Mode
Text Size
Log in / Sign up
Phase 3 Completed N=350 Randomized Treatment

A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)

Non-myeloid Malignancies · Chemotherapy Induced Anaemia
Source: ClinicalTrials.gov NCT01145638 ↗
Enrolled (actual)
350
Serious AEs
14.7%
Results posted
Dec 2015
Primary outcomePrimary: Change in Hb Concentration — 0.48; 0.44 g/dL

Summary

The purpose of this study is to compare the efficacy and safety of intravenous iron therapy with oral iron therapy in patients with cancer and chemotherapy induced anaemia.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Hb Concentration
0.48; 0.44
SECONDARY
Change in Hemoglobin From Baseline to Week 24
1.60; 1.78

Eligibility Criteria

Inclusion Criteria

  • Men and women, aged more than 18 years.
  • Subjects diagnosed with cancer (non-myeloid malignancies) receiving chemotherapy at least 1 day prior to screening and who are going to receive at least two more chemotherapy cycles.
  • Hb 3 times upper normal limit).
  • Active acute or chronic infections (assessed by clinical judgement and if deemed necessary by investigator supplied with white blood cells (WBC) and C-reactive protein (CRP)).
  • Rheumatoid arthritis with symptoms or signs of active joint inflammation.
  • Pregnancy and nursing (To avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product: Contraceptive pills, intrauterine devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches).
  • Planned elective surgery during the study.
  • Participation in any other clinical study (except chemotherapy protocol) within 3 months prior to screening.
  • Known intolerance to oral iron treatment.
  • Untreated B12 or folate deficiency.
  • Any other medical condition that, in the opinion of Principal Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study. Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01145638). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

Back to search