Hemodialysis Patients
Conditions
Brief summary
This study will assess the efficacy and safety of intravenous R744 in renal anemia patients on hemodialysis.
Interventions
DRUGR744
50μg(i.v.)/2 week until Hb concentration reaches to 11.0g/dL or above, then 25\ 300μg(i.v.)/4 week
Sponsors
Chugai Pharmaceutical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who have been receiving hemodialysis more than 1 time a week * Patients aged ≥ 20 years at the time of obtaining consent * After starting of hemodialysis, patients who have not received rHuEPO preparation * After starting of hemodialysis, patients whose value of Hb concentrations determined before the first hemodialysis during the last week prior to the registration has been \< 10.0 g/dL
Exclusion criteria
* Patients with hardly controllable hypertension (patients whose diastolic blood pressure has been ≥ 100 mmHg on more than 1/3 of the determining occasions after starting of hemodialysis during the last week before registration) * Patients with congestive cardiac failure (≥ Class III in NYHA cardiac function classification) * Female patients who are pregnant, lactating, possibly pregnant or not willing to take a contraceptive measure during the period from the day of starting the treatment with the study drug to 90 days after the day of the last dose of the study drug * Patients with complication of myocardial infarction, pulmonary infarction or cerebral infarction (excluding asymptomatic cerebral infarction) * Patients confirmed to have serious allergy or serious drug allergy (shock, anaphylactoid symptom) * Patients hypersensitive to a rHuEPO preparation * Patients with malignant tumor (including hemic malignant tumor), severe infection, systemic hemic disease (osteomyelodysplasia syndrome, hemoglobinopathy, etc.), hemolytic anemia or apparent hemorrhagic lesion such as digestive tract hemorrhage * Patients who have received an anabolic hormone preparation, testosterone enanthate or mepitiostane within 12 weeks before registration * Patients who have received another investigational drug within 12 weeks before registration * Patients who have received R744 before registration * Patients whose AST(GOT) value ≥ 100 IU/L or ALT(GPT) value ≥ 100 IU/L before registration * Patients who have received erythrocyte transfusion within 16 weeks before registration * Patients for whom a surgical operation involved with heavy bleeding is planned during the study period * In addition, patients who are judged as ineligible to participate in this study by the investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ratio of patients whose Hb concentration reach ≥ 10.0g/dL and increasing amount of Hb concentration reach ≥ 1.0g/dL | 26 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Regression line of Hb concentration per week | 26 weeks |
| Achievement rate of Hb concentration of ≥ 11.0 g/dL | 26 weeks |
| Transition of Hb concentration | 26 weeks |
| dose transition of study drug | 26 weeks |
| Time required for reaching Hb concentration of ≥ 10.0 g/dL and reaching increasing amount of Hb concentration ≥ 1.0g/dL | 26 weeks |
| Adverse events | 26 weeks |
| Laboratory measurements | 26 weeks |
| Vital signs, standard 12-lead ECG | 26 weeks |
| Anti-R744 antibody titer | 26 weeks |
| Variation of QOL | 26 weeks |
Countries
Japan
Outcome results
None listed