Clinical trial NCT00491868: Clinical Study of R744 to Hemodialysis Patients
Official title: Switch and Maintenance Study of Intravenous Injections of R744 to Hemodialysis Patients ( Phase III, Double Blind Study in Comparison With Epoetin Beta).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemodialysis Patients
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2007-06-26
Enrollment: 134
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Variation of Hb concentration from baseline Hb concentration in evaluation period
timeFrame: week 17~24
Secondary outcomes:
measure: 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
timeFrame: week 17~24
measure: Rate of patients who maintain Hb concentration within ±1.0g/dL of reference Hb
timeFrame: week 17~24
measure: Adverse events
timeFrame: throughout study
measure: Laboratory measurements
timeFrame: throughout study
measure: Vital signs, standard 12-lead ECG
timeFrame: throughout study
measure: Anti-R744 antibody titer
timeFrame: throughout study
measure: Anti-Epoetin beta antibody titer
timeFrame: throughout study
Other outcomes:
Locations:
city: Chubu
country: Japan
facility: Chubu region
city: Chugoku/Shikoku
country: Japan
facility: Chugoku/Shikoku region
city: Kanto/Koshinetsu
country: Japan
facility: Kanto/Koshinetsu region
city: Kinki/Hokuriku
country: Japan
facility: Kinki/Hokuriku region
city: Kyusyu
country: Japan
facility: Kyusyu region
Study officials:
affiliation: Chugai Pharmaceutical,Clinical Research Department 2
name: Takanori Baba
role: STUDY_CHAIR
References: