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Correction Study of R744 in Renal Anemia Patients on Hemodialysis

Sponsor
Chugai Pharmaceutical (Industry)
Overall Status
Completed
CT.gov ID
NCT00433693
Collaborator
(none)
50
Enrollment
6
Locations
1
Arm
20
Duration (Months)
8.3
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Correction Study of Intravenous Injections of R744 to Hemodialysis Patients ( Phase Ⅲ Study ).
Study Start Date :
Feb 1, 2007
Actual Primary Completion Date :
Mar 1, 2008
Actual Study Completion Date :
Oct 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: R744
50μg(i.v.)/2 week until Hb concentration reaches to 11.0g/dL or above, then 25~300μg(i.v.)/4 week
Other Names:
  • methoxy polyethylene glycol-epoetin beta

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The ratio of patients whose Hb concentration reach ≥ 10.0g/dL and increasing amount of Hb concentration reach ≥ 1.0g/dL [26 weeks]

    Secondary Outcome Measures

    1. Time required for reaching Hb concentration of ≥ 10.0 g/dL and reaching increasing amount of Hb concentration ≥ 1.0g/dL [26 weeks]

    2. Regression line of Hb concentration per week [26 weeks]

    3. Achievement rate of Hb concentration of ≥ 11.0 g/dL [26 weeks]

    4. Transition of Hb concentration [26 weeks]

    5. dose transition of study drug [26 weeks]

    6. Variation of QOL [26 weeks]

    7. Adverse events [26 weeks]

    8. Laboratory measurements [26 weeks]

    9. Vital signs, standard 12-lead ECG [26 weeks]

    10. Anti-R744 antibody titer [26 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients who have been receiving hemodialysis more than 1 time a week

    • Patients aged ≥ 20 years at the time of obtaining consent

    • After starting of hemodialysis, patients who have not received rHuEPO preparation

    • After starting of hemodialysis, patients whose value of Hb concentrations determined before the first hemodialysis during the last week prior to the registration has been < 10.0 g/dL

    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 after starting of hemodialysis during the last week 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 during 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 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

    Locations

    Site City State Country Postal Code
    1 Chubu region Chubu Japan
    2 Chugoku/Shikoku region Chugoku/Shikoku Japan
    3 Hokkaido/Tohoku region Hokkaido/Tohoku Japan
    4 Kanto/Koshinetsu region Kanto/Koshinetsu Japan
    5 Kinki/Hokuriku region Kinki/Hokuriku Japan
    6 Kyusyu region Kyusyu Japan

    Sponsors and Collaborators

    • Chugai Pharmaceutical

    Investigators

    • Study Chair: Takanori Baba, Clinical Research Department 2

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00433693
    Other Study ID Numbers:
    • JH20562
    First Posted:
    Feb 12, 2007
    Last Update Posted:
    Feb 2, 2009
    Last Verified:
    Jan 1, 2009

    Study Results

    No Results Posted as of Feb 2, 2009