An observational study in Chronic Kidney Disease, sponsored by Vifor (International) Inc.. Completed at 16 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-15.
Sponsored by Vifor (International) Inc. (part of CSL Limited) · 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 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).
Non-interventional, prospective, multicentre, cohort study. Approximately 100 patients diagnosed with ND-CKD with SHPT being treated with ERC according to the SmPC will be included.
The scheduled total study duration is 2.5 years, with a recruitment phase of approximately 1.5 years. The individual prospective observational period per patient is scheduled to last up to 12 months, or up to 18 months for pre-treated patients. The number of observational time points for an individual patient will be dependent on the individual observational period and is assumed to be approximately every 3 months.
A patient is eligible if ERC treatment initiation can coincide with the date of patient inclusion in the study or can happen up to 6 months before patient inclusion in the study. The observational period of ERC treatment will be retrospective if it occurs before study inclusion and prospective for the period after study inclusion. The decision to initiate treatment remains with the treating physician, in line with their normal standard of care, in accordance with the SMPC.
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's enrollment of 110 is below the median of 213 across 834 observational studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Vifor (International) Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
First submitted before Vifor (International) Inc. became part of CSL Limited.
Counted across the registry records on this site, refreshed daily.
The study will enrol patients from approximately 18 sites in Germany. Male or female adult patients with a diagnosis of ND-CKD and SHPT who are due to be treated with ERC according to their physicians usual standard of care and in accordance with the SMPC are eligible.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Signed
Exclusion Criteria:
Parallel participation in an interventional study
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
data from medical records up to 3 months prior to ERC treatment start will be retrospectively collected (if available), to provide baseline data and to serve as a basis for evaluating the treatment decision. If relevant baseline data is not available within 3 months preceding treatment start, retrospective documentation can extend to up to 6 months. The observational period of ERC (both retrospective and prospective) is scheduled up to 18 months after treatment start (Protocol v2.0,06Dec2023)
Change in 25-hydroxyvitamin D (25D) and iPTH levels
ng/mL or nmol/L, pg/mL or pmol/L
Time frame: From up to 6 months prior of ERC treatment start to up to 18 months after treatment
Change in serum calcium level
mg/mL or nmol/L
Time frame: From up to 6 months prior of ERC treatment start to up to 18 months after treatment
Change in serum phosphate level
mg/mL or nmol/L
Time frame: From up to 6 months prior of ERC treatment start to up to 18 months after treatment
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data can be requested 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting
Access criteria: A research proposal must be approved by an independent review panel and the study sponsor and researchers must sign a data sharing agreement.
Ran from Oct 2022 to primary completion in Jan 2024, 15 months.
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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Renal Insufficiency, Chronic →