Evidence map›Paper›PMID 25873267›Full record

Trial reportClinical journal of the American Society of Nephrology : CJASN2015

Effect of Cinacalcet and Vitamin D Analogs on Fibroblast Growth Factor-23 during the Treatment of Secondary Hyperparathyroidism.

Stuart M Sprague, James B Wetmore, Konstantin Gurevich, Gerald Da Roza, John Buerkert, Maureen Reiner, William Goodman, Kerry Cooper

Open access · bronzeAbstract readClinical Trial, Phase IVComparative StudyMulticenter Study
In one paragraph

Trial report in Clinical journal of the American Society of Nephrology : CJASN, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 3 pooled it
5.5field-weighted citation impact, top 4% 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

33 citing papers in PubMed, 3 syntheses or guidelines pooled it, 76 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Trial
  5. Trial
  6. Review
  7. Vitamin D-Parathyroid Hormone-Fibroblast Growth Factor 23 Axis and Cardiac Remodeling.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2025
    Review
  8. Article
  9. Article
  10. Review
  11. Mineral Bone Disorders in Kidney Disease Patients: The Ever-Current Topic.International journal of molecular sciences · 2022
    Review
  12. Article
  13. Phosphate and fibroblast growth factor 23 in diabetes.Clinical science (London, England : 1979) · 2021
    Review
  14. Review
  15. Article
  16. Review
  17. Review
  18. Article
  19. Article
  20. 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

8 authors at 4 institutions in 2 countries.

Stuart M SpragueDivision of Nephrology and Hypertension, NorthShore University HealthSystem, Evanston, Illinois; ssprague@northshore.org.
James B WetmoreDivision of Nephrology, Hennepin County Medical Center, Minneapolis, Minnesota;
Konstantin GurevichFresenius Medical Care, St. Petersburg, Russia;
Gerald Da RozaDivision of Nephrology, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada;
John BuerkertColumbia Nephrology Associates, Columbia, South Carolina; and.
Maureen ReinerClinical Research, Amgen Inc., Thousand Oaks, California.
William GoodmanClinical Research, Amgen Inc., Thousand Oaks, California.
Kerry CooperClinical Research, Amgen Inc., Thousand Oaks, California.
Amgen (United States) · USHennepin County Medical Center · USNorthShore University HealthSystem · USUniversity of British Columbia · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesCinacalcet and vitamin D are often combined to treat secondary hyperparathyroidism (SHPT) in patients on dialysis. Independent effects on fibroblast growth factor-23 (FGF-23) concentrations in patients on hemodialysis administered cinacalcet or vitamin D analogs as monotherapies during treatment of SHPT are evaluated. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: A multicenter, randomized, open-label study to compare the efficacy of cinacalcet versus traditional vitamin D therapy for management of secondary hyperparathyroidism among subjects undergoing hemodialysis (PARADIGM) was a prospective, phase 4, multicenter, randomized, open-label study conducted globally. Participants (n=312) were randomized 1:1 to cinacalcet (n=155) or vitamin D analog (n=157) for 52 weeks. Levels of FGF-23 were measured at baseline and weeks 20 and 52. The absolute and percentage changes from baseline in plasma FGF-23, parathyroid hormone (PTH), calcium (Ca), phosphorus (P), and calcium-phosphorus product (Ca×P) were assessed. Correlations and logistic regression were used to explore relationships between changes in FGF-23 and changes in PTH, Ca, P, and Ca×P from baseline to week 52 by treatment arm.

resultsMedian (quartiles 1, 3) decrease in FGF-23 concentrations was observed in the cinacalcet arm (-40%; -63%, 16%) compared with median increase in the vitamin D analog arm (47%; 0%, 132%) at week 52 (P<0.001). Changes in FGF-23 in both arms were unrelated to changes in PTH (cinacalcet: r=0.17, P=0.11; vitamin D analog: r=-0.04, P=0.70). Changes in FGF-23 in the vitamin D analog but not the cinacalcet arm were correlated with changes in Ca (cinacalcet: r=0.11, P=0.30; vitamin D analog: r=0.32, P<0.01) and P (cinacalcet: r=0.19, P=0.07; vitamin D analog: r=0.49, P<0.001). Changes in FGF-23 were correlated with changes in Ca×P in both arms (cinacalcet: r=0.26, P=0.01; vitamin D analog: r=0.57, P<0.001). Independent of treatment arm, participants with reductions in P or Ca×P were significantly more likely to show reductions in FGF-23.

conclusionsDuring treatment of SHPT, cinacalcet use was associated with a decrease in FGF-23 concentrations, whereas vitamin D analogs were associated with an increase. The divergent effects of these treatments on FGF-23 seem to be independent of modification of PTH. It is possible that effects of cinacalcet and vitamin D analogs on FGF-23 may be mediated indirectly by other effects on bone and mineral metabolism.

Indexed as

Renal DialysisAgedAustraliaBiomarkersCalcimimetic AgentsCalciumCanadaChi-Square DistributionCinacalcetFemaleFibroblast Growth Factor-23Fibroblast Growth FactorsHumansHyperparathyroidism, SecondaryKidney Failure, ChronicLogistic ModelsBiomarkersCalcimimetic AgentsCalciumCinacalcetFGF23 protein, humanFibroblast Growth Factor-23Fibroblast Growth FactorsParathyroid HormonePhosphorusPTH protein, humanVitamin Dclinical nephrologydialysisESRDhyperparathyroidism

Identifiers

PMID25873267
PMCPMC4455198
OpenAlexW2145901046

What OpenQuestion holds

Textmetadata
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.