Clinical Study of R744 to Hemodialysis Patients

NCT ID: NCT00491868

Last Updated: 2009-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2008-08-31

Brief Summary

This study used as the comparative drug (epoetin beta) will assess the efficacy and safety of intravenous injections of R744 in renal anemia patients on Hemodialysis patients.

Conditions

Hemodialysis Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Group Type: EXPERIMENTAL

R744

Intervention Type: DRUG

100μg/4week for 8 weeks, then 50\~250μg/4week for 16 weeks

rHuEPO placebo

Intervention Type: DRUG

0 IU 2 or 3 times/week for 8 weeks, then 1\~3 times/week for 16 weeks

2

Group Type: EXPERIMENTAL

R744

Intervention Type: DRUG

150μg/4week for 8 weeks, then 50\~250μg/4week for 16 weeks

rHuEPO placebo

Intervention Type: DRUG

0 IU 2 or 3 times/week for 8 weeks, then 1\~3 times/week for 16 weeks

3

Group Type: ACTIVE_COMPARATOR

rHuEPO

Intervention Type: DRUG

2250IU or 3000IU(i.v.) 2 or 3 times/week for 8 weeks, then 750\~9000IU(i.v.)/1\~3week for 16 weeks

R744 placebo

Intervention Type: DRUG

0 μg/4week for 24 weeks

4

Group Type: ACTIVE_COMPARATOR

rHuEPO

Intervention Type: DRUG

4500IU or 6000IU(i.v.) 2 or 3times/week for 8 weeks, then 750\~9000IU(i.v.)/1\~3week for 16 weeks

R744 placebo

Intervention Type: DRUG

0 μg/4week for 24 weeks

Interventions

R744

100μg/4week for 8 weeks, then 50\~250μg/4week for 16 weeks

Intervention Type: DRUG

R744

150μg/4week for 8 weeks, then 50\~250μg/4week for 16 weeks

Intervention Type: DRUG

rHuEPO

2250IU or 3000IU(i.v.) 2 or 3 times/week for 8 weeks, then 750\~9000IU(i.v.)/1\~3week for 16 weeks

Intervention Type: DRUG

rHuEPO

4500IU or 6000IU(i.v.) 2 or 3times/week for 8 weeks, then 750\~9000IU(i.v.)/1\~3week for 16 weeks

Intervention Type: DRUG

R744 placebo

0 μg/4week for 24 weeks

Intervention Type: DRUG

rHuEPO placebo

0 IU 2 or 3 times/week for 8 weeks, then 1\~3 times/week for 16 weeks

Intervention Type: DRUG

Other Intervention Names

methoxy polyethylene glycol-epoetin beta; methoxy polyethylene glycol-epoetin beta

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
• Within 4 weeks before registration, patients who have been receiving a rHuEPO preparation 750IU (3 times a week), 1,500IU (twice a week (1st and 2nd hemodialysis day of the week, or1st and 3rd hemodialysis day of the week)), 1,500IU (3 times a week), or 3,000IU (twice a week (1st and 2nd hemodialysis day of the week, or1st and 3rd hemodialysis day of the week)), and patients who have not change dosage and administration.
• Patients whose pre-dialysis Hb concentrations has been between ≥ 9.0 g/dL and ≤12.0 g/dL and mean value of pre-dialysis Hb concentrations has been between ≥ 9.5 g/dL and ≤11.5 g/dL determined at the beginning of each week within 8 weeks before registration
• Patients whose transferrin saturation has been ≥ 20 % or ferritin has been ≥ 100ng/mL at any 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, testosterone propionate, methyltestosterone 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 subinvestigator

• 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

Chugai Pharmaceutical,Clinical Research Department 2

Locations

Chugoku/Shikoku region

Chugoku/Shikoku, , Japan

Chubu region

Chūbu, , Japan

Kanto/Koshinetsu region

Kanto/Koshinetsu, , Japan

Kinki/Hokuriku region

Kinki/Hokuriku, , Japan

Kyusyu region

Kyusyu, , Japan

Countries

Japan

Other Identifiers

JH20876

Identifier Type: -

Identifier Source: org_study_id