Evidence map›Paper›PMID 36972619›Full record

ArticleDrug research2023

Comparative Study of Recombinant Human Erythropoietin (rhEPO) Products on CKD (Chronic Kidney Disease) Patients.

Kuspuji Dwitanto, Nova Angginy, Widodo Sutandar

Open access · hybridAbstract readMulticenter Study
In one paragraph

Article in Drug research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.9field-weighted citation impact, top 24% 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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Review
  2. 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

3 authors at 2 institutions in 2 countries.

Kuspuji DwitantoCempaka Putih Jakarta Islamic Hospital, Jakarta.
Nova AngginyDaewoong Pharmaceutical Co., Ltd. Seoul.
Widodo SutandarDr. Esnawan Antariksa Air Force Hospital, Jakarta.
Daewoong Pharmaceutical (South Korea) · KRIslamic Hospital · JO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis study was conducted to evaluate whether the efficacy and safety profile of recombinant human erythropoietin (rhEPO) manufactured by Daewoong Pharmaceutical Co., Ltd was similar to biological products approved by the drug safety regulatory authority. PATIENTS AND

methodsIt was an open-label, randomized, comparative, parallel, multi-center study in hemodialysis patients with anemia. The reference product at an individualized dose 3 times a week was given in 4-8 weeks of titration period and hemoglobin (Hb) level was controlled to reach the range of 10-12 g/dL. Then, the subjects were randomly administered with reference or test product with the same dose regimen. The primary endpoints were to demonstrate the Hb level change between baseline and evaluation period in both treatment groups, while the secondary endpoints were the mean change in weekly dosage per kg body weight and the instability rate of Hb level during maintenance and evaluation period. The safety was evaluated based on the adverse events incidence.

resultsThere was no statistical difference in the change of Hb between test and reference (0.14 g/dL and 0.75 g/dL respectively, with p>0.05), also for the mean changes of weekly dosage between groups (1091.40 IU and 570.15 IU respectively, with p>0.05). The instability rate of Hb in both test and reference was not statistically significantly different as well (26 and 15% respectively, with p>0.05).

conclusionThis study proves that the efficacy indicated by the change instability of Hb and safety indicated by adverse event incidence of Epodion and the reference product on chronic kidney disease were similar.

Indexed as

AnemiaErythropoietinHematinicsKidney Failure, ChronicRenal Insufficiency, ChronicEpoetin AlfaHemoglobinsHumansRecombinant ProteinsTreatment OutcomeEpoetin AlfaErythropoietinHematinicsHemoglobinsRecombinant Proteins

Identifiers

PMID36972619
PMCPMC10241559
OpenAlexW4360991163

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.