Predialysis Patients Clinical Trial
Official title:
Correction and Maintenance Study of Subcutaneous Injections of R744 to Predialysis Patients ( Phase III, Comparative Study in Comparison With Epoetin Beta)
| 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 used as the comparative drug (epoetin beta) will assess the efficacy and safety of subcutaneous R744 in renal anemia patients on Predialysis.
| Status | Completed |
| Enrollment | 187 |
| Est. completion date | November 2008 |
| Est. primary completion date | January 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 not receiving a rHuEPO preparation at least 16 weeks before registration - Patients whose value of Hb concentrations determined the nearest week before registration has been < 10.0 g/dL - 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 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 |
Allocation: 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 | Rate of patients who maintain mean Hb concentration in the range of = 10.0g/dL and = 12.0g/dL | 26 weeks | No | |
| Secondary | Mean Hb concentration for term of evaluation | 26 weeks | No | |
| Secondary | The ratio of patients whose Hb concentration reach = 10.0g/dL and increasing amount of Hb concentration reach = 1.0g/dL | 26 weeks | No | |
| Secondary | Time required for reaching Hb concentration of = 10.0 g/dL and reaching increasing amount of Hb concentration of = 1.0g/dL | 26 weeks | No | |
| Secondary | Slope of regression line of Hb concentration per week | 26 weeks | No | |
| Secondary | Variation of QOL | 26 weeks | No | |
| Secondary | Adverse events | 26 weeks | Yes | |
| Secondary | Laboratory measurements | 26 weeks | Yes | |
| Secondary | Vital signs, standard 12-lead ECG | 26 weeks | Yes | |
| Secondary | Anti-R744 antibody titer | 26 weeks | Yes | |
| Secondary | Anti-Epoetin beta antibody titer | 26 weeks | Yes |