Switch and Maintenance Study of Intravenous Injections of R744 to Hemodialysis Patients (Phase Ⅲ Study)

Clinical Study of Switching From rHuEPO to R744 and Maintenance Treatment With R744 in Renal Anemia Patients on Hemodialysis (Phase Ⅲ Study)

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

Study Overview

• Status: Completed
• Conditions: Hemodialysis Patients
• Intervention / Treatment: Drug: R744; Drug: R744

• Study Type: Interventional
• Enrollment (Actual): 179
• 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 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
• Patients whose mean value of Hb concentrations determined before the first dialysis of each week within 8 weeks prior to the registration has been between ≥ 10.0 g/dL and <12.0 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 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 the last 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 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/4 weeks for 8 weeks,then 25~400μg/4 weeks for 40 weeks; Drug: R744; 150μg/4 weeks for 8 weeks,then 25~400μg/4 weeks for 40 weeks
Experimental: 2	Drug: R744; 100μg/4 weeks for 8 weeks,then 25~400μg/4 weeks for 40 weeks; Drug: R744; 150μg/4 weeks for 8 weeks,then 25~400μg/4 weeks for 40 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of patients who maintain Hb concentration in the range of ≥ 10.0g/dL and ≤ 12.0g/dL	48 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events	48 weeks
Slope of regression line of Hb concentration (g/dL/week)	48 weeks
Rate of patients who maintain Hb concentration in the range of ≥ 10.0g/dL and < 13.0g/dL	48 weeks
Laboratory measurements	48 weeks
Anti-R744 antibody titer	48 weeks
Vital signs, standard 12-lead ECG	48 weeks
Rate of patients who maintain Hb concentration in the range of baseline* ± 1.0g/dL	48 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): October 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

• Other Study ID Numbers: JH20563