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

NCT05460234 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2025-07-15

No results posted yet for this study

Summary

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 the US and mainly from patients who have participated in clinical trials. It is therefore of major interest to observe the value of ERC in daily use outside of the controlled trial settings in the US as well as in Europe. (Protocol v.2.0,06Dec2023).

Conditions

Sponsors & Collaborators

  • Vifor (International) Inc.

    lead INDUSTRY

Principal Investigators

  • Markus Ketteler, Prof. · Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-05
Primary Completion
2024-01-31
Completion
2025-06-30

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05460234 on ClinicalTrials.gov