Evidence map›Paper›PMID 35763247›Full record

Trial reportClinical pharmacokinetics2022

First-in-Patient Phase I/II Study of Upacicalcet in Japanese Patients with Secondary Hyperparathyroidism Undergoing Hemodialysis: Pharmacokinetic and Pharmacodynamic Properties.

Junichiro James Kazama, Fumihiko Koiwa, Keitaro Yokoyama, Masafumi Fukagawa, Kenji Asano, Daisuke Honda, Tadao Akizawa

Open access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical pharmacokinetics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 18% 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. 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
  4. Review
  5. Article
  6. 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

7 authors at 6 institutions in 1 country.

Junichiro James KazamaDepartment of Nephrology and Hypertension, Fukushima Medical University, Fukushima, Japan.
Fumihiko KoiwaDivision of Nephrology, Department of Internal Medicine, Showa University Fujigaoka Hospital, Yokohama, Japan.
Keitaro YokoyamaDepartment of Health Science, The Graduate School, The Jikei University School of Medicine, Tokyo, Japan.
Masafumi FukagawaDivision of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine, Isehara, Japan.
Kenji AsanoClinical Development Department, Sanwa Kagaku Kenkyusho Co., Ltd., Nagoya, Japan.
Daisuke HondaProject Management Department, Sanwa Kagaku Kenkyusho Co., Ltd., Nagoya, Japan. d_honda@skk-net.com.ORCID 0000-0001-5624-7553
Tadao AkizawaDivision of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.
Riso Kagaku (Japan) · JPFukushima Medical University · JPJikei University School of Medicine · JPShowa University · JPShowa University Fujigaoka Hospital · JPTokai University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveUpacicalcet is a new renally excreted and injectable calcimimetic agent. We evaluated the pharmacokinetics, pharmacodynamics, safety, and tolerability of single and multiple intravenous administration of upacicalcet in patients with secondary hyperparathyroidism undergoing hemodialysis.

methodsThis study was a multicenter, randomized, placebo-controlled, double-blinded, dose-escalation study consisting of a single-dose study and a multiple-dose study. The single-dose study consisted of seven dose steps from 0.025 to 0.8 mg. For each step, six patients were randomly assigned 2:1 to receive upacicalcet or a placebo. The multiple-dose study occurred over 3 weeks in three-dose steps from 0.05 to 0.2 mg. For each step, 12 patients were randomly assigned 3:1 to receive upacicalcet or a placebo.

resultsThe plasma concentration of upacicalcet increased in a dose-dependent manner and was maintained for the next dialysis. Upacicalcet was approximately 80% removed by a single dialysis and did not increase in the plasma concentration with repeated administration. Serum intact parathyroid hormone and corrected calcium (Ca

conclusionsUpacicalcet for patients with secondary hyperparathyroidism undergoing hemodialysis could be a calcimimetic agent that acts in a dose-dependent manner and persistently until the next dialysis session. No safety or tolerability issues specific to upacicalcet were found.

Indexed as

Hyperparathyroidism, SecondaryCalcimimetic AgentsDouble-Blind MethodHumansJapanParathyroid HormoneRenal DialysisCalcimimetic AgentsParathyroid Hormone

Identifiers

PMID35763247
PMCPMC9439990
OpenAlexW4283639671

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.