Correction Study of R744 in Renal Anemia Patients on Hemodialysis

NCT ID: NCT00433693

Last Updated: 2009-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• 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: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

R744

Intervention Type: DRUG

50μg(i.v.)/2 week until Hb concentration reaches to 11.0g/dL or above, then 25\~300μg(i.v.)/4 week

Interventions

R744

50μg(i.v.)/2 week until Hb concentration reaches to 11.0g/dL or above, then 25\~300μg(i.v.)/4 week

Intervention Type: DRUG

Other Intervention Names

methoxy polyethylene glycol-epoetin beta

Eligibility Criteria

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

• 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

JH20562

Identifier Type: -

Identifier Source: org_study_id