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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dialysepraxis Spandau - 01012, Berlin, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

ng/mL or nmol/L, pg/mL or pmol/L
Change in serum calcium level

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

mg/mL or nmol/L
Change in serum phosphate level

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

mg/mL or nmol/L

Sponsors and collaborators

Lead sponsor

Vifor (International) Inc.

Industry

Registry information

Official study 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

Acronym: PORTRAY

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2025
First posted: Jul 15, 2022
Registry last updated: Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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