The NefIgArd Study
Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy
This clinical trial will evaluate the efficacy of Nefecon compared to matching placebo in patients with primary IgAN on a background of optimized RAS inhibitor therapy.
Trial for people with
Primary IgA Nepropathy
To determine if Nefecon reduces proteinuria in patients with IgAN, and as a result in long term delaying the disease progression.
What is involved for the Patient?
Eligible participants will be randomly assigned to receive either 16 mg Nefecon or placebo. During Part A, participants will be asked to take their medication in the form of capsules to be swallowed by mouth once daily for 9 months. All participants included in the study will continue into Part B, which is an observational long-term follow up. During this time participants’ renal function will be followed. No investigational drug will be given during this period.
About the drug or intervention
Nefecon is a new oral formulation of budesonide that is designed to specifically deliver the drug to a place in the intestine where most of the immune cells producing IgA are located.
- Study CoordinatorLaurie Lowdermilk (Marino)
- Study Coordinator Emaillmarino@mtnkidney.com
- Study Coordinator Phone828.258.8545
- Site NameMountain Kidney & Hypertension Associates, P.A.
- Address10 McDowell St, Asheville, NC, 28801
- SponsorCalliditas Therapeutics AB
- Study DrugNefecon
- Estimated enrollment450
- Estimated end dateDecember 2024