Evidence map›Paper›PMID 33305109›Full record

ArticleKidney international reports2020

A Prospective, Randomized Clinical Trial of Etelcalcetide in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism (the DUET Trial).

Yuya Itano, Sawako Kato, Masato Tsuboi, Hirotake Kasuga, Yoshinari Tsuruta, Fumihiko Sato, Manabu Hishida, Takuji Ishimoto, Tomoki Kosugi, Masahiko Ando and 2 more

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In one paragraph

Article in Kidney international reports, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 22% 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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
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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

12 authors at 3 institutions in 1 country.

Yuya ItanoDepartment of Nephrology, Nagoya University Graduate School of Medicine, Aichi, Japan.
Sawako KatoDepartment of Nephrology, Nagoya University Graduate School of Medicine, Aichi, Japan.
Masato TsuboiKaikoukai Healthcare Group, Aichi, Japan.
Hirotake KasugaKaikoukai Healthcare Group, Aichi, Japan.
Yoshinari TsurutaMeiyo Clinic, Aichi, Japan.
Fumihiko SatoSato Hospital, Aichi, Japan.
Manabu HishidaDepartment of Nephrology, Nagoya University Graduate School of Medicine, Aichi, Japan.
Takuji IshimotoDepartment of Nephrology, Nagoya University Graduate School of Medicine, Aichi, Japan.
Tomoki KosugiDepartment of Nephrology, Nagoya University Graduate School of Medicine, Aichi, Japan.
Masahiko AndoDepartment of Advanced Medicine, Nagoya University Hospital, Aichi, Japan.
Yachiyo KuwatsukaDepartment of Advanced Medicine, Nagoya University Hospital, Aichi, Japan.
Shoichi MaruyamaDepartment of Nephrology, Nagoya University Graduate School of Medicine, Aichi, Japan.
Nagoya University · JPNagoya University Hospital · JPSatou Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe clinical trial on the Development of a treatment strategy for chronic kidney disease‒mineral and bone disorder by a mUltilateral mechanism of ETelcalcetide hydrochloride, or the DUET trial, was designed to determine the efficacy of etelcalcetide, an intravenous calcimimetic, for control of secondary hyperparathyroidism (SHPT).

methodsEligible SHPT maintenance hemodialysis patients (n = 124) were randomized (1:1:1) for inclusion in the DUET trial, a 12-week, multicenter, open-label, parallel-group study (jRCTs041180108), and assigned to either an etelcalcetide + active vitamin D group (group E+D), an etelcalcetide + oral calcium preparation group (group E+Ca), or a control group (group C). The primary endpoint was number of patients with a 50% reduction from baseline of intact parathyroid hormone (iPTH) levels, and iPTH levels ≤ 240 pg/mL at 12 weeks after start of the trial.

resultsThe proportion of patients reaching the primary endpoint (95% confidence interval [CI]) was 90.0% (76.3%-97.2%) in group E+D, 56.8% (39.5%-72.9%) in group E+Ca, and 19.5% (8.8%-34.9%) in group C. Etelcalcetide treatment led to a significant increase in the number of patients achieving the endpoint (odds ratio, 13.4; 95% CI, 5.10-35.3) on logistic regression analysis, with iPTH, corrected serum calcium, and phosphate at baseline as covariates. Significantly more patients achieved the endpoint in group E+D compared with group E+Ca (odds ratio, 6.35; 95% CI, 1.79-22.48). There were fewer hypocalcemic visits in group E+D compared with group E+Ca (

conclusionEtelcalcetide showed good control of iPTH for maintenance hemodialysis patients with SHPT. Active vitamin D was useful in correcting hypocalcemia, but the oral calcium preparation was superior for suppression of hyperphosphatemia.

Indexed as

calcimimeticetelcalcetidehemodialysisrandomized studysecondary hyperthyroidism

Identifiers

PMID33305109
PMCPMC7710846
OpenAlexW3087476063

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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.