Intravenous Iron Injection in Cancer Patients With Anemia

NCT04187716 | Unknown Phase 3

• 1 other identifier: 2019-04-182-005
• Study Type: interventional
• Target: 341
• Locations: 1 country
• Sites: 1

Brief Summary

• Multifactorial pathogenesis is involved in anemia of cancer patients and defining the causes of anemia is not always simple.
• Currently, treatment options available for anemia in cancer patients include red blood cell (RBC) transfusion, erythropoietin stimulating agent (ESA), and iron supplementation, accompanying considerable pros and cons for each treatment.
• Previous studies have demonstrated benefit when treating with IV iron in combination with ESA and, more recently, evidence is emerging to suggest a role for IV iron alone.
• In this study, investigator will assess the efficacy of intravenous iron for the treatment of anemia in cancer patients.
• Improvement of anemia and the improvement of quality of life compared to conservative treatment of intravenous iron

Conditions

Cancer Anaemia

Outcome Measures

Primary Outcomes (1)

• The hemoglobin response is compared in patients treated with intravenous iron (Ferinject) and in conservatively treated patients.

  13 months

Study Arms (2)

Ferinject

EXPERIMENTAL

For patients undergoing chemotherapy, ferinject 1000mg will be injected within 24 hours or 24 hours after day 1 of the next chemotherapy cycle. Patients using targeted therapies can be dosed at any time after recognizing Hb 8.0-10.5g / dL and injecting 1000 mg of ferinject.

Drug: Ferinject

remedies

OTHER

Treatment for anemia will include remedies such as iron (oral or intravenous), hematopoietic accelerators, and blood transfusions, and will be determined by researchers at each institution to provide optimal treatment for patients.

Drug: Ferinject

Interventions

Ferinject DRUG

For patients undergoing chemotherapy, ferinject 1000mg will be injected within 24 hours or 24 hours after day 1 of the next chemotherapy cycle. Patients using targeted therapies can be dosed at any time after recognizing Hb 8.0-10.5g / dL and injecting 1000 mg of ferinject.

Ferinject; remedies

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject should be diagnosed with solid cancer or lymphoma. Hemoglobin level of test subject should be in the range of 8.0-10.5g / dL, or he / she has experienced hemoglobin reduction of 2g / dL or more during chemotherapy.

You may not qualify if:

• The patients have a history of iron (oral or intravenous), hematopoietic stimulating agents (ESA), and dialysis within 4 weeks of study enrollment.
• There is evidence that the patient's disease is a bone marrow invasion. There is a hypersensitivity reaction to ferinject or the components of ferinject.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Interventions

ferric carboxymaltose

Study Officials

• JunHo Jang, ph.D

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JunHO Jang, ph.D

CONTACT

82-2-3410-0918; jh21.jang@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 5, 2019
• Study Start: February 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 22, 2020

Record last verified: 2020-01

Locations

KR (1)