Evidence map›Paper›PMID 36368937›Full record

ArticleBMC nephrology2022

Real-world assessment: effectiveness and safety of extended-release calcifediol and other vitamin D therapies for secondary hyperparathyroidism in CKD patients.

Michael J Germain, Subir K Paul, George Fadda, Varshasb Broumand, Andy Nguyen, November H McGarvey, Matthew D Gitlin, Charles W Bishop, Philipp Csomor, Stephen Strugnell and 1 more

Open access · goldAbstract read
In one paragraph

Article in BMC nephrology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.9field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. The role of nutritional vitamin D in chronic kidney disease-mineral and bone disorder in children and adults with chronic kidney disease, on dialysis, and after kidney transplantation-a European consensus statement.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2025
    Article
  5. Review
  6. Review
  7. Review
  8. 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

11 authors at 5 institutions in 2 countries.

Michael J GermainRenal Transplant Associates of New England, Springfield, MA, USA.
Subir K PaulShoals Kidney and Hypertension Center, Florence, AL, USA.
George FaddaCalifornia Institute of Renal Research, San Diego, CA, USA.
Varshasb BroumandSouth Texas Renal Care Group, San Antonio, TX, USA.
Andy NguyenBluePath Solutions, Los Angeles, CA, USA.
November H McGarveyBluePath Solutions, Los Angeles, CA, USA.
Matthew D GitlinBluePath Solutions, Los Angeles, CA, USA.
Charles W BishopOPKO Health, Inc, 4400 Biscayne Blvd, Miami, FL, 33137, USA.
Philipp CsomorCSL-Vifor Pharma, Glattbrugg, Switzerland.
Stephen StrugnellOPKO Health, Inc, 4400 Biscayne Blvd, Miami, FL, 33137, USA.
Akhtar AshfaqOPKO Health, Inc, 4400 Biscayne Blvd, Miami, FL, 33137, USA. aashfaq@opko.com.
OPKO Health (United States) · USHypertension Institute · USRenal Associates P. A. · USRenal Research Institute · USVifor Pharma (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionExtended-release calcifediol (ERC), active vitamin D hormones and analogs (AVD) and nutritional vitamin D (NVD) are commonly used therapies for treating secondary hyperparathyroidism (SHPT) in adults with stage 3-4 chronic kidney disease (CKD) and vitamin D insufficiency (VDI). Their effectiveness for increasing serum total 25-hydroxyvitamin D (25D) and reducing elevated plasma parathyroid hormone (PTH), the latter of which is associated with increased morbidity and mortality, has varied across controlled clinical trials. This study aimed to assess real-world experience of ERC and other vitamin D therapies in reducing PTH and increasing 25D.

methodsMedical records of 376 adult patients with stage 3-4 CKD and a history of SHPT and VDI from 15 United States (US) nephrology clinics were reviewed for up to 1 year pre- and post-ERC, NVD or AVD initiation. Key study variables included patient demographics, concomitant usage of medications and laboratory data. The mean age of the study population was 69.5 years, with gender and racial distributions representative of the US CKD population. Enrolled patients were grouped by treatment into three cohorts: ERC (n = 174), AVD (n = 55) and NVD (n = 147), and mean baseline levels were similar for serum 25D (18.8-23.5 ng/mL), calcium (Ca: 9.1-9.3 mg/dL), phosphorus (P: 3.7-3.8 mg/dL) and estimated glomerular filtration rate (eGFR: 30.3-35.7 mL/min/1.73m

resultsSerum 25D rose in all cohorts (p < 0.001) during treatment. ERC yielded the highest increase (p < 0.001) of 23.7 ± 1.6 ng/mL versus 9.7 ± 1.5 and 5.5 ± 1.3 ng/mL for NVD and AVD, respectively. PTH declined with ERC treatment by 34.1 ± 6.6 pg/mL (p < 0.001) but remained unchanged in the other two cohorts. Serum Ca increased 0.2 ± 0.1 pg/mL (p < 0.001) with AVD but remained otherwise stable. Serum alkaline phosphatase remained unchanged.

conclusionsReal-world clinical effectiveness and safety varied across the therapies under investigation, but only ERC effectively raised mean 25D (to well above 30 ng/mL) and reduced mean PTH levels without causing hypercalcemia.

Indexed as

Hyperparathyroidism, SecondaryRenal Insufficiency, ChronicAdultAgedCalcifediolCalciumHumansParathyroid HormoneVitamin DVitaminsCalcifediolCalciumParathyroid HormoneVitamin DVitaminsExtended-release calcifediolReal-worldSecondary hyperparathyroidismVitamin D insufficiencyVitamin D therapy

Identifiers

PMID36368937
PMCPMC9650892
OpenAlexW4308915294

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.