Clinical Study of R744 to Hemodialysis Patients

Hemodialysis Patients Clinical Trial

Official title:

Switch and Maintenance Study of Intravenous Injections of R744 to Hemodialysis Patients ( Phase III, Double Blind Study in Comparison With Epoetin Beta).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00491868
• Other study ID #: JH20876
• Status: Completed
• Phase: Phase 3
• First received: June 25, 2007
• Last updated: January 29, 2009
• Start date: June 2007
• Est. completion date: August 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 used as the comparative drug (epoetin beta) will assess the efficacy and safety of intravenous injections of R744 in renal anemia patients on Hemodialysis patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: August 2008
• Est. primary completion date: May 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

• Within 4 weeks before registration, patients who have been receiving a rHuEPO preparation 750IU (3 times a week), 1,500IU (twice a week (1st and 2nd hemodialysis day of the week, or1st and 3rd hemodialysis day of the week)), 1,500IU (3 times a week), or 3,000IU (twice a week (1st and 2nd hemodialysis day of the week, or1st and 3rd hemodialysis day of the week)), and patients who have not change dosage and administration.

• Patients whose pre-dialysis Hb concentrations has been between = 9.0 g/dL and =12.0 g/dL and mean value of pre-dialysis Hb concentrations has been between = 9.5 g/dL and =11.5 g/dL determined at the beginning of each week within 8 weeks before registration

• 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, testosterone propionate, methyltestosterone 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodialysis Patients

Intervention

Drug:
• R744
100µg/4week for 8 weeks, then 50~250µg/4week for 16 weeks
• R744
150µg/4week for 8 weeks, then 50~250µg/4week for 16 weeks
• rHuEPO
2250IU or 3000IU(i.v.) 2 or 3 times/week for 8 weeks, then 750~9000IU(i.v.)/1~3week for 16 weeks
• rHuEPO
4500IU or 6000IU(i.v.) 2 or 3times/week for 8 weeks, then 750~9000IU(i.v.)/1~3week for 16 weeks
• R744 placebo
0 µg/4week for 24 weeks
• rHuEPO placebo
0 IU 2 or 3 times/week for 8 weeks, then 1~3 times/week for 16 weeks

Locations

Country	Name	City	State
Japan	Chubu region	Chubu
Japan	Chugoku/Shikoku region	Chugoku/Shikoku
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	Variation of Hb concentration from baseline Hb concentration in evaluation period		week 17~24	No
Secondary	Rate of patients who maintain Hb concentration in the range of baseline ± 1.0g/dL and maintain Hb concentration in the range of = 9.0g/dL and = 12.0g/dL in evaluation period		week 17~24	No
Secondary	Rate of patients who maintain Hb concentration within ±1.0g/dL of reference Hb		week 17~24	No
Secondary	Adverse events		throughout study	Yes
Secondary	Laboratory measurements		throughout study	Yes
Secondary	Vital signs, standard 12-lead ECG		throughout study	Yes
Secondary	Anti-R744 antibody titer		throughout study	Yes
Secondary	Anti-Epoetin beta antibody titer		throughout study	Yes