Anemia in Pre-Dialysis Patients Clinical Trial
Official title:
Switch and Maintenance Study of Subcutaneous or Intravenous Injections of R744 to Predialysis Patients ( Phase Ⅲ Study ).
| 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 |
This study will assess the efficacy and safety of subcutaneous or intravenous R744 in renal anemia patients on Predialysis.
| Status | Completed |
| Enrollment | 124 |
| Est. completion date | November 2008 |
| Est. primary completion date | November 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
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 ?), ?), ?), and whose mean value of Hb concentrations determined within 8 weeks before registration has been > 12.0 g/dL - ?)Patients with an anamnesis of myocardial infarction, pulmonary infarction or cerebral infarction (excluding asymptomatic cerebral infarction) - ?)Patients with complication of unstable angina pectoris or controlled angina pectoris (hardly controlled regardless of drug treatment or interventional treatment ) - ?)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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Chugai Pharmaceutical |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Ratio of Maintenance of target Hb concentration | 24th and 48th week | No | |
| Secondary | Slope of regression line of Hb concentration (g/dL/week) | 24th week | No | |
| Secondary | Rate of patients who maintain Hb concentration in the range of baseline ± 1.0g/dL | 24th week | No | |
| Secondary | Ratio of Maintenance of Hb concentration | 24th and 48th week | No | |
| Secondary | Adverse events | 24th and 48th week | Yes | |
| Secondary | Laboratory measurements | 24th and 48th week | Yes | |
| Secondary | Vital signs, standard 12-lead ECG | 24th and 48th week | Yes | |
| Secondary | Anti-R744 antibody titer | 24th and 48th week | Yes |