Evidence map›Paper›PMID 30196301›Full record

Trial reportAmerican journal of nephrology2018

Switching from Epoetin Alfa (Epogen®) to Epoetin Alfa-Epbx (RetacritTM) Using a Specified Dosing Algorithm: A Randomized, Non-Inferiority Study in Adults on Hemodialysis.

Ravi Thadhani, Ruffy Guilatco, Jeffrey Hymes, Franklin W Maddux, Ajay Ahuja

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIEquivalence TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in American journal of nephrology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02504294 (The Pieda Study), which is not on this map. Cited by 5 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 3 pooled it
0.8field-weighted citation impact, top 26% 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.

NCT02504294 phase3completednot on this map

The Pieda Study: A Phase 3b Investigation Of Erythropoietin Drugs Using A Specified Dosing Algorithm: A Randomized Open Label Dosing Study In Adult Chronic Kidney Disease Subjects On Hemodialysis

TypeinterventionalSponsorPfizerRan2015 to 2016Enrolled432ConditionsChronic Kidney Disease (CKD)ArmsEpoetin Hospira Arm, Standard of Care Arm, IV Iron
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 3 syntheses or guidelines pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
  5. Review
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

5 authors at 4 institutions in 1 country.

Ravi ThadhaniDepartment of Biomedical Sciences, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Ruffy GuilatcoPfizer Essential Health, Clinical Development and Medical Affairs, Pfizer Inc., Makati City, Philippines.
Jeffrey HymesFresenius Medical Care North America, Waltham, Massachusetts, USA.
Franklin W MadduxFresenius Medical Care North America, Waltham, Massachusetts, USA.
Ajay AhujaPfizer Essential Health, Clinical Development and Medical Affairs, Pfizer Inc., Lake Forest, Illinois, USA.
Cedars-Sinai Medical Center · USFresenius Medical Care North America (United States)Fresenius Medical Care (United States) · USPfizer (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFor patients with anemia undergoing hemodialysis, erythropoiesis-stimulating agents (ESAs) are typically dosed via precise algorithms. Using one such algorithm, we assessed the maintenance of hemoglobin levels in patients switched from epoetin alfa reference product (Epogen®) to epoetin alfa-epbx (RetacritTM; a biosimilar to US-licensed Epogen®/Procrit®).

methodsThis randomized, open-label, non-inferiority study was conducted at Fresenius Medical Care North America (FMCNA) hemodialysis centers. Patients with anemia and chronic kidney disease undergoing maintenance hemodialysis and receiving routine intravenous (IV) Epogen® were randomized 1: 1 to switch to IV RetacritTM or continue standard-of-care (Epogen®) for 24 weeks, using analogous versions of the FMCNA ESA-dosing algorithm. The primary endpoint was the proportion of time patients' hemoglobin was 9-11 g/dL during weeks 17-24.

resultsOf 432 randomized patients, 418 received treatment (RetacritTM, n = 212; standard-of-care, n = 206) and comprised the full analysis set. A similar proportion of patients discontinued from each arm. The proportion of time patients' hemoglobin was within the target range was 61.9% (95% CI 57.5-66.2) in the RetacritTM arm and 63.3% (95% CI 58.7-67.7) in the standard-of-care arm. The difference in proportions between treatment arms was -1.4% (95% CI -7.6 to 4.9), and the lower bound of the confidence interval was within the pre-specified non-inferiority margin of -12.5%. There was no statistically significant difference between arms in the mean change from baseline in the weekly mean ESA dose during weeks 17-24, and no clinically relevant differences in safety outcomes.

conclusionsSwitching to RetacritTM was non-inferior to continuing -Epogen® in maintaining hemoglobin levels in patients receiving hemodialysis, when both ESAs were dosed using a specified algorithm (ClinicalTrials.gov, NCT02504294).

Indexed as

AdultAgedAged, 80 and overAlgorithmsAnemiaBiosimilar PharmaceuticalsDose-Response Relationship, DrugDrug Dosage CalculationsDrug SubstitutionEpoetin AlfaFemaleHematinicsHemoglobinsHumansInjections, IntravenousKidney Failure, ChronicBiosimilar PharmaceuticalsEpoetin AlfaHematinicsHemoglobinsAnemiaBiosimilarChronic kidney diseaseDialysisEpoetin alfaEpoetin alfa-epbxErythropoietinSwitching

Identifiers

PMID30196301
PMCPMC6214608
OpenAlexW2889614501

What OpenQuestion holds

Textmetadata
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.