Evidence map›Paper›PMID 31015494›Full record

Trial reportScientific reports2019

Long-Term Efficacy and Safety of Evocalcet in Japanese Patients with Secondary Hyperparathyroidism Receiving Hemodialysis.

Keitaro Yokoyama, Ryutaro Shimazaki, Masafumi Fukagawa, Tadao Akizawa, Evocalcet Study Group

Open access · goldAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Scientific reports, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
2.8field-weighted citation impact, top 9% 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

15 citing papers in PubMed, 23 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Review
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Evocalcet: A New Oral Calcimimetic for Dialysis Patients 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 · 2020
    Review
  13. Article
  14. Article
  15. 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

5 authors at 11 institutions in 1 country.

Keitaro YokoyamaDivision of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, 105-8461, Japan. keitaro@jikei.ac.jp.
Ryutaro ShimazakiR&D Division, Kyowa Hakko Kirin Co., Ltd., 1-9-2 Otemachi, Chiyoda-ku, Tokyo, 100-0004, Japan.
Masafumi FukagawaDivision of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine, 143 Shimokasuya, Isehara-shi, Kanagawa, 259-1193, Japan.
Tadao AkizawaDivision of Nephrology, Department of Medicine, Showa University School of Medicine, Namics 301, 4-24-51 Takanawa, Minato-ku, Tokyo, 108-0074, Japan.
Evocalcet Study Group
Daiyukai General Hospital · JPJA Toride Medical Center · JPNagoya Ekisaikai Hospital · JPNational Sagamihara Hospital · JPSeirei Sakura Citizen Hospital · JPTsukuba Memorial Hospital · JPJikei University School of Medicine · JPKyowa Kirin (Japan) · JPShirasagi Hospital · JPShowa University · JPTokai University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Secondary hyperparathyroidism (SHPT) is a common complication of chronic kidney disease (CKD), and as the disease progresses SHPT is associated with systemic consequences, termed CKD-mineral and bone disorder. Currently, cinacalcet is indicated for the treatment of SHPT; however, cinacalcet is associated with upper gastrointestinal adverse events. Evocalcet has been developed to address these issues, but the long-term safety and efficacy of evocalcet need to be evaluated. To more accurately reflect clinical practice, this phase 3, multicenter, open-label study was specifically designed without a cinacalcet washout period, and focused on those patients who switched from cinacalcet to evocalcet. A total of 137 SHPT patients undergoing hemodialysis were enrolled, of whom 113 switched from cinacalcet to evocalcet. The most frequent type of adverse drug reaction was decreased adjusted calcium. The incidence of gastrointestinal-related adverse events did not increase in a dose-dependent manner as the dose of evocalcet was increased. The percentage of patients achieving the target intact parathyroid hormone concentration increased from 40.9% to 72.3% with 52-week treatment. The corrected serum calcium and phosphorus levels remained largely unchanged throughout the study. The long-term safety and efficacy of evocalcet was confirmed using a clinically relevant intra-subject dose-adjustment strategy in SHPT patients undergoing hemodialysis.

Indexed as

Asian PeopleRenal DialysisCalciumDose-Response Relationship, DrugFemaleHumansHyperparathyroidism, SecondaryMaleMiddle AgedNaphthalenesPyrrolidinesTime FactorsTreatment OutcomeVitamin DCalciumevocalcetNaphthalenesPyrrolidinesVitamin D

Identifiers

PMID31015494
PMCPMC6478860
OpenAlexW2941142102

What OpenQuestion holds

Textmetadata
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.