Evidence map›Paper›PMID 39191216›Full record

Trial reportAmerican journal of nephrology2026

Sustained Reduction of Elevated Intact Parathyroid Hormone Concentrations with Extended-Release Calcifediol Slows Chronic Kidney Disease Progression in Secondary Hyperparathyroidism Patients.

Charles W Bishop, Akhtar Ashfaq, Stephen A Strugnell, John Choe, Nilay Patel, Keith C Norris, Stuart M Sprague

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in American journal of nephrology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
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

7 citing papers in PubMed.

  1. Trial
  2. Article
  3. Systemic versus local regulation of vitamin D.Current opinion in nephrology and hypertension · 2026
    Review
  4. Article
  5. Review
  6. Article
  7. Vitamin D: are all compounds equal?Clinical kidney journal · 2025
    Article
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

7 authors.

Charles W BishopOPKO Health, Miami, Florida, USA.
Akhtar AshfaqOPKO Health, Miami, Florida, USA.
Stephen A StrugnellOPKO Health, Miami, Florida, USA, sstrugnell@opko.com.
John ChoeOPKO Health, Miami, Florida, USA.
Nilay PatelOPKO Health, Miami, Florida, USA.
Keith C NorrisDavid Geffen School of Medicine, UCLA, Los Angeles, California, USA.
Stuart M SpragueNorthShore University Health System-University of Chicago, Pritzker School of Medicine, Evanston, Illinois, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionChronic kidney disease (CKD) drives onerous human and healthcare costs, underscoring an urgent need to avert disease progression. Secondary hyperparathyroidism (SHPT) develops as CKD advances, and persistently elevated parathyroid hormone (PTH) may be nephrotoxic and associated with earlier dialysis onset. This study examines, for the first time, the hypothesis that sustained reduction of elevated intact PTH (iPTH) with extended-release calcifediol (ERC) reduces the nephrotoxic impact of SHPT and forestalls renal decline.

methodsChanges in estimated glomerular filtration rate (eGFR) were analyzed post hoc in 126 adults with SHPT, stage 3-4 CKD, and low serum 25-hydroxyvitamin D (25D) treated for 1 year with ERC in pivotal trials. ERC was administered at 30 μg/day increasing, as needed, to 60 μg/day to achieve ≥30% reductions in iPTH. Calcium, phosphorus, 25D, 1,25-dihydroxyvitamin D (1,25D), iPTH, eGFR, fibroblast growth factor-23 (FGF23), bone turnover markers (BTMs), and urine albumin-to-creatinine ratio (uACR) were measured at baseline and regular intervals. Participants were categorized by achievement (or not) of sustained ≥30% iPTH reductions over the last 2 quarters of treatment to evaluate differences in eGFR decline.

resultsFor all participants, 25D increased 58.5 ± 2.3 (SE) ng/mL (p < 0.001) by the end of treatment (EOT), 1,25D increased 10.1 ± 1.8 pg/mL (p < 0.001), iPTH decreased from 143.8 ± 5.8 pg/mL to 108.8 ± 7.2 (p < 0.001), BTMs improved (p < 0.01), and eGFR declined 2.2 ± 0.5 mL/min/1.73 m2 (p < 0.001). The rate of eGFR decline was >5-fold higher (p = 0.014) in participants who did not achieve sustained iPTH reductions of ≥30% (3.2 ± 0.7; 12.7 ± 2.2%) than in those who did (0.6 ± 0.8; 2.9 ± 2.4%). It was highest in the 30 participants who did not exhibit an iPTH lowering response in both of the last 2 quarters of treatment (5.4 ± 0.9; 20.9 ± 3.4%). Duration of iPTH reduction had no impact on safety parameters. Degree of iPTH reduction at EOT was also associated with slower CKD progression.

conclusionSustained reduction of elevated iPTH with ERC treatment was associated with slower rates of eGFR decline in patients with SHPT and stage 3-4 CKD without raising safety concerns. A prospective trial is warranted to confirm this finding.

Indexed as

CalcifediolHyperparathyroidism, SecondaryParathyroid HormoneRenal Insufficiency, ChronicAgedCalciumDelayed-Action PreparationsDisease ProgressionFemaleFibroblast Growth Factor-23Fibroblast Growth FactorsGlomerular Filtration RateHumansMaleMiddle AgedPhosphorus25-hydroxyvitamin DCalcifediolCalciumDelayed-Action PreparationsFGF23 protein, humanFibroblast Growth Factor-23Fibroblast Growth FactorsParathyroid HormonePhosphorusVitamin DChronic kidney diseaseExtended-release calcifediolParathyroid hormoneProgressionSecondary hyperparathyroidism

Identifiers

PMID39191216
PMCPMC13384448

What OpenQuestion holds

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LicenceCC BY-NC
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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.