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Chronic Kidney Disease (CKD)

RAYALDEE Non Interventional Study (NIS) on Effectiveness in ND-CKD SHPT Patients
NCT05460234 | OBSERVATIONAL

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

Trial Information
16 Sites
110 Participants
ACTIVE NOT RECRUITING
18 Years

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Dialysepraxis Spandau
Berlin,Germany
Tagesklinik Lehrpraxis der Charit Dialyse Apherese
Berlin,Germany
Stdtisches Klinikum Braunschweig gGmbH
Braunschweig,Germany
Nierenzentrum Eichsttt MVZ GmbH
Eichstätt,Germany
Universittsklinik Greifswald Klinik und Poliklinik fr Innere Medizin A
Greifswald,Germany
Marien Hospital HerneUniklinikum
Herne,Germany
MVZ Saarpfalz GmbH
Homburg,Germany
WestpfalzKlinikum GmbH
Kaiserslautern,Germany
Nephrologische Gemeinschaftspraxis Baumhackl & Rasche
Kulmbach,Germany
Klinikum Landshut
Landshut,Germany
Universittsklinikum Mainz
Mainz,Germany
Uniklinik Mnster, Nephrologische Ambulanz
Münster,Germany
Universittsklinikum Mnster, Medizinische Klinik D
Münster,Germany
Nephrologisches Zentrum RendsburgEckernfrde
Rendsburg,Germany
RobertBoschKrankenhaus
Stuttgart,Germany
Gim
Witten,Germany

Study Eligibility Criteria

Additional Studies

Additional studies can be found at ClinicalTrials.gov