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

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.
ClinicalTrials.gov Identifier: NCT00433888
Recruitment Status : Completed
First Posted : February 12, 2007
Last Update Posted : February 2, 2009
Sponsor:
Information provided by:

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
Hemodialysis Patients Drug: R744 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : January 2007
Primary Completion Date : July 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Rate of patients who maintain Hb concentration in the range of ≥ 10.0g/dL and ≤ 12.0g/dL [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Slope of regression line of Hb concentration (g/dL/week) [ Time Frame: 48 weeks ]
  2. Rate of patients who maintain Hb concentration in the range of baseline* ± 1.0g/dL [ Time Frame: 48 weeks ]
  3. Rate of patients who maintain Hb concentration in the range of ≥ 10.0g/dL and < 13.0g/dL [ Time Frame: 48 weeks ]
  4. Adverse events [ Time Frame: 48 weeks ]
  5. Laboratory measurements [ Time Frame: 48 weeks ]
  6. Vital signs, standard 12-lead ECG [ Time Frame: 48 weeks ]
  7. Anti-R744 antibody titer [ Time Frame: 48 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT00433888


Locations
Japan
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
Investigators
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
First Posted: February 12, 2007    Key Record Dates
Last Update Posted: February 2, 2009
Last Verified: January 2009