Clinical Study of R744 to Predialysis Patients( Phase III, Comparative Study in Comparison With Epoetin Beta)

Correction and Maintenance Study of Subcutaneous Injections of R744 to Predialysis Patients ( Phase III, Comparative Study in Comparison With Epoetin Beta)

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

Study Overview

• Status: Completed
• Conditions: Predialysis Patients
• Intervention / Treatment: Drug: Epoetin beta; Drug: R744

• Study Type: Interventional
• Enrollment (Actual): 187
• 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 not receiving a rHuEPO preparation at least 16 weeks before registration
• Patients whose value of Hb concentrations determined the nearest week before registration has been < 10.0 g/dL
• 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: 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; 25μg(s.c.)/2weeks until Hb concentration reaches to 10g/dL or above and the increasing amount of Hb concentration reaches to 1.0g/dL or above, then 25~250μg(s.c.)/4week for 24~26weeks in total.
Active Comparator: 2	Drug: Epoetin beta; 6000IU(s.c.)/week until Hb concentration reaches to 10.0g/dL or above and the increasing amount of Hb concentration reaches to 1.0g/dL or above,then 3000k~12000IU(s.c.)/2week for 24~26weeks in total.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of patients who maintain mean Hb concentration in the range of ≥ 10.0g/dL and ≤ 12.0g/dL	26 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events	26 weeks
Mean Hb concentration for term of evaluation	26 weeks
The ratio of patients whose Hb concentration reach ≥ 10.0g/dL and increasing amount of Hb concentration reach ≥ 1.0g/dL	26 weeks
Time required for reaching Hb concentration of ≥ 10.0 g/dL and reaching increasing amount of Hb concentration of ≥ 1.0g/dL	26 weeks
Slope of regression line of Hb concentration per week	26 weeks
Variation of QOL	26 weeks
Laboratory measurements	26 weeks
Vital signs, standard 12-lead ECG	26 weeks
Anti-R744 antibody titer	26 weeks
Anti-Epoetin beta antibody titer	26 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: June 26, 2007
• First Submitted That Met QC Criteria: June 26, 2007
• First Posted (Estimate): June 27, 2007

Study Record Updates

• Last Update Posted (Estimate): January 8, 2009
• Last Update Submitted That Met QC Criteria: January 6, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematinics; Epoetin Alfa
• Other Study ID Numbers: JH20565