Clinical Study of R744 to Hemodialysis Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: R744
100μg/4week for 8 weeks, then 50~250μg/4week for 16 weeks
Other Names:
Drug: rHuEPO placebo
0 IU 2 or 3 times/week for 8 weeks, then 1~3 times/week for 16 weeks
|
| Experimental: 2
|
Drug: R744
150μg/4week for 8 weeks, then 50~250μg/4week for 16 weeks
Other Names:
Drug: rHuEPO placebo
0 IU 2 or 3 times/week for 8 weeks, then 1~3 times/week for 16 weeks
|
| Active Comparator: 3
|
Drug: rHuEPO
2250IU or 3000IU(i.v.) 2 or 3 times/week for 8 weeks, then 750~9000IU(i.v.)/1~3week for 16 weeks
Drug: R744 placebo
0 μg/4week for 24 weeks
|
| Active Comparator: 4
|
Drug: rHuEPO
4500IU or 6000IU(i.v.) 2 or 3times/week for 8 weeks, then 750~9000IU(i.v.)/1~3week for 16 weeks
Drug: R744 placebo
0 μg/4week for 24 weeks
|
Outcome Measures
Primary Outcome Measures
- Variation of Hb concentration from baseline Hb concentration in evaluation period [week 17~24]
Secondary Outcome Measures
- 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 [week 17~24]
- Rate of patients who maintain Hb concentration within ±1.0g/dL of reference Hb [week 17~24]
- Adverse events [throughout study]
- Laboratory measurements [throughout study]
- Vital signs, standard 12-lead ECG [throughout study]
- Anti-R744 antibody titer [throughout study]
- Anti-Epoetin beta antibody titer [throughout study]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chubu region | Chubu | Japan | ||
| 2 | Chugoku/Shikoku region | Chugoku/Shikoku | Japan | ||
| 3 | Kanto/Koshinetsu region | Kanto/Koshinetsu | Japan | ||
| 4 | Kinki/Hokuriku region | Kinki/Hokuriku | Japan | ||
| 5 | Kyusyu region | Kyusyu | Japan |
Sponsors and Collaborators
- Chugai Pharmaceutical
Investigators
- Study Chair: Takanori Baba, Chugai Pharmaceutical,Clinical Research Department 2
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JH20876