Evidence map›Paper›PMID 30141180›Full record

ArticlePediatric nephrology (Berlin, Germany)2019

An open-label, single-dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of cinacalcet in pediatric subjects aged 28 days to < 6 years with chronic kidney disease receiving dialysis.

Winnie Y Sohn, Anthony A Portale, Isidro B Salusky, Hao Zhang, Lucy L Yan, Bella Ertik, Shahnaz Shahinfar, Edward Lee, Bastian Dehmel, Bradley A Warady

Erratum issued Registry-linked trialAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Pediatric nephrology (Berlin, Germany), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01290029 (An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Cinacalcet HCl in Pediatric Subjects Aged 28 Days to Less Than 6 Years With Chronic Kidney Disease Receiving Dialysis), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
–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.

NCT01290029 phase1completednot on this map

An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Cinacalcet HCl in Pediatric Subjects Aged 28 Days to Less Than 6 Years With Chronic Kidney Disease Receiving Dialysis

TypeinterventionalSponsorAmgenRan2011 to 2015Enrolled14ConditionsChronic Kidney Disease, Hyperparathyroidism, Secondary, Secondary HyperparathyroidismArmsCinacalcet
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Review
  3. Article
  4. Article
  5. Review
  6. Article
  7. Treatment of hyperphosphatemia: the dangers of high PTH levels.Pediatric nephrology (Berlin, Germany) · 2020
    Review
  8. Article
  9. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Winnie Y SohnAmgen, Inc., One Amgen Center Dr. M/S 38-4-A, Thousand Oaks, CA, 91320, USA. wkim@amgen.com.ORCID 0000-0002-9469-1345
Anthony A PortaleUCSF Benioff Children's Hospital, San Francisco, CA, USA.
Isidro B SaluskyDavid Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
Hao ZhangAmgen, Inc., One Amgen Center Dr. M/S 38-4-A, Thousand Oaks, CA, 91320, USA.
Lucy L YanAmgen, Inc., One Amgen Center Dr. M/S 38-4-A, Thousand Oaks, CA, 91320, USA.
Bella ErtikAmgen, Inc., One Amgen Center Dr. M/S 38-4-A, Thousand Oaks, CA, 91320, USA.
Shahnaz ShahinfarS. Shahinfar Consulting and Childrens Hospital of Philadelphia, Philadelphia, PA, USA.
Edward LeeAmgen, Inc., One Amgen Center Dr. M/S 38-4-A, Thousand Oaks, CA, 91320, USA.
Bastian DehmelAmgen, Inc., One Amgen Center Dr. M/S 38-4-A, Thousand Oaks, CA, 91320, USA.
Bradley A WaradyChildren's Mercy Hospital, Kansas City, MO, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCalcimimetics, shown to control biochemical parameters of secondary hyperparathyroidism (SHPT), have well-established safety and pharmacokinetic profiles in adult end-stage renal disease subjects treated with dialysis; however, such studies are limited in pediatric subjects.

methodsIn this study, the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of cinacalcet were evaluated in children with chronic kidney disease (CKD) and SHPT receiving dialysis. Twelve subjects received a single dose of cinacalcet (0.25 mg/kg) orally or by nasogastric or gastric tube. Subjects were randomized to one of two parathyroid hormone (PTH) and serum calcium sampling sequences: [(1) 2, 8, 48 h; or (2) 2, 12, 48 h] and assessed for 72 h after dosing.

resultsMedian plasma cinacalcet t

conclusionsIn conclusion, a single 0.25 mg/kg dose of cinacalcet was evaluated to be a safe starting dose in these children aged < 6 years.

Indexed as

Administration, OralChildChild, PreschoolCinacalcetDose-Response Relationship, DrugFemaleHalf-LifeHumansHyperparathyroidism, SecondaryInfantInfant, NewbornMaleParathyroid HormoneRenal DialysisRenal Insufficiency, ChronicCinacalcetParathyroid HormoneCalcimimeticsChronic kidney diseaseCinacalcetParathyroid hormonePediatric dialysis patientsSecondary hyperparathyroidism

Identifiers

PMID30141180
PMCPMC6244811

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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.