Evidence map›Paper›PMID 22639045›Full record

Trial reportPediatric nephrology (Berlin, Germany)2012

An open-label study to evaluate a single-dose of cinacalcet in pediatric dialysis subjects.

Desmond Padhi, Craig B Langman, Sahar Fathallah-Shaykh, Bradley A Warady, Isidro B Salusky, Edward Lee, Christine Wang, Edward Posvar

Open access · hybridAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Pediatric nephrology (Berlin, Germany), 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
0.9field-weighted citation impact, top 27% 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, 21 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Review
  5. Article
  6. Article
  7. Review
  8. Cinacalcet administration by gastrostomy tube in a child receiving peritoneal dialysis.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2014
    Article
  9. Parathyroid conditions in childhood.Seminars in pediatric surgery · 2014
    Review
  10. Article
  11. Review
  12. Intraperitoneal Calcitriol for Treatment of Severe Hyperparathyroidism in Children with Chronic Kidney Disease: A Therapy Forgotten.Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis
    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

8 authors at 5 institutions in 1 country.

Desmond PadhiEarly Development, Amgen Inc., One Amgen Center Dr., M/S 38-3-A, Thousand Oaks, CA 91320, USA. dpadhi@amgen.com
Craig B Langman
Sahar Fathallah-Shaykh
Bradley A Warady
Isidro B Salusky
Edward Lee
Christine Wang
Edward Posvar
Amgen (United States) · USChildren's Mercy Hospital · USNorthwestern Memorial Hospital · USUniversity of Alabama at Birmingham · USUniversity of California, Los Angeles · US

Funding

MULTIDISCIPLINARY CLINICAL AND TRANSLATIONAL SCIENCE (MCTS) PROGRAM (UL1)UL1RR025741 · NCRR · NORTHWESTERN UNIVERSITY AT CHICAGO · PI GREENLAND, PHILIP · 2008 to 2011
$24.7M
Multidisciplinary Clinical and Translational Science (MCTS) Program (UL1)UL1TR000150 · NCATS · NORTHWESTERN UNIVERSITY AT CHICAGO · PI LLOYD-JONES, DONALD M · 2012 to 2013
$10.1M
NCATS NIH HHS UL1 TR000150NCRR NIH HHS UL1 RR025741
6 · The paper itself

Abstract

backgroundThere is limited knowledge of the effectiveness and safety profile of cinacalcet in pediatric patients with secondary hyperparathyroidism (sHPT) treated with dialysis.

methodsThis was an open-label, single-dose study conducted on 12 pediatric subjects with chronic kidney disease treated with dialysis. Subjects were stratified by four age cohorts and given a single 15-mg oral dose of cinacalcet. Multiple blood samples were collected up to 72 h post-dose for the assessment of serum calcium (Ca), serum intact parathyroid hormone (iPTH), and plasma cinacalcet concentrations.

resultsOverall, cinacalcet was well tolerated with no serious adverse events. Mean (standard deviation) percentage change in serum Ca over the first 12 h post-dose was -2.93 % (5.70 %) with a nadir of -4.34 % (6.04 %) at 8 h; Ca values returned to baseline by 48 h post-dose. Mean percentage change in iPTH over the first 12 h post-dose was 57.94 % (71.82 %) with a nadir of -35.65 % (55.82 %) at 2 h. There was an inverse relationship between peak serum Ca concentration and body surface area (BSA) (r (2) = 0.41), although no relationship was found between area under the curve and age or BSA.

conclusionsThese data support future analysis to determine the therapeutic starting dose of cinacalcet for pediatric patients with sHPT on dialysis.

Indexed as

Renal DialysisAdministration, OralAdolescentAge FactorsArea Under CurveBiomarkersBody Surface AreaCalcimimetic AgentsCalciumChildCinacalcetDrug Dosage CalculationsFemaleHumansHyperparathyroidism, SecondaryMaleBiomarkersCalcimimetic AgentsCalciumCinacalcetNaphthalenesParathyroid HormonePTH protein, human

Identifiers

PMID22639045
PMCPMC3422455
OpenAlexW2026590551

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.