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Sponsored by: |
Chugai Pharmaceutical |
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Information provided by: | Chugai Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT00433849 |
This study will assess the efficacy and safety of subcutaneous or intravenous R744 in renal anemia patients on Peritoneal Dialysis.
Condition | Intervention | Phase |
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Peritoneal Dialysis Patients |
Drug: R744 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Switch and Maintenance Study of Subcutaneous or Intravenous Injections of R744 to Peritoneal Dialysis Patients (Phase Ⅲ Study) |
Enrollment: | 72 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | October 2008 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: R744
100μg(i.v./p.o.)/4weeks for 8 weeks, then 25~400μg(i.v./p.o.)/4weeks for 40 weeks
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2: Experimental |
Drug: R744
150μg(i.v./p.o.)/4weeks for 8 weeks, then 25~400μg(i.v./p.o.)/4weeks for 40 weeks
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Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan | |
Hokkaido/Tohoku region | |
Hokkaido/Tohoku, Japan | |
Kanto/Koshinetsu region | |
Kanto/Koshinetsu, Japan | |
Chubu region | |
Chubu, Japan | |
Kyusyu region | |
Kyusyu, Japan | |
Chugoku/Shikoku region | |
Chugoku/Shikoku, Japan | |
Kinki/Hokuriku region | |
Kinki/Hokuriku, Japan |
Study Chair: | Takanori Baba | Clinical Research Department 2 |
Responsible Party: | Chugai Pharmaceutical ( Chugai Pharmaceutical ) |
Study ID Numbers: | JH20564 |
Study First Received: | February 8, 2007 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00433849 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |