Evidence map›Paper›PMID 34626363›Full record

ReviewJournal of nephrology2022

Extended-release calcifediol in stage 3-4 chronic kidney disease: a new therapy for the treatment of secondary hyperparathyroidism associated with hypovitaminosis D.

Mario Cozzolino, Paola Minghetti, Pierluigi Navarra

Registry-linked trialOpen access · hybridAbstract readReview
In one paragraph

Review in Journal of nephrology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05460234 (Non-interventional Study to Collect Real-world Effectiveness, Safety, and Adherence Data on Extended-release Calcifediol), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.0field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05460234 completednot on this map

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

TypeobservationalSponsorVifor (International) Inc.Ran2022 to 2025Enrolled110ConditionsChronic Kidney Disease
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 18 citations in OpenAlex.

  1. Vitamin D: are all compounds equal?Clinical kidney journal · 2025
    Article
  2. Review
  3. Article
  4. Review
  5. Article
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 3 institutions in 2 countries.

Mario CozzolinoRenal Division, ASST Santi Paolo e Carlo, Department of Health Sciences, University of Milan, Milan, Italy. mario.cozzolino@unimi.it.ORCID 0000-0002-8494-6252
Paola MinghettiDepartment of Pharmaceutical Science, Università degli Studi di Milano, Milan, Italy.
Pierluigi NavarraDepartment of Healthcare Surveillance and Bioethics, Section of Pharmacology, Catholic University Medical School, Fondazione Policlinico Universitario A. Gemelli-IRCCS, Rome, Italy.
Agostino Gemelli University Polyclinic · ITAOL (United States) · USUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A high percentage of patients with chronic kidney disease have hypovitaminosis D, which is a driver of secondary hyperparathyroidism and an important factor in chronic kidney disease-mineral and bone disorder. Vitamin D deficiency (serum total 25-OH vitamin D levels < 30 ng/mL) occurs early in the course of chronic kidney disease and treatment guidelines recommend early intervention to restore 25-OH vitamin D levels as a first step to prevent/delay the onset/progression of secondary hyperparathyroidism. The vitamin D forms administered to replace 25-OH vitamin D include cholecalciferol, ergocalciferol, and immediate- or extended-release formulations of calcifediol. Most patients with intermediate-stage chronic kidney disease will develop secondary hyperparathyroidism before dialysis is required. Control of parathyroid hormone levels becomes a major focus of therapy in these patients. This article focuses on the position of extended-release calcifediol in the treatment of patients with stage 3-4 chronic kidney disease and secondary hyperparathyroidism with hypovitaminosis D. Several characteristics of extended-release calcifediol support its use in the intermediate stages of chronic kidney disease. The pharmacokinetics of extended-release calcifediol make it effective for replenishing 25-OH vitamin D levels, with minimal impact on vitamin D catabolism from fibroblast-growth factor-23 and CYP24A1 upregulation. Extended-release calcifediol increases circulating 25-OH vitamin D levels in a dose-dependent manner and lowers parathyroid hormone levels by a clinically relevant extent, comparable to what can be achieved by administering active vitamin D analogues, though with a lower risk of hypercalcaemia and hyperphosphataemia. Active vitamin D analogues are reserved for patients undergoing dialysis or pre-dialysis patients with severe progressive secondary hyperparathyroidism.

Indexed as

Hyperparathyroidism, SecondaryRenal Insufficiency, ChronicVitamin D DeficiencyCalcifediolHumansParathyroid HormoneVitamin DVitaminsCalcifediolParathyroid HormoneVitamin DVitaminsCalcifediolChronic kidney diseaseParathyroid hormoneSecondary hyperparathyroidismVitamin DVitamin D insufficiency

Identifiers

PMID34626363
PMCPMC8995284
OpenAlexW3201826530

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.