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Sponsored by: |
Astellas Pharma Inc |
---|---|
Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00717379 |
To compare the efficacy and safety of Tacrolimus in combination with MMF and Steroids in two regimens of steroid in an adult kidney transplanted population.
Condition | Intervention | Phase |
---|---|---|
Kidney Transplantation Kidney Failure, Chronic Renal Insufficiency, Chronic |
Drug: Tacrolimus Drug: Mycophenolate Mofetil Drug: Methylprednisolone or equivalent Drug: Prednisone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Open-Label, Randomized, Multicenter, Parallel-Group Efficacy and Safety Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation |
Enrollment: | 50 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
steroid regimen 1
|
Drug: Tacrolimus
oral
Drug: Mycophenolate Mofetil
oral
Drug: Methylprednisolone or equivalent
oral
Drug: Prednisone
oral
|
2: Experimental
steroid regimen 2
|
Drug: Tacrolimus
oral
Drug: Mycophenolate Mofetil
oral
Drug: Methylprednisolone or equivalent
oral
Drug: Prednisone
oral
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Russian Federation | |
Moscow, Russian Federation, 119992 | |
St. Petersburg, Russian Federation, 197110 | |
Moscow, Russian Federation, 123182 | |
Moscow, Russian Federation, 115446 | |
Omsk, Russian Federation, 644112 | |
Volzskii, Russian Federation, 404120 |
Study Director: | Central Contact | ZAO Astellas Pharma Russia |
Responsible Party: | Astellas Pharma Europe BV ( Disclosure Office Europe ) |
Study ID Numbers: | PRG-EC-2R01 |
Study First Received: | July 16, 2008 |
Last Updated: | July 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00717379 |
Health Authority: | Russia: Ministry of Health and Social Development of the Russian Federation |
Organ Transplantation Tacrolimus Prograf Kidney Immunosuppression |
Prednisone Renal Insufficiency Methylprednisolone Kidney Failure, Chronic Methylprednisolone acetate Prednisolone acetate Tacrolimus |
Urologic Diseases Renal Insufficiency, Chronic Prednisolone Mycophenolate mofetil Kidney Diseases Methylprednisolone Hemisuccinate Kidney Failure |
Anti-Inflammatory Agents Immunologic Factors Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Antiemetics Immunosuppressive Agents |
Neuroprotective Agents Protective Agents Glucocorticoids Hormones Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |