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Chronic Kidney DiseasePORTRAYNCT05460234

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

An observational study of Chronic Kidney Disease, run by Vifor (International) Inc. at 16 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Kidney Disease
How many people
110 participants
Where
16 sitesGermany
Study dates
5 Oct 2022to 30 Jun 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • Signed informed consent
  • Age ≥18 years
  • Indication for ERC treatment in accordance with the currently approved SmPC.
  • Starting ERC treatment or being on ERC treatment for a maximum of 6 months before inclusion in the study.
  • Stable kidney function in the medical judgment of the investigator

Who cannot join

  • Parallel participation in an interventional study
  • Enrolment in a prior clinical trial with ERC

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Germany16 sites

  • Dialysepraxis Spandau - 01012

    Berlin

  • Tagesklinik - Lehrpraxis der Charité Dialyse - Apherese -01007

    Berlin

  • Städtisches Klinikum Braunschweig gGmbH -01006

    Braunschweig

  • Nierenzentrum Eichstätt MVZ GmbH - 01072

    Eichstätt

  • Universitätsklinik Greifswald Klinik und Poliklinik für Innere Medizin A -01066

    Greifswald

  • Marien Hospital Herne-Uniklinikum - 01003

    Herne

  • MVZ Saarpfalz GmbH - 01008

    Homburg

  • Westpfalz-Klinikum GmbH - 01025

    Kaiserslautern

  • Nephrologische Gemeinschaftspraxis Baumhackl & Rasche - 01028

    Kulmbach

  • Klinikum Landshut -01002

    Landshut

  • Universitätsklinikum Mainz - 01004

    Mainz

  • Uniklinik Münster, Nephrologische Ambulanz - 01018

    Münster

  • Universitätsklinikum Münster, Medizinische Klinik D - 01073

    Münster

  • Nephrologisches Zentrum Rendsburg-Eckernförde - 01056

    Rendsburg

  • Robert-Bosch-Krankenhaus - 01001

    Stuttgart

  • Gim - 01013

    Witten

Other trials in Germany

About this study

Official title: Non-interventional Study to Collect Real-world Effectiveness, Safety, and Adherence Data on Extended-release Calcifediol (Rayaldee®) in Non-dialysis CKD Patients With Secondary Hyperparathyroidism. Protocol Version 2.0, 06DEC2023

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).

Read the detailed description

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.

Keywords
hyperparathyroidism, calcifediol
Medical subject headings
Renal Insufficiency, Chronic, Hyperparathyroidism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05460234
Study groupRoleWhat they receive
Single Cohortdata 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)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in 25-hydroxyvitamin D (25D) and iPTH levels

    ng/mL or nmol/L, pg/mL or pmol/L

    Measured: From up to 6 months prior of ERC treatment start to up to 18 months after treatment

  2. Change in serum calcium level

    mg/mL or nmol/L

    Measured: From up to 6 months prior of ERC treatment start to up to 18 months after treatment

  3. Change in serum phosphate level

    mg/mL or nmol/L

    Measured: From up to 6 months prior of ERC treatment start to up to 18 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2022
  2. Study start5 Oct 2022
  3. Primary completion31 Jan 2024
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05460234
Sponsor's protocol ID
CS-RAY-2021-0421
Acronym
PORTRAY
Status last verified
Jul 2025
First submitted
8 Jun 2022
Last updated
15 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Petkovich M, Melnick J, White J, Tabash S, Strugnell S, Bishop CW. Modified-release oral calcifediol corrects vitamin D insufficiency with minimal CYP24A1 upregulation. J Steroid Biochem Mol Biol. 2015 Apr;148:283-9. doi: 10.1016/j.jsbmb.2014.11.022. Epub 2014 Nov 22.

    PubMed 25446887

  • Sprague SM, Silva AL, Al-Saghir F, Damle R, Tabash SP, Petkovich M, Messner EJ, White JA, Melnick JZ, Bishop CW. Modified-release calcifediol effectively controls secondary hyperparathyroidism associated with vitamin D insufficiency in chronic kidney disease. Am J Nephrol. 2014;40(6):535-45. doi: 10.1159/000369939. Epub 2015 Jan 7.

    PubMed 25572630

  • Sprague SM, Crawford PW, Melnick JZ, Strugnell SA, Ali S, Mangoo-Karim R, Lee S, Petkovich PM, Bishop CW. Use of Extended-Release Calcifediol to Treat Secondary Hyperparathyroidism in Stages 3 and 4 Chronic Kidney Disease. Am J Nephrol. 2016;44(4):316-325. doi: 10.1159/000450766. Epub 2016 Sep 28.

    PubMed 27676085

  • Sprague SM, Strugnell SA, Bishop CW. Extended-release calcifediol for secondary hyperparathyroidism in stage 3-4 chronic kidney disease. Expert Rev Endocrinol Metab. 2017 Sep;12(5):289-301. doi: 10.1080/17446651.2017.1347501. Epub 2017 Jul 11.

    PubMed 30058895

  • Strugnell SA, Sprague SM, Ashfaq A, Petkovich M, Bishop CW. Rationale for Raising Current Clinical Practice Guideline Target for Serum 25-Hydroxyvitamin D in Chronic Kidney Disease. Am J Nephrol. 2019;49(4):284-293. doi: 10.1159/000499187. Epub 2019 Mar 15.

    PubMed 30878999

  • Cozzolino M, Ketteler M. Evaluating extended-release calcifediol as a treatment option for chronic kidney disease-mineral and bone disorder (CKD-MBD). Expert Opin Pharmacother. 2019 Dec;20(17):2081-2093. doi: 10.1080/14656566.2019.1663826. Epub 2019 Nov 1.

    PubMed 31675257

  • Ketteler M, Ambuhl P. Where are we now? Emerging opportunities and challenges in the management of secondary hyperparathyroidism in patients with non-dialysis chronic kidney disease. J Nephrol. 2021 Oct;34(5):1405-1418. doi: 10.1007/s40620-021-01082-2. Epub 2021 Jun 25.

    PubMed 34170509

  • Cozzolino M, Minghetti P, Navarra P. Extended-release calcifediol in stage 3-4 chronic kidney disease: a new therapy for the treatment of secondary hyperparathyroidism associated with hypovitaminosis D. J Nephrol. 2022 Apr;35(3):863-873. doi: 10.1007/s40620-021-01152-5. Epub 2021 Oct 9.

    PubMed 34626363

  • Fadda G, Germain MJ, Broumand V, Nguyen A, McGarvey N, Gitlin M, Bishop CW, Ashfaq A. Real-World Assessment: Clinical Effectiveness and Safety of Extended-Release Calcifediol. Am J Nephrol. 2021;52(10-11):798-807. doi: 10.1159/000518545. Epub 2021 Oct 27.

    PubMed 34818216

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Kidney Disease, run by Vifor (International) Inc. at 16 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 25-hydroxyvitamin D (25D) and iPTH levels (time frame: From up to 6 months prior of ERC treatment start to up to 18 months after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05460234, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.

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