Correction Study of R744 in Renal Anemia Patients on Hemodialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00433693
Recruitment Status : Completed
First Posted : February 12, 2007
Last Update Posted : February 2, 2009
Information provided by:
Chugai Pharmaceutical

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
Hemodialysis Patients Drug: R744 Phase 3

Study Type : Interventional  (Clinical Trial)
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 : February 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
U.S. FDA Resources

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 Name: methoxy polyethylene glycol-epoetin beta

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 [ Time Frame: 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 [ Time Frame: 26 weeks ]
  2. Regression line of Hb concentration per week [ Time Frame: 26 weeks ]
  3. Achievement rate of Hb concentration of ≥ 11.0 g/dL [ Time Frame: 26 weeks ]
  4. Transition of Hb concentration [ Time Frame: 26 weeks ]
  5. dose transition of study drug [ Time Frame: 26 weeks ]
  6. Variation of QOL [ Time Frame: 26 weeks ]
  7. Adverse events [ Time Frame: 26 weeks ]
  8. Laboratory measurements [ Time Frame: 26 weeks ]
  9. Vital signs, standard 12-lead ECG [ Time Frame: 26 weeks ]
  10. Anti-R744 antibody titer [ Time Frame: 26 weeks ]

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00433693

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

Responsible Party: Chugai Pharmaceutical Identifier: NCT00433693     History of Changes
Other Study ID Numbers: JH20562
First Posted: February 12, 2007    Key Record Dates
Last Update Posted: February 2, 2009
Last Verified: January 2009