- * Signed informed consent
- * Age ≥18 years
- * Indication for ERC treatment in accordance with the currently approved SmPC.
- * Starting ERC treatment or being on ERC treatment for a maximum of 6 months before inclusion in the study.
- * Stable kidney function in the medical judgment of the investigator
Chronic Kidney Disease (CKD)
The overall study objective is to collect real-world data on the safety and effectiveness of ERC to gradually increase 25D to the level required by Stage 3 and 4 CKD patients. ERC (Rayaldee), a prolonged-release calcifediol (PRC) formulation, is an orally administered prohormone of active Vitamin D (1,25-dihydroxyvitamin D (1,25D)) designed to increase serum total 25D safely and to a high enough magnitude to reliably reduce elevated PTH in patients with non-dialysis chronic kidney disease (ND-CKD). Clinical studies show that ERC is an effective, well tolerated treatment for secondary hyperparathyroidism (SHPT) in ND-CKD patients with Vitamin D insufficiency or deficiency. ERC gradually raises serum 25D levels, resulting in physiologically regulated increases in serum 1,25D and sustained and progressive reductions in PTH levels, while avoiding clinically meaningful increases in serum phosphate and calcium. To date, experience with the use of ERC results exclusively from patients from
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Study Eligibility Criteria
Additional Studies
Additional studies can be found at ClinicalTrials.gov