Correction Study of R744 in Renal Anemia Patients on Hemodialysis

This study has been completed.
Sponsor:
Information provided by:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00433693
First received: February 9, 2007
Last updated: January 29, 2009
Last verified: January 2009
  Purpose

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: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Correction Study of Intravenous Injections of R744 to Hemodialysis Patients ( Phase Ⅲ Study ).

Resource links provided by NLM:


Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Regression line of Hb concentration per week [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Achievement rate of Hb concentration of ≥ 11.0 g/dL [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Transition of Hb concentration [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • dose transition of study drug [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Variation of QOL [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
  • Laboratory measurements [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
  • Vital signs, standard 12-lead ECG [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
  • Anti-R744 antibody titer [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: February 2007
Study Completion Date: October 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00433693

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

No publications provided

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00433693     History of Changes
Other Study ID Numbers: JH20562
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 April 17, 2014