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

NCT05460234 | Completed DMC

• 1 other identifier: CS-RAY-2021-0421
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 16

Brief 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

Chronic Kidney Disease

Keywords

hyperparathyroidism; calcifediol

Outcome Measures

Primary Outcomes (3)

• Change in 25-hydroxyvitamin D (25D) and iPTH levels

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

  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

  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

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

Study Arms (1)

Single Cohort

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Signed informed consent
• Age ≥18 years
• Indication for ERC treatment in accordance with the currently approved SmPC.
• Stable kidney function in the medical judgment of the investigator

You may not qualify if:

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

Sponsors & Collaborators

• Vifor (International) Inc.: lead

Study Sites (16)

Dialysepraxis Spandau - 01012

Berlin, Germany

Location

Tagesklinik - Lehrpraxis der Charité Dialyse - Apherese -01007

Berlin, Germany

Location

Städtisches Klinikum Braunschweig gGmbH -01006

Braunschweig, Germany

Location

Nierenzentrum Eichstätt MVZ GmbH - 01072

Eichstätt, Germany

Location

Universitätsklinik Greifswald Klinik und Poliklinik für Innere Medizin A -01066

Greifswald, Germany

Location

Marien Hospital Herne-Uniklinikum - 01003

Herne, Germany

Location

MVZ Saarpfalz GmbH - 01008

Homburg, Germany

Location

Westpfalz-Klinikum GmbH - 01025

Kaiserslautern, Germany

Location

Nephrologische Gemeinschaftspraxis Baumhackl & Rasche - 01028

Kulmbach, Germany

Location

Klinikum Landshut -01002

Landshut, Germany

Location

Universitätsklinikum Mainz - 01004

Mainz, Germany

Location

Uniklinik Münster, Nephrologische Ambulanz - 01018

Münster, Germany

Location

Universitätsklinikum Münster, Medizinische Klinik D - 01073

Münster, Germany

Location

Nephrologisches Zentrum Rendsburg-Eckernförde - 01056

Rendsburg, Germany

Location

Robert-Bosch-Krankenhaus - 01001

Stuttgart, Germany

Location

Gim - 01013

Witten, Germany

Location

Related Publications (9)

• 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.

  PMID: 25446887 BACKGROUND

• 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.

  PMID: 25572630 BACKGROUND

• 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.

  PMID: 27676085 BACKGROUND

• 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.

  PMID: 30058895 BACKGROUND

• 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.

  PMID: 30878999 BACKGROUND

• 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.

  PMID: 31675257 BACKGROUND

• 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.

  PMID: 34170509 BACKGROUND

• 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.

  PMID: 34626363 BACKGROUND

• 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.

  PMID: 34818216 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperparathyroidism

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Parathyroid Diseases; Endocrine System Diseases

Study Officials

• Markus Ketteler, Prof.

  Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: July 15, 2022
• Study Start: October 5, 2022
• Primary Completion: January 31, 2024
• Study Completion: June 30, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.

Locations

DE (16)