Anemia in Pre-Dialysis Patients
Conditions
Brief summary
This study will assess the efficacy and safety of subcutaneous or intravenous R744 in renal anemia patients on Predialysis.
Interventions
DRUGR744
100μg(s.c./i.v.)/4 week for 8 weeks, then 25\ 400μg(s.c./i.v.)/4 week for 40 weeks
Sponsors
Chugai Pharmaceutical
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients whose serum creatinine level has been ≥ 2.0 mg/dL or creatinine clearance has been ≥ 30 mL /min at any one time point within 12 weeks before registration * Patients aged ≥ 20 years at the time of obtaining consent * Patients who have been receiving a rHuEPO preparation at least once a month for at least 8 weeks before registration * Patients whose mean value of Hb concentrations determined within 8 weeks before registration has been between ≥ 10.0 g/dL and \<13.0 g/dL * Patients whose transferrin saturation has been ≥ 20 % or ferritin has been ≥ 100ng/mL at any one time point within 8 weeks before registration
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 within 12 weeks 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 in 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 who are applicable to the following criteria ⅰ), ⅱ), ⅲ), and whose mean value of Hb concentrations determined within 8 weeks before registration has been \> 12.0 g/dL * ⅰ)Patients with an anamnesis of myocardial infarction, pulmonary infarction or cerebral infarction (excluding asymptomatic cerebral infarction) * ⅱ)Patients with complication of unstable angina pectoris or controlled angina pectoris (hardly controlled regardless of drug treatment or interventional treatment ) * ⅲ)Patients with congestive cardiac failure (≥ Class II in Fontaine arteriosclerosis obliterans classification) * 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 accompanied by marked 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 |
|---|---|
| Ratio of Maintenance of target Hb concentration | 24th and 48th week |
Secondary
| Measure | Time frame |
|---|---|
| Rate of patients who maintain Hb concentration in the range of baseline ± 1.0g/dL | 24th week |
| Ratio of Maintenance of Hb concentration | 24th and 48th week |
| Adverse events | 24th and 48th week |
| Slope of regression line of Hb concentration (g/dL/week) | 24th week |
| Vital signs, standard 12-lead ECG | 24th and 48th week |
| Anti-R744 antibody titer | 24th and 48th week |
| Laboratory measurements | 24th and 48th week |
Countries
Japan
Outcome results
None listed