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NCT05220800: NAIDIC
Effects of Intravenous Administered Iron in Non-anemic Iron Deficient Patients With Colorectal Cancer
Phase 2 trial testing Iron(III)isomaltoside in Iron-deficiency in 134 participants. Not yet recruiting.
1 March 2024
Quick facts
| Lead sponsor | Zealand University Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 134 |
| Start date | 1 March 2022 |
| Primary completion | 1 March 2024 |
| Estimated completion | 1 March 2029 |
| Sites | 3 locations across Denmark |
Drugs / interventions tested
- Iron(III)isomaltoside — full drug profile →
- Placebo
Conditions studied
- Iron-deficiency — all drugs for Iron-deficiency →
- Colorectal Cancer — all drugs for Colorectal Cancer →
Sponsor
Zealand University Hospital
Who can join
18 and older, any sex, with Iron-deficiency or Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This double-blinded clinical randomized trial with a 1:1 recruitment ratio between placebo and the active group will aim to investigate the effects of intravenously administered iron in non-anemic iron deficient patients on physical capacity, immunological cells and their function prior to surgery. A total of 134 patients with colorectalcancer will be included in the study. Study outline: After initial inclusion the patient will undergo baseline testing with cardiopulmonary exercise test (CPET), then followed by an infusion of a weight dependent dosage of iron(III)isomaltoside or placebo. Then at the closest possible time to the surgery the patient will have drawn bloodwork and be re-tested by (CPET). The patient will be followed after surgery with evaluation of several outcomes including quality of recovery and complications. Further, the effects of the intervention on the patients immune function will be evaluated by two different methods: 1) by changes in neutrophil-to-lymphocyte ratio between baseline and preoperative bloodwork and 2) by evaluation mRNA expression in the tumor specimen by the Nanostring pancancer immune panel
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05220800
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Iron-deficiency
Currently open trials in the same condition.
- NCT05407987 — Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery) · Phase 3 · recruiting
- NCT06270498 — Effect of Oral sucRosomIal Iron on exerciSE Capacity and Quality of Life in Patients With Heart Failure · Phase 4 · recruiting
- NCT05913414 — Iron Isomaltide for Iron-deficiency Anemia Patients With Locally Advanced Nasopharyngeal Carcinoma · Phase 2 · recruiting
- NCT05340465 — Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants · Phase 2 · recruiting
- NCT07083492 — Non-invasive Detection of Iron Deficiency in Obstetrics · recruiting
Other Zealand University Hospital trials
Trials by the same sponsor.
- NCT07373561 — Post-Intensive Care Syndrome and Associated Symptom Burden Among Danish ICU Survivors · not yet recruiting
- NCT07386080 — Carbergoline for Antipsychotic Induced Hyperprolactinemia. · Phase 4 · not yet recruiting
- NCT07482150 — The Connect Trial: Connecting Hospital Patients to Alcohol Care · NA · not yet recruiting
- NCT07460999 — Singing Training vs Usual Care 6-18 Months After Surgical Resection for Non-small Cell Lung Cancer (NSCLC) · NA · recruiting
- NCT07365527 — Sonoporation and Tumor Microenvironment Response in Colorectal Liver Metastases · NA · recruiting
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 NCT05220800 (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 Zealand University Hospital
- Last refreshed: 3 March 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/NCT05220800.
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