Clinical Study of R744 to Predialysis Patients - Full Text View

Sponsored by:	Chugai Pharmaceutical
Information provided by:	Chugai Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00433615

Purpose

This study will assess the efficacy and safety of subcutaneous or intravenous R744 in renal anemia patients on Predialysis.

Condition	Intervention	Phase
Anemia in Pre-Dialysis Patients	Drug: R744	Phase III

MedlinePlus related topics: Anemia

Drug Information available for: Epoetin alfa Erythropoietin Epoetin beta

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Switch and Maintenance Study of Subcutaneous or Intravenous Injections of R744 to Predialysis Patients ( Phase Ⅲ Study ).

Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:

Ratio of Maintenance of target Hb　concentration [ Time Frame: 24th and 48th week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Slope of regression line of Hb concentration (g/dL/week) [ Time Frame: 24th week ] [ Designated as safety issue: No ]
Rate of patients who maintain Hb concentration in the range of baseline ± 1.0g/dL [ Time Frame: 24th week ] [ Designated as safety issue: No ]
Ratio of Maintenance of Hb　concentration [ Time Frame: 24th and 48th week ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: 24th and 48th week ] [ Designated as safety issue: Yes ]
Laboratory measurements [ Time Frame: 24th and 48th week ] [ Designated as safety issue: Yes ]
Vital signs, standard 12-lead ECG [ Time Frame: 24th and 48th week ] [ Designated as safety issue: Yes ]
Anti-R744 antibody titer [ Time Frame: 24th and 48th week ] [ Designated as safety issue: Yes ]

Enrollment:	124
Study Start Date:	February 2007
Estimated Study Completion Date:	November 2008
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: R744 100μg(s.c./i.v.)/4 week for 8 weeks, then 25~400μg(s.c./i.v.)/4 week for 40 weeks
2: Experimental	Drug: R744 150μg(s.c./i.v.)/4 week for 8 weeks, then 25~400μg(s.c./i.v.)/4 week for 40 weeks

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 receiving a rHuEPO preparation at least once a month for at least 8 weeks before registration
Patients whose mean value of Hb concentrations determined within 8 weeks before registration has been between ≥ 10.0 g/dL and <13.0 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 who are applicable to the following criteria ⅰ), ⅱ), ⅲ), and whose mean value of Hb concentrations determined within 8 weeks before registration has been > 12.0 g/dL
ⅰ)Patients with an anamnesis of myocardial infarction, pulmonary infarction or cerebral infarction (excluding asymptomatic cerebral infarction)
ⅱ)Patients with complication of unstable angina pectoris or controlled angina pectoris (hardly controlled regardless of drug treatment or interventional treatment )
ⅲ)Patients with congestive cardiac failure (≥ Class II in Fontaine arteriosclerosis obliterans classification)
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 sub-investigator

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00433615

Locations

Japan
Chubu region
Chubu, Japan
Chugoku/Shikoku region
Chugoku/Shikoku, Japan
Hokkaido/Tohoku region
Hokkaido/Tohoku, Japan
Kyusyu region
Kyusyu, Japan
Kinki/Hokuriku region
Kinki/Hokuriku, Japan
Kanto/Koshinetsu region
Kanto/Koshinetsu, Japan

Sponsors and Collaborators

Chugai Pharmaceutical

Investigators

Study Chair:

Takanori Baba

Clinical Research Department 2

More Information

Responsible Party:	Chugai Pharmaceutical ( Chugai Pharmaceutical )
Study ID Numbers:	JH20566
Study First Received:	February 9, 2007
Last Updated:	August 6, 2008
ClinicalTrials.gov Identifier:	NCT00433615
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Epoetin Alfa
Anemia

ClinicalTrials.gov processed this record on January 16, 2009