arrow-right-realarrow-right-whitearrow-rightback-to-topdoctordownloadfacebookinstagramlogo-markerlogo-wordmarkpodcastsearchsearch_whitetwitter
Close Modal

IgAN – Calliditas Therapeutics


Calliditas Therapeutics is conducting a clinical study with primary IgA Nephropathy (IgAN), in which you may be interested.  Below is the link to the website to determine if you are eligible.

This is a Phase 3, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of oral Nefecon compared to placebo in patients with IgAN on a background of optimized RAS inhibitor therapy. www.treatigan.com.

Listed below are key inclusion and exclusion criteria for the study.  For a more detailed list of these criteria please click here or go to www.clinicaltrials.gov study identifier: NCT03643965

Inclusion

  • 18 years of age or older
  • Diagnosed with IgAN and have had the diagnosis confirmed by a kidney tissue sample within the past 10 years;
  • On a stable dose of ACE-Inhibitor or Angiotensin Receptor Blocker (ARB) therapy for at least 3 months before starting the study:
  • Patients on a stable dose of RAS inhibitor therapy below the MTD will be permitted into the study if an attempt to reach the MTD was previously performed:
  • Proteinuria lab values that meet either of the following:
  • Proteinuria ≥1 g per day (≥1000 mg per day) in 2 consecutive measurements, or
  • UPCR ≥0.8 g/gram (≥90 mg/mmol) in 2 consecutive measurements
  • eGFR ≥ 35 mL/min per 1.73 m2 and ≤ 90 mL/min per 1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula based on medical history

Exclusion

  • Patients who have undergone a kidney transplant;
  • Patients with presence of other glomerulopathies (e.g., C3 glomerulopathy and/or diabetes nephropathy);
  • Patients who have been treated with any systemic GCSs within the 12 months before randomization except for a maximum of 3 periods of 2 weeks with the equivalent of 0.5 mg/kg prednisolone or less for non-IgAN indications;

What is the study drug:  Nefecon?

The active ingredient in Nefecon is budesonide, a potent gluccocoritcoidsteroid formulated in a capsule to be delivered to the mucosa in a restricted area of the gut, where the Peyer’s patches are located, resulting in a significant reduction in proteinuria and improvement in renal function parameters.  Budesonide has a high first-pass metabolism with formation of metabolites with very low GCS activity, limited systemic exposure, resulting and risk for steroid-related adverse effects.