Correction Study of R744 in Renal Anemia Patients on Hemodialysis - Full Text View

Sponsored by:	Chugai Pharmaceutical
Information provided by:	Chugai Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00433693

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 III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Correction Study of Intravenous Injections of R744 to Hemodialysis Patients ( Phase Ⅲ Study ).

Resource links provided by NLM:

MedlinePlus related topics: Anemia Dialysis Kidney Failure

U.S. FDA Resources

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
1: Experimental	Drug: R744 50μg(i.v.)/2 week until Hb concentration reaches to 11.0g/dL or above, then 25~300μg(i.v.)/4 week

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
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

No publications provided

Responsible Party:	Chugai Pharmaceutical ( Chugai Pharmaceutical )
Study ID Numbers:	JH20562
Study First Received:	February 9, 2007
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00433693 History of Changes
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 September 02, 2009