Switch and Maintenance Study of Intravenous Injections of R744 to Hemodialysis Patients (Phase Ⅲ Study)

Hemodialysis Patients Clinical Trial

Official title:

Clinical Study of Switching From rHuEPO to R744 and Maintenance Treatment With R744 in Renal Anemia Patients on Hemodialysis (Phase Ⅲ Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00433888
• Other study ID #: JH20563
• Status: Completed
• Phase: Phase 3
• First received: February 9, 2007
• Last updated: January 29, 2009
• Start date: January 2007
• Est. completion date: October 2008

Study information

• Verified date: January 2009
• Source: Chugai Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: October 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients who have been receiving hemodialysis 3 times a week for at least 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 week for at least 8 weeks before registration

• Patients whose mean value of Hb concentrations determined before the first dialysis of each week within 8 weeks prior to the registration has been between = 10.0 g/dL and <12.0 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 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 the last 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodialysis Patients

Intervention

Drug:
• R744
100µg/4 weeks for 8 weeks,then 25~400µg/4 weeks for 40 weeks
• R744
150µg/4 weeks for 8 weeks,then 25~400µg/4 weeks for 40 weeks

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Chugai Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients who maintain Hb concentration in the range of = 10.0g/dL and = 12.0g/dL		48 weeks	No
Secondary	Slope of regression line of Hb concentration (g/dL/week)		48 weeks	No
Secondary	Rate of patients who maintain Hb concentration in the range of baseline* ± 1.0g/dL		48 weeks	No
Secondary	Rate of patients who maintain Hb concentration in the range of = 10.0g/dL and < 13.0g/dL		48 weeks	No
Secondary	Adverse events		48 weeks	Yes
Secondary	Laboratory measurements		48 weeks	Yes
Secondary	Vital signs, standard 12-lead ECG		48 weeks	Yes
Secondary	Anti-R744 antibody titer		48 weeks	Yes