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NCT05768997
High Dose IV Iron Plus ESA in Chemotherapy-induced Anemia
Phase 3 trial testing Ferric Derisomaltose Injection in Anemia in 312 participants. Status unknown.
31 December 2025
Quick facts
| Lead sponsor | Hallym University Medical Center |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 312 |
| Start date | 1 March 2023 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Ferric Derisomaltose Injection — full drug profile →
- Darbepoetin Alfa Injection — full drug profile →
Conditions studied
- Anemia — all drugs for Anemia →
Sponsor
Hallym University Medical Center
Who can join
19 and older, any sex, with Anemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a multicenter, prospective, randomized phase 3 clinical study comparing the efficacy and safety of the combination treatment of ESA and high-dose IV iron (darbepoietin alfa + ferric derisomaltose/iron isomaltoside) with ESA monotherapy (darbepoietin alfa alone) in CIA patients with functional iron deficiency.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Let It Grow: The Role of Growth Factors in Managing Chemotherapy-Induced Cytopenia.
Alyamany R, Alnughmush A, Alzahrani H, Alfayez M. · · 2024 · cited 2× · PMID 39727719 · DOI 10.3390/curroncol31120596
Verify or expand the search:
- PubMed search for NCT05768997
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Anemia
Currently open trials in the same condition.
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- NCT07328191 — Quality of Life-Guided Transfusion in Refractory MDS or AML · NA · recruiting
- NCT07315295 — Maximizing the Benefits of Iron in Ready-to-Use Therapeutic Foods for Malnourished Children in Kenya · NA · recruiting
- NCT07400796 — Assessing Health System Readiness for Scaling Antenatal MMS in Cambodia · recruiting
Other Hallym University Medical Center trials
Trials by the same sponsor.
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- NCT06175169 — IA Model for Acute Appendicitis in CT · NA · unknown
- NCT05439993 — Tepotinib Plus Paclitaxel in MET Amplified or MET Exon 14 Alterated Gastric and GEJ Carcinoma · Phase 1, PHASE2 · recruiting
- NCT04787354 — Optimal Duration of Oxaliplatin in Adjuvant XELOX for Gastric Cancer Patients (EXODOX) · Phase 3 · recruiting
- NCT04192734 — Retrospective Study of Ramucirumab and Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma · 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 NCT05768997 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hallym University Medical Center
- Last refreshed: 15 March 2023
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/NCT05768997.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing