Vifor: RAYALDEE Non Interventional Study (NIS)
Apr 27, 2023 19:19:15 GMT
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Post by lookingforatenbagger on Apr 27, 2023 19:19:15 GMT
RAYALDEE Non Interventional Study (NIS) on Effectiveness in ND-CKD SHPT Patients (PORTRAY), ClinicalTrials.gov Identifier: NCT05460234
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 meaningful increases in serum phosphate and calcium.
To date, experience with the use of Rayaldee® results exclusively from patients from the United States and mainly from patients who have participated in clinical trials. It is therefore of major interest to observe the value of Rayaldee® in daily use outside of controlled trial settings with a larger sample size and in Europe.
Start Date: October 5, 2022
Estimated Primary Completion Date: June 1, 2024
Estimated Study Completion Date: December 1, 2025
clinicaltrials.gov/ct2/show/NCT05460234
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 meaningful increases in serum phosphate and calcium.
To date, experience with the use of Rayaldee® results exclusively from patients from the United States and mainly from patients who have participated in clinical trials. It is therefore of major interest to observe the value of Rayaldee® in daily use outside of controlled trial settings with a larger sample size and in Europe.
Start Date: October 5, 2022
Estimated Primary Completion Date: June 1, 2024
Estimated Study Completion Date: December 1, 2025
clinicaltrials.gov/ct2/show/NCT05460234
