Evidence map›Paper›PMID 31317120›Full record

ArticleKidney international reports2019

Etelcalcetide Is Effective at All Levels of Severity of Secondary Hyperparathyroidism in Hemodialysis Patients.

John Cunningham, Geoffrey A Block, Glenn M Chertow, Kerry Cooper, Pieter Evenepoel, Jan Iles, Yan Sun, Pablo Ureña-Torres, David A Bushinsky

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Kidney international reports, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.1field-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.

NCT01785849 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

TypeinterventionalSponsorAmgenRan2013 to 2014Enrolled508ConditionsHyperparathyroidism, SecondaryArmsEtelcalcetide, Placebo
NCT01788046 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

TypeinterventionalSponsorAmgenRan2013 to 2014Enrolled515ConditionsHyperparathyroidism, SecondaryArmsEtelcalcetide, Placebo
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 21 citations in OpenAlex.

  1. Trial
  2. Real world evaluation of etelcalcetide in the treatment of secondary hyperparathyroidism in hemodialysis patients in Argentina.Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy · 2026
    Observational
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
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  10. 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

9 authors at 5 institutions in 2 countries.

John CunninghamThe Royal Free Hospital and UCL Medical School, London, England.
Geoffrey A BlockDenver Nephrology, Denver, Colorado, USA.
Glenn M ChertowStanford University School of Medicine, Stanford, California, USA.
Kerry CooperAmgen Inc., Thousand Oaks, California, USA.
Pieter EvenepoelUniversity Hospitals Leuven, Leuven, Belgium.
Jan IlesAmgen Inc., Thousand Oaks, California, USA.
Yan SunAmgen Inc., Thousand Oaks, California, USA.
Pablo Ureña-TorresClinique du Landy, Service de Néphrologie-Dialyse, Saint Ouen, France.
David A BushinskyUniversity of Rochester School of Medicine, Nephrology Division, Rochester, New York, USA.
Amgen (United States) · USColorado Kidney Care · USStanford University · USUniversity College London · GBUniversity of Rochester · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCalcimimetics improve parameters of secondary hyperparathyroidism (sHPT) but are mostly initiated when patients have severe disease, potentially limiting effectiveness. We evaluated the effects of etelcalcetide on lowering intact parathyroid hormone, calcium, and phosphate at different disease severity levels.

methodsThis analysis examined data from 2 parallel, phase 3, randomized, placebo-controlled, 26-week trials conducted in 1023 adult (≥18 years old) patients with sHPT on maintenance hemodialysis. Etelcalcetide effects by baseline intact parathyroid hormone stratum (<600, 600-1000, and >1000 ng/l) on mean percentage change in intact parathyroid hormone; changes in calcium and phosphate; and achieving serum intact parathyroid hormone ≤300 ng/l, phosphate <1.78 mmol/l, and both combined, were assessed.

resultsEtelcalcetide reduced serum intact parathyroid hormone by a similar percentage across baseline strata. A similar proportion achieved >30% intact parathyroid hormone reduction across strata for the etelcalcetide arms. Parathyroid hormone increased modestly in each placebo-group stratum, most prominently in the lowest stratum. Serum calcium and phosphate concentrations decreased across strata in etelcalcetide-treated patients, with the most pronounced reductions in patients with highest baseline parathyroid hormone. However, the proportion of patients achieving parathyroid hormone, phosphate, and both targets was highest in the lowest baseline parathyroid hormone stratum, where etelcalcetide dose requirements were lowest. Etelcalcetide dose requirement was lowest among patients in the lowest intact parathyroid hormone stratum.

conclusionEtelcalcetide effectively lowered serum intact parathyroid hormone, calcium, and phosphate, irrespective of the severity of secondary hyperparathyroidism. The ability to achieve target goals was greatest, and dose requirement smallest, when etelcalcetide was initiated among patients with the lowest level of disease severity.

Indexed as

calciumchronic kidney diseasehemodialysismineral metabolismparathyroid hormonephosphate

Identifiers

PMID31317120
PMCPMC6611952
OpenAlexW2940328205

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.