Correction Study of R744 in Renal Anemia Patients on Hemodialysis

Phase 3

Completed

• Conditions: Hemodialysis Patients
• Interventions: Drug: R744

• Registration Number: NCT00433693
• Lead Sponsor: Chugai Pharmaceutical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-02-09
• Study First Submitted QC: 2007-02-09
• Study First Posted: 2007-02-12
• Primary Completion: 2008-03
• Study Completion: 2008-10
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-29
• Last Update Posted: 2009-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	R744	-

Primary Outcome Measures

Name	Time	Method
The ratio of patients whose Hb concentration reach ≥ 10.0g/dL and increasing amount of Hb concentration reach ≥ 1.0g/dL	26 weeks

Secondary Outcome Measures

Name	Time	Method
dose transition of study drug	26 weeks
Adverse events	26 weeks
Regression line of Hb concentration per week	26 weeks
Achievement rate of Hb concentration of ≥ 11.0 g/dL	26 weeks
Time required for reaching Hb concentration of ≥ 10.0 g/dL and reaching increasing amount of Hb concentration ≥ 1.0g/dL	26 weeks
Laboratory measurements	26 weeks
Anti-R744 antibody titer	26 weeks
Transition of Hb concentration	26 weeks
Variation of QOL	26 weeks
Vital signs, standard 12-lead ECG	26 weeks

Trial Locations

Locations (6)

Chugoku/Shikoku region; 🇯🇵 Chugoku/Shikoku, Japan

Chubu region; 🇯🇵 Chubu, Japan

Hokkaido/Tohoku region; 🇯🇵 Hokkaido/Tohoku, Japan

Kanto/Koshinetsu region; 🇯🇵 Kanto/Koshinetsu, Japan

Kinki/Hokuriku region; 🇯🇵 Kinki/Hokuriku, Japan

Kyusyu region; 🇯🇵 Kyusyu, Japan