Clinical Study of R744 to Predialysis Patients

Switch and Maintenance Study of Subcutaneous or Intravenous Injections of R744 to Predialysis Patients ( Phase Ⅲ Study ).

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

Study Overview

• Status: Completed
• Conditions: Anemia in Pre-Dialysis Patients
• Intervention / Treatment: Drug: R744; Drug: R744

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Chubu, Japan
    • Chubu Region
  • Chugoku/Shikoku, Japan
    • Chugoku/Shikoku region
  • Hokkaido/Tohoku, Japan
    • Hokkaido/Tohoku region
  • Kanto/Koshinetsu, Japan
    • Kanto/Koshinetsu region
  • Kinki/Hokuriku, Japan
    • Kinki/Hokuriku region
  • Kyusyu, Japan
    • Kyusyu region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: R744; 100μg(s.c./i.v.)/4 week for 8 weeks, then 25~400μg(s.c./i.v.)/4 week for 40 weeks; Other Names: methoxy polyethylene glycol-epoetin beta; Drug: R744; 150μg(s.c./i.v.)/4 week for 8 weeks, then 25~400μg(s.c./i.v.)/4 week for 40 weeks; Other Names: methoxy polyethylene glycol-epoetin beta
Experimental: 2	Drug: R744; 100μg(s.c./i.v.)/4 week for 8 weeks, then 25~400μg(s.c./i.v.)/4 week for 40 weeks; Other Names: methoxy polyethylene glycol-epoetin beta; Drug: R744; 150μg(s.c./i.v.)/4 week for 8 weeks, then 25~400μg(s.c./i.v.)/4 week for 40 weeks; Other Names: methoxy polyethylene glycol-epoetin beta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ratio of Maintenance of target Hb concentration	24th and 48th week

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Chugai Pharmaceutical
• Investigators: Study Chair: Takanori Baba, Clinical Research Department 2

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: February 9, 2007
• First Submitted That Met QC Criteria: February 9, 2007
• First Posted (Estimate): February 12, 2007

Study Record Updates

• Last Update Posted (Estimate): February 2, 2009
• Last Update Submitted That Met QC Criteria: January 29, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematinics; Epoetin Alfa
• Other Study ID Numbers: JH20566