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

This study has been completed.
Information provided by:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
First received: February 9, 2007
Last updated: January 29, 2009
Last verified: January 2009
This study will assess the efficacy and safety of intravenous R744 in renal anemia patients on hemodialysis.

Condition Intervention Phase
Hemodialysis Patients
Drug: R744
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study of Switching From rHuEPO to R744 and Maintenance Treatment With R744 in Renal Anemia Patients on Hemodialysis (Phase Ⅲ Study)

Resource links provided by NLM:

Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:
  • Rate of patients who maintain Hb concentration in the range of ≥ 10.0g/dL and ≤ 12.0g/dL [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Slope of regression line of Hb concentration (g/dL/week) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Rate of patients who maintain Hb concentration in the range of baseline* ± 1.0g/dL [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Rate of patients who maintain Hb concentration in the range of ≥ 10.0g/dL and < 13.0g/dL [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Laboratory measurements [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Vital signs, standard 12-lead ECG [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Anti-R744 antibody titer [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 179
Study Start Date: January 2007
Study Completion Date: October 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: R744
100μg/4 weeks for 8 weeks,then 25~400μg/4 weeks for 40 weeks
Experimental: 2 Drug: R744
150μg/4 weeks for 8 weeks,then 25~400μg/4 weeks for 40 weeks


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00433888

Chubu region
Chubu, Japan
Chugoku/Shikoku region
Chugoku/Shikoku, Japan
Hokkaido/Tohoku region
Hokkaido/Tohoku, Japan
Kanto/Koshinetsu region
Kanto/Koshinetsu, Japan
Kinki/Hokuriku region
Kinki/Hokuriku, Japan
Kyusyu region
Kyusyu, Japan
Sponsors and Collaborators
Chugai Pharmaceutical
Study Chair: Takanori Baba Clinical Research Department 2
  More Information

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00433888     History of Changes
Other Study ID Numbers: JH20563 
Study First Received: February 9, 2007
Last Updated: January 29, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

ClinicalTrials.gov processed this record on May 26, 2016