Clinical Study of R744 to Predialysis Patients

Phase 3

Completed

• Conditions: Anemia in Pre-Dialysis Patients
• Interventions: Drug: R744

• Registration Number: NCT00433615
• Lead Sponsor: Chugai Pharmaceutical

Brief Summary

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

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: 2008-11
• Study Completion: 2008-11
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-29
• Last Update Posted: 2009-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	R744	-
1	R744	-

Primary Outcome Measures

Name	Time	Method
Ratio of Maintenance of target Hb concentration	24th and 48th week

Secondary Outcome Measures

Name	Time	Method
Slope of regression line of Hb concentration (g/dL/week)	24th week
Rate of patients who maintain Hb concentration in the range of baseline ± 1.0g/dL	24th week
Ratio of Maintenance of Hb concentration	24th and 48th week
Adverse events	24th and 48th week
Laboratory measurements	24th and 48th week
Vital signs, standard 12-lead ECG	24th and 48th week
Anti-R744 antibody titer	24th and 48th week

Trial Locations

Locations (6)

Chubu region; 🇯🇵 Chubu, Japan

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

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

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

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

Kyusyu region; 🇯🇵 Kyusyu, Japan