Clinical trial NCT00433615: Clinical Study of R744 to Predialysis Patients
Official title: Switch and Maintenance Study of Subcutaneous or Intravenous Injections of R744 to Predialysis Patients ( Phase Ⅲ Study ).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia in Pre-Dialysis Patients
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2007-02-12
Enrollment: 124
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Ratio of Maintenance of target Hb concentration
timeFrame: 24th and 48th week
Secondary outcomes:
measure: Slope of regression line of Hb concentration (g/dL/week)
timeFrame: 24th week
measure: Rate of patients who maintain Hb concentration in the range of baseline ± 1.0g/dL
timeFrame: 24th week
measure: Ratio of Maintenance of Hb concentration
timeFrame: 24th and 48th week
measure: Adverse events
timeFrame: 24th and 48th week
measure: Laboratory measurements
timeFrame: 24th and 48th week
measure: Vital signs, standard 12-lead ECG
timeFrame: 24th and 48th week
measure: Anti-R744 antibody titer
timeFrame: 24th and 48th week
Other outcomes:
Locations:
city: Chubu
country: Japan
facility: Chubu region
city: Chugoku/Shikoku
country: Japan
facility: Chugoku/Shikoku region
city: Hokkaido/Tohoku
country: Japan
facility: Hokkaido/Tohoku 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: Clinical Research Department 2
name: Takanori Baba
role: STUDY_CHAIR
References: