Clinical Study of R744 to Predialysis Patients

Chugai Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Anemia in Pre-Dialysis Patients

Treatments

Drug: R744

Study type

Interventional

Funder types

Industry

Identifiers

NCT00433615

JH20566

Details and patient eligibility

About

This study will assess the efficacy and safety of subcutaneous or intravenous R744 in renal anemia patients on Predialysis.

Enrollment

124 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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