Calliditas Therapeutics is sponsoring the NefIgArd study, a randomized, double-blind and placebo-controlled Phase 3 study for IgA nephropathy. We will enroll up to 450 participants in the NefIgArd study.
PHASE 3 the NefIgArd Clinical STUDY
Calliditas is the only company to date that has completed a Phase 2b trial, meeting the primary endpoint with statistical significance in IgA Nephropathy patients. This Phase 2b trial is the largest placebo controlled study ever conducted with an investigational drug in IgAN patients. The NefIgArd Phase 3 study has a similar design to the Phase 2b study. The study is divided into 2 parts, a study treatment part “Part A” and a long term observational part “Part B”.
The primary endpoint in Phase 3 is identical to that of Phase 2b, namely reduction in proteinuria, and success in the NefIgArd Study will form the basis for regulatory filing for commercial market access in the US and Europe. The primary endpoint will be read out at the conclusion of Part A on the basis of the first 200 participants included in the study. All participants will then roll over into Part B, which is an observational continuation of the study.
The purpose of observational Part B part of the study is to determine whether proteinuria reduction is an acceptable marker for kidney function. The NefIgard study will end once there is sufficient data from Part B to determine this relationship.
In order to be included in the trial*, participants need to:
The study will be carried out in around 20 countries, including a large number of European countries as well as North America, Australia, South Korea and other select countries. Participants who meet the inclusion criteria will be randomly assigned to receive either 16 mg Nefecon (investigational drug) or placebo. Placebo looks like the investigational drug but has no active ingredient. 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 period. During this time participants’ renal function, measured by eGFR, will be followed. No investigational drug will be given during this period.
Successfully screened participants may be able to receive reimbursement for expenses and travel.
* More eligibility criteria can be found by clicking here.