Erythropoietin and Iron Supplementation for Patients With Chemotherapy-induced Anaemia
NCT02731378 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 603
Last updated 2016-11-01
Summary
A multicentre, randomized, open-label, parallel-group, active controlled non-inferiority study
Conditions
- Chemotherapy-induced Anaemia
Interventions
- DRUG
-
Erythropoietins (EPO)
A routine dose 10,000 IU of EPO, three times weekly by subcutaneous injections.
- DRUG
-
Aggressive iron dextran supplementation
Iron dextran 100 mg, BIW, through 90 minutes of IV infusion, for the first consecutive 5 weeks
- DRUG
-
Erythropoietins (EPO)
Doubling EPO dosage to 20,000 IU, three times weekly by subcutaneous injections with a maximum of 5 doses
- DRUG
-
Sustained iron dextran supplementation
Iron dextran 200 mg, Q3W, through 90 minutes of IV infusion and a maximum of 5 doses
Sponsors & Collaborators
-
Shanghai East Hospital
lead OTHER
Principal Investigators
-
Yong Gao, PhD · Shanghai East Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-12-31
- Primary Completion
- 2019-04-30
- Completion
- 2019-11-30
Countries
- China
Study Locations
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