- Signed informed consent
- Age ≥18 years
- Indication for Rayaldee® treatment in accordance with the currently approved Summary of Product Characteristics (SmPC)
- Stable kidney function in the medical judgment of the investigator
Chronic Kidney Disease
RAYALDEE Non Interventional Study (NIS) on Effectiveness in ND-CKD SHPT Patients
NCT05460234 | Observational
The purpose of this study is to generate data on the effectiveness of Rayaldee® to gradually increase 25-hydroxyvitamin D (25D) safely and to a high enough magnitude to reliably reduce elevated parathyroid hormone in patients with non-dialysis chronic kidney disease. 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 25-hydroxyvitamin D (25D) safely and to a high enough magnitude to reliably reduce elevated parathyroid hormone (PTH) in patients with non-dialysis chronic kidney disease (ND-CKD). Clinical studies show that PRC is an effective, well tolerated treatment for secondary hyperparathyroidism (SHPT) in ND-CKD patients with vitamin D insufficiency or deficiency. PRC 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 me
Trial Information
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Dialysepraxis Spandau
Berlin,Germany
Tagesklinik Lehrpraxis der Charit Dialyse Apherese
Berlin,Germany
Marien Hospital HerneUniklinikum
Herne,Germany
Gim
Witten,Germany
Study Eligibility Criteria
- Parallel participation in an interventional study
- • Enrolment in a prior clinical trial with Rayaldee®
Additional Studies
Additional studies can be found at ClinicalTrials.gov