Ne… (NCT04541043) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety in Patients With Primary IgA Nephropathy Who Have Completed Study Nef-301 (Nefigard-OLE)
United States, Argentina, Australia119 participantsStarted 2020-11-17
Plain-language summary
This is a Phase 3b, multicenter, open-label extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in patients with IgAN who have completed the Phase 3 Study Nef-301 and continue to be treated with a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs). Patients who previously received Nefecon in Study Nef-301 will receive retreatment, whereas patients who previously received placebo in Study Nef-301 will be treatment naïve to Nefecon.
Who can participate
Age range18 Years
SexALL
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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 KDIGO guidelines
✓. Willing and able to provide written informed consent.
✓. UPCR equal to or more than 0.8 g/gram
✓. 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 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;
What they're measuring
1
Ratio of Urine Protein to Creatine Ratio (UPCR) at 9 Months Compared to Baseline
Timeframe: 9 months
2
Ratio of Estimated Glomerular Filtration Rate (eGFR) at 9 Months Compared to Baseline
✕. Patients with unacceptable blood pressure control defined as a blood pressure consistently above national guidelines for proteinuric renal disease, as assessed by the Investigator.