We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Study of R744 to Predialysis Patients( Phase III, Comparative Study in Comparison With Epoetin Beta)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00492427
First Posted: June 27, 2007
Last Update Posted: January 8, 2009
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.
Information provided by:
Chugai Pharmaceutical
  Purpose
This study used as the comparative drug (epoetin beta) will assess the efficacy and safety of subcutaneous R744 in renal anemia patients on Predialysis.

Condition Intervention Phase
Predialysis Patients Drug: R744 Drug: Epoetin beta Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Correction and Maintenance Study of Subcutaneous Injections of R744 to Predialysis Patients ( Phase III, Comparative Study in Comparison With Epoetin Beta)

Resource links provided by NLM:


Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:
  • Rate of patients who maintain mean Hb concentration in the range of ≥ 10.0g/dL and ≤ 12.0g/dL [ Time Frame: 26 weeks ]

Secondary Outcome Measures:
  • Mean Hb concentration for term of evaluation [ Time Frame: 26 weeks ]
  • 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 ]
  • Time required for reaching Hb concentration of ≥ 10.0 g/dL and reaching increasing amount of Hb concentration of ≥ 1.0g/dL [ Time Frame: 26 weeks ]
  • Slope of regression line of Hb concentration per week [ Time Frame: 26 weeks ]
  • Variation of QOL [ Time Frame: 26 weeks ]
  • Adverse events [ Time Frame: 26 weeks ]
  • Laboratory measurements [ Time Frame: 26 weeks ]
  • Vital signs, standard 12-lead ECG [ Time Frame: 26 weeks ]
  • Anti-R744 antibody titer [ Time Frame: 26 weeks ]
  • Anti-Epoetin beta antibody titer [ Time Frame: 26 weeks ]

Enrollment: 187
Study Start Date: June 2007
Study Completion Date: November 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2 Drug: Epoetin beta
6000IU(s.c.)/week until Hb concentration reaches to 10.0g/dL or above and the increasing amount of Hb concentration reaches to 1.0g/dL or above,then 3000k~12000IU(s.c.)/2week for 24~26weeks in total.
Experimental: 1 Drug: R744
25μg(s.c.)/2weeks until Hb concentration reaches to 10g/dL or above and the increasing amount of Hb concentration reaches to 1.0g/dL or above, then 25~250μg(s.c.)/4week for 24~26weeks in total.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Patients whose serum creatinine level has been ≥ 2.0 mg/dL or creatinine clearance has been ≤ 30 mL /min at any one time point within 12 weeks before registration
  • Patients aged ≥ 20 years at the time of obtaining consent
  • Patients who have been not receiving a rHuEPO preparation at least 16 weeks before registration
  • Patients whose value of Hb concentrations determined the nearest week before registration has been < 10.0 g/dL
  • Patients whose transferrin saturation has been ≥ 20 % or ferritin has been ≥ 100ng/mL at any 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 16 weeks before registration
  • Patients for whom a surgical operation accompanied by marked bleeding is planned during the study period
  • In addition, patients who are judged as ineligible to participate in this study by the investigator or subinvestigator
  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): NCT00492427


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 Chugai Pharmaceutical,Clinical Research Department 2
  More Information

Responsible Party: Takanori Baba, Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00492427     History of Changes
Other Study ID Numbers: JH20565
First Submitted: June 26, 2007
First Posted: June 27, 2007
Last Update Posted: January 8, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Epoetin Alfa
Hematinics