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

This study has been completed.
Sponsor:
Information provided by:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00433888
First received: February 9, 2007
Last updated: January 29, 2009
Last verified: January 2009

February 9, 2007
January 29, 2009
January 2007
July 2008   (final data collection date for primary outcome measure)
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 ]
Rate of patients who maintain Hb concentration in the range of ≥ 10.0g/dL and ≤ 12.0g/dL
Complete list of historical versions of study NCT00433888 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Efficacy
  • Slope of regression line of Hb concentration (g/dL/week)
  • Rate of patients who maintain Hb concentration in the range of baseline* ± 1.0g/dL
  • Rate of patients who maintain Hb concentration in the range of ≥ 10.0g/dL and < 13.0g/dL
  • Safety
  • Adverse events
  • Laboratory measurements
  • Vital signs, standard 12-lead ECG
  • Anti-R744 antibody titer
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hemodialysis Patients
  • 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: 1
    Intervention: Drug: R744
  • Experimental: 2
    Intervention: Drug: R744
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
179
October 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00433888
JH20563
No
Chugai Pharmaceutical
Chugai Pharmaceutical
Not Provided
Study Chair: Takanori Baba Clinical Research Department 2
Chugai Pharmaceutical
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP