Peritoneal Dialysis Patients Clinical Trial
Official title:
Switch and Maintenance Study of Subcutaneous or Intravenous Injections of R744 to Peritoneal Dialysis 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 Peritoneal Dialysis.
Status | Completed |
Enrollment | 72 |
Est. completion date | November 2008 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Patients who have been receiving peritoneal dialysis 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 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 <12.0 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 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 had an onset of peritonitis within 4 weeks before registration - 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 | Rate of patients who maintain Hb concentration in the range of = 10.0g/dL and = 12.0g/dL | 48 weeks | No | |
Secondary | Slope of regression line of Hb concentration (g/dL/week) | 48 weeks | No | |
Secondary | Rate of patients who maintain Hb concentration in the range of baseline ± 1.0g/dL | 48 weeks | No | |
Secondary | Rate of patients who maintain Hb concentration in the range of = 10.0g/dL and < 13.0g/dL | 48 weeks | No | |
Secondary | Laboratory measurements | 48 weeks | Yes | |
Secondary | Adverse Event | 48 weeks | Yes | |
Secondary | Anti-R744 antibody titer | 48 weeks | Yes | |
Secondary | Vital signs, standard 12-lead ECG | 48 weeks | Yes |
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