Evidence map›Paper›PMID 28836058›Full record

ArticleClinical and experimental nephrology2018

Long-term effects of etelcalcetide as intravenous calcimimetic therapy in hemodialysis patients with secondary hyperparathyroidism.

Takashi Shigematsu, Masafumi Fukagawa, Keitaro Yokoyama, Takashi Akiba, Akifumi Fujii, Motoi Odani, Tadao Akizawa, ONO-5163 Study Group

Abstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in Clinical and experimental nephrology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing 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

14 citing papers in PubMed.

  1. Trial
  2. One-year safety and efficacy of intravenous etelcalcetide in patients on hemodialysis with secondary hyperparathyroidism.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2020
    Trial
  3. Bone turnover markers in the management of CKD-associated osteoporosis-a European consensus.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2026
    Review
  4. Upacicalcet: A Novel Intravenous Calcimimetic Agent for Patients Undergoing Hemodialysis With Secondary Hyperparathyroidism.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
    Review
  5. Review
  6. Article
  7. Observational
  8. Review
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Managing hyperparathyroidism in hemodialysis: role of etelcalcetide.International journal of nephrology and renovascular disease · 2018
    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

8 authors.

Takashi ShigematsuDepartment of Nephrology, Wakayama Medical University, 811-1 Kimiidera, Wakayama, 641-8509, Japan. taki@wakayama-med.ac.jp.
Masafumi FukagawaDivision of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine, Isehara, Japan.
Keitaro YokoyamaDivision of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.
Takashi AkibaSekikawa Hospital, Tokyo, Japan.
Akifumi FujiiClinical Development Planning, Ono Pharmaceutical Co. Ltd, Osaka, Japan.
Motoi OdaniData Science, Ono Pharmaceutical Co. Ltd, Osaka, Japan.
Tadao AkizawaDivision of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.
ONO-5163 Study Group

Funding

ONO Pharmaceutical Co. Ltd. JapicCTI-142665
6 · The paper itself

Abstract

backgroundSecondary hyperparathyroidism (SHPT) is a serious major complication in hemodialysis patients with chronic kidney disease. Long-term maintenance of serum phosphate, calcium, and parathyroid hormone (PTH) levels in appropriate ranges in these patients is a major challenge. We investigated the efficacy and safety of long-term treatment with etelcalcetide, a novel intravenous calcimimetic, in Japanese SHPT patients on long-term hemodialysis.

methodsThis study was a multicenter open-label study. A total of 191 hemodialysis patients with serum intact PTH (iPTH) > 240 pg/mL were enrolled. Etelcalcetide was administered thrice weekly for 52 weeks, with an initial dose of 5 mg and flexibility to adjust the dose between 2.5 and 15 mg and to adjust the dosing of concomitant medications for SHPT. The efficacy endpoint was the proportion of patients with serum iPTH decreased to the target range (60-240 pg/mL).

resultsSerum iPTH levels decreased immediately after etelcalcetide was started. At the end of the study, 87.5% (95% confidence interval 81.4-92.2; 140/160 patients) of patients achieved target serum iPTH levels, with control of serum calcium and phosphate levels. Adverse events, mostly mild to moderate, were reported by 96.8% of patients and led to study discontinuation in 7.4% of patients. Nausea, vomiting, and symptomatic hypocalcemia were found in 4.7, 9.5, and 1.1%, with 0.5, 1.1, and 1.1% considered treatment-related.

conclusionsEtelcalcetide effectively maintained serum iPTH, calcium, and phosphate levels in appropriate ranges with concomitant medications for SHPT for 52 weeks in Japanese hemodialysis patients, and was safe and well tolerated. REGISTRATION NUMBER: JapicCTI-142665.

Indexed as

Administration, IntravenousAgedBiomarkersCalcimimetic AgentsCalciumDrug Administration ScheduleFemaleHumansHyperparathyroidism, SecondaryJapanMaleMiddle AgedParathyroid HormonePeptidesPhosphatesRenal DialysisBiomarkersCalcimimetic AgentsCalciumetelcalcetide hydrochlorideParathyroid HormonePeptidesPhosphatesPTH protein, humanCalcimimeticsEtelcalcetideFibroblast growth factor 23HemodialysisLong-term therapySecondary hyperparathyroidism

Identifiers

What OpenQuestion holds

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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.