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

This study has been completed.
Sponsor:
Information provided by:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00492427
First received: June 26, 2007
Last updated: January 6, 2009
Last verified: January 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Hb concentration for term of evaluation [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • 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 ]
  • 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 ] [ Designated as safety issue: No ]
  • Slope of regression line of Hb concentration per week [ 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 ]
  • Anti-Epoetin beta antibody titer [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Takanori Baba, Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00492427     History of Changes
Other Study ID Numbers: JH20565
Study First Received: June 26, 2007
Last Updated: January 6, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014