Evidence map›Paper›PMID 30253403›Full record

Trial reportAmerican journal of nephrology2018

Comparing Therapeutic Efficacy and Safety of Epoetin Beta and Epoetin Alfa in the Treatment of Anemia in End-Stage Renal Disease Hemodialysis Patients.

Jalal Azmandian, Mohammad Reza Abbasi, Vahid Pourfarziani, Amir Ahmad Nasiri, Shahrzad Ossareh, Shahrokh Ezzatzadegan Jahromi, Hooshang Sanadgol, Somayeh Amini, Arshia Shahvaroughi Farahani

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyEquivalence 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 NCT03408639 (A Phase III, Randomized, Two Armed, Parallel, Double Blind), which is not on this 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
1.5field-weighted citation impact, top 17% 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.

NCT03408639 phase3completednot on this map

A Phase III, Randomized, Two Armed, Parallel, Double Blind (Patient and Assessor Blinded), Active Controlled Non Inferiority Clinical Trial to Determine the Non Inferior Therapeutic Efficacy and Safety Between CinnaPoietin® (Beta Erythropoietin) and Eprex® (Epoetin Alpha) on the Treatment of Anemia in ESRD Hemodialysis Patients

TypeinterventionalSponsorCinnagenRan2016 to 2017Enrolled156ConditionsAnemia in End-Stage Renal DiseaseArmsCinnaPoietin®, Eprex®, Nephrovit, Vitamin B12 Injection
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Drug Utilization Evaluation of Erythropoietin at a Referral Teaching Hospital in Iran.Advances in pharmacological and pharmaceutical sciences · 2023
    Article
  3. STAT5 as a Key Protein of Erythropoietin Signalization.International journal of molecular sciences · 2021
    Review
  4. Article
  5. Article
  6. Updates on Novel Erythropoiesis-Stimulating Agents: Clinical and Molecular Approach.Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion · 2020
    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

9 authors at 6 institutions in 1 country.

Jalal AzmandianDepartment of Nephrology, Kerman University of Medical Sciences, Kerman, Iran.
Mohammad Reza AbbasiNephrology Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Vahid PourfarzianiNephrology and Urology Research Center, Baqyiatallah University of Medical Sciences, Tehran, Iran.
Amir Ahmad NasiriImam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Shahrzad OssarehHasheminejad Kidney Center, Iran University of Medical Sciences, Tehran, Iran.
Shahrokh Ezzatzadegan JahromiShiraz Nephro-Urology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
Hooshang SanadgolHasheminejad Kidney Center, Iran University of Medical Sciences, Tehran, Iran.
Somayeh AminiHead of Medical Department, Orchid Pharmed Company, Tehran, Iran.
Arshia Shahvaroughi FarahaniFaculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
Hasheminejad Kidney Center · IRTehran University of Medical Sciences · IRBaqiyatallah University of Medical Sciences · IRImam Hossein Hospital · IRKerman University of Medical Sciences · IRShiraz University of Medical Sciences · IR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAnemia is one of the most prevalent complications in patients with chronic kidney disease, which is believed to be caused by the insufficient synthesis of erythropoietin by the kidney. This phase III study aimed to compare the efficacy and safety of CinnaPoietin® (epoetin beta, CinnaGen) with Eprex® (epoetin alfa, Janssen Cilag) in the treatment of anemia in ESRD hemodialysis patients.

methodsIn this randomized, active-controlled, double-blind, parallel, and non-inferiority trial, patients were randomized to receive either CinnaPoietin® or Eprex® for a 26-week period. The primary endpoints of this study were to assess the mean hemoglobin (Hb) change during the last 4 weeks of treatment from baseline along with the evaluation of the mean weekly epoetin dosage per kilogram of body weight that was necessary to maintain the Hb level within 10-12 g/dL during the last 4 weeks of treatment. As the secondary objective, safety was assessed along with other efficacy endpoints.

resultsA total of 156 patients were included in this clinical trial. There was no statistically significant difference between treatment groups regarding the mean Hb change (p = 0.21). In addition, the mean weekly epoetin dosage per kg of body weight for maintaining the Hb level within 10-12 g/dL showed no statistically significant difference between treatment arms (p = 0.63). Moreover, both products had comparable safety profiles. However, the incidence of Hb levels above 13 g/dL was significantly lower in the CinnaPoietin® group.

conclusionCinnaPoietin® was proved to be non-inferior to Eprex® in the treatment of anemia in ESRD hemodialysis patients. The trial was registered in Clinicaltrials.gov (NCT03408639).

Indexed as

AdultAgedAnemiaEpoetin AlfaErythropoietinFemaleHematinicsHemoglobinsHumansInjections, SubcutaneousKidney Failure, ChronicMaleMiddle AgedProspective StudiesRecombinant ProteinsRenal DialysisEpoetin Alfaepoetin betaErythropoietinHematinicsHemoglobinsRecombinant ProteinsAnemiaCinnaPoietin®End-stage renal diseaseEprex®Hemodialysis

Identifiers

PMID30253403
PMCPMC6381861
OpenAlexW2892400856

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.