Switch and Maintenance Study of Intravenous Injections of R744 to Hemodialysis Patients (Phase Ⅲ Study)

NCT ID: NCT00433888

Last Updated: 2009-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 179 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2008-10-31

Brief Summary

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

Conditions

Hemodialysis Patients

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

R744

Intervention Type: DRUG

100μg/4 weeks for 8 weeks,then 25\~400μg/4 weeks for 40 weeks

2

Group Type: EXPERIMENTAL

R744

Intervention Type: DRUG

150μg/4 weeks for 8 weeks,then 25\~400μg/4 weeks for 40 weeks

Interventions

R744

100μg/4 weeks for 8 weeks,then 25\~400μg/4 weeks for 40 weeks

Intervention Type: DRUG

R744

150μg/4 weeks for 8 weeks,then 25\~400μg/4 weeks for 40 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who have been receiving hemodialysis 3 times a week for at least 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 week for at least 8 weeks before registration
• Patients whose mean value of Hb concentrations determined before the first dialysis of each week within 8 weeks prior to the registration has been between ≥ 10.0 g/dL and <12.0 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 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 the last 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chugai Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Chugai Pharmaceutical

Principal Investigators

Takanori Baba

Role: STUDY_CHAIR

Clinical Research Department 2

Locations

Chugoku/Shikoku region

Chugoku/Shikoku, , Japan

Chubu region

Chūbu, , Japan

Hokkaido/Tohoku region

Hokkaido/Tohoku, , Japan

Kanto/Koshinetsu region

Kanto/Koshinetsu, , Japan

Kinki/Hokuriku region

Kinki/Hokuriku, , Japan

Kyusyu region

Kyusyu, , Japan

Countries

Japan

Other Identifiers

JH20563

Identifier Type: -

Identifier Source: org_study_id