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

Chronic Kidney Disease Clinical Trial

— PORTRAY  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05460234
• Other study ID #: CS-RAY-2021-0421
• Status: Active, not recruiting
• Start date: October 5, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: April 2024
• Source: Vifor Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 (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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: September 30, 2025
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hyperparathyroidism
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Germany	Dialysepraxis Spandau - 01012	Berlin
Germany	Tagesklinik - Lehrpraxis der Charité Dialyse - Apherese -01007	Berlin
Germany	Städtisches Klinikum Braunschweig gGmbH -01006	Braunschweig
Germany	Nierenzentrum Eichstätt MVZ GmbH - 01072	Eichstätt
Germany	Universitätsklinik Greifswald Klinik und Poliklinik für Innere Medizin A -01066	Greifswald
Germany	Marien Hospital Herne-Uniklinikum - 01003	Herne
Germany	MVZ Saarpfalz GmbH - 01008	Homburg
Germany	Westpfalz-Klinikum GmbH - 01025	Kaiserslautern
Germany	Nephrologische Gemeinschaftspraxis Baumhackl & Rasche - 01028	Kulmbach
Germany	Klinikum Landshut -01002	Landshut
Germany	Universitätsklinikum Mainz - 01004	Mainz
Germany	Uniklinik Münster, Nephrologische Ambulanz - 01018	Münster
Germany	Universitätsklinikum Münster, Medizinische Klinik D - 01073	Münster
Germany	Nephrologisches Zentrum Rendsburg-Eckernförde - 01056	Rendsburg
Germany	Robert-Bosch-Krankenhaus - 01001	Stuttgart
Germany	Gim - 01013	Witten

Sponsors (1)

Lead Sponsor	Collaborator
Vifor (International) Inc.

Country where clinical trial is conducted

Germany, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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