Clinical trial · Interventional
A Dose Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor
A Randomized, Dose - Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor
NCT00359840CI-TRIAL-00007923completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To assess the clinical effective dose of KRN321 administered with once triweekly schedule.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| darbepoetin alfa | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To compare the effectiveness of KRN321(darbepoetin alfa) on the proportion of subjects achieving hemoglobin response
Secondary outcomes (3)
- measure
- To compare the proportion of subjects who receive red blood cell transfusions or show the hemoglobin level below 8 g/dL
- measure
- To compare the proportion of subjects who receive red blood cell transfusions
- measure
- To compare the effectiveness of KRN321 based on quality of life scores
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * patients diagnosed as solid tumor or malignant lymphoma * patients receiving cyclic chemotherapy * written informed consent * hemoglobin concentration below 11 d/dL at enrollment * life expectancy of more than 4 months Exclusion Criteria: * hemolysis, gastrointestinal bleeding, postoperative bleeding * iron deficiency * megaloblastic anemia * received \> 2 RBC transfusions within 4 weeks before randomization or any RBC transfusion within 2 weeks before randomization * any primary hematological disorder that could cause anemia * prior treatment with KRN321 * received erythropoetin therapy within 8 weeks before treatment
References
Publications (0)
Data not yet available
No reference posted for this study.