Evidence map›Paper›PMID 22387567›Full record

Trial reportNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2012

Paricalcitol versus cinacalcet plus low-dose vitamin D therapy for the treatment of secondary hyperparathyroidism in patients receiving haemodialysis: results of the IMPACT SHPT study.

Markus Ketteler, Kevin J Martin, Myles Wolf, Michael Amdahl, Mario Cozzolino, David Goldsmith, Amit Sharma, Steven Marx, Samina Khan

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00977080 (The IMPACT SHPT Study), which is not on this map. Cited by 37 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 6 pooled it
7.5field-weighted citation impact, top 2% 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.

NCT00977080 phase4completednot on this map

The IMPACT SHPT Study: Study to Evaluate the Improved Management of iPTH With Paricalcitol-centered Therapy vs. Cinacalcet Therapy With Low-dose Vitamin D in Hemodialysis Patients With Secondary Hyperparathyroidism

TypeinterventionalSponsorAbbottRan2009 to 2011Enrolled272ConditionsChronic Kidney Disease, Secondary Hyperparathyroidism, HemodialysisArmsParicalcitol, Cinacalcet
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 6 syntheses or guidelines pooled it, 99 citations in OpenAlex.

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  14. Mineral Bone Disorders in Kidney Disease Patients: The Ever-Current Topic.International journal of molecular sciences · 2022
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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

9 authors at 7 institutions in 4 countries.

Markus KettelerDivision of Nephrology, Klinikum Coburg, Coburg, Germany. markus.ketteler@klinikum-coburg.de
Kevin J Martin
Myles Wolf
Michael Amdahl
Mario Cozzolino
David Goldsmith
Amit Sharma
Steven Marx
Samina Khan
Abbott Fund · USGuy's Hospital · GBKlinikum Coburg · DEOspedale San Paolo · ITRenal Research Institute · USSaint Louis University · USUniversity of Miami · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOptimal treatment for secondary hyperparathyroidism (SHPT) has not been defined. The IMPACT SHPT (ClinicalTrials.gov identifier: NCT00977080) study assessed whether dose-titrated paricalcitol plus supplemental cinacalcet only for hypercalcaemia is superior to cinacalcet plus low-dose vitamin D in controlling intact parathyroid hormone (iPTH) levels in patients with SHPT on haemodialysis.

methodsIn this 28-week, multicentre, open-label Phase 4 study, participants were randomly selected to receive paricalcitol or cinacalcet plus low-dose vitamin D. Randomization and analyses were stratified by mode of paricalcitol administration [intravenous (IV) or oral]. The primary efficacy end point was the proportion of subjects who achieved a mean iPTH value of 150-300 pg/mL during Weeks 21-28.

resultsOf 272 subjects randomized, 268 received one or more dose of study drug; 101 in the IV and 110 in the oral stratum with two or more values during Weeks 21-28 were included in the primary analysis. In the IV stratum, 57.7% of subjects in the paricalcitol versus 32.7% in the cinacalcet group (P = 0.016) achieved the primary end point. In the oral stratum, the corresponding proportions of subjects were 54.4% for paricalcitol and 43.4% for cinacalcet (P = 0.260). Cochran-Mantel-Haenszel analysis, controlling for stratum, revealed overall superiority of paricalcitol (56.0%) over cinacalcet (38.2%; P = 0.010) in achieving iPTH 150-300 pg/mL during Weeks 21-28. Hypercalcaemia occurred in 4 (7.7%) and 0 (0%) of paricalcitol-treated subjects in the IV and oral strata, respectively. Hypocalcaemia occurred in 46.9% and 54.7% of cinacalcet-treated subjects in the IV and oral strata, respectively.

conclusionParicalcitol versus cinacalcet plus low-dose vitamin D provided superior control of iPTH, with low incidence of hypercalcaemia.

Indexed as

Renal DialysisAdministration, IntravenousAdministration, OralAgedBone DensityBone Density Conservation AgentsCalciumCinacalcetDrug Therapy, CombinationErgocalciferolsFemaleHumansHypercalcemiaHyperparathyroidism, SecondaryMaleMiddle AgedBone Density Conservation AgentsCalciumCinacalcetErgocalciferolsNaphthalenesParathyroid HormoneparicalcitolReceptors, CalcitriolVitamin D

Identifiers

PMID22387567
PMCPMC3408938
OpenAlexW2136486000

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.