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NCT05373303
The Clinical Study for Evaluating The Safety And Efficacy Of Epodion®
NA trial testing Recombinant Human Erythropoietin Alpha in Chronic Kidney Disease (CKD) in 82 participants. Completed in 28 January 2022.
15 May 2021
Quick facts
| Lead sponsor | PT. Daewoong Infion |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 82 |
| Start date | 7 November 2019 |
| Primary completion | 15 May 2021 |
| Estimated completion | 28 January 2022 |
| Sites | 1 location across Indonesia |
Drugs / interventions tested
- Recombinant Human Erythropoietin Alpha — full drug profile →
- Recombinant Human Erythropoietin Alpha — full drug profile →
Conditions studied
- Chronic Kidney Disease (CKD) — all drugs for Chronic Kidney Disease (CKD) →
Sponsor
PT. Daewoong Infion
Who can join
Adults 18 to 74, any sex, with Chronic Kidney Disease (CKD). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05373303
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other PT. Daewoong Infion trials
Trials by the same sponsor.
- NCT05422755 — The Clinical Study to Evaluate Immunogenicity of Epodion® in Anemia Associated With CKD Patients · completed
- NCT05335720 — Efficacy and Safety Evaluation of EASYEF® in Acute Wound (Split-thickness Skin Graft Donor Site) · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05373303 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by PT. Daewoong Infion
- Last refreshed: 14 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05373303.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing