| May 31, 2007 |
| March 10, 2009 |
| July 2007 |
| March 2009 (final data collection date for primary outcome measure) |
| Event rate of patients with acute rejections [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ] |
| Event rate of patients with acute rejections within the first 12 weeks following transplantation. [ Time Frame: 12 weeks ] |
| Complete list of historical versions of study NCT00481819 on ClinicalTrials.gov Archive Site |
- Incidence of and time to acute rejections [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
- Overall frequency of acute rejections [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
- Rate of patient and graft survival following transplantation [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
|
| Incidence of and time to acute rejections within the first 12 weeks.
Overall frequency of acute rejections within the first 12 weeks.
Rate of patient and graft survival following transplantation |
| |
| A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Kidney Transplantation |
| A Multicenter, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Combination With MMF and Steroids in Patients Undergoing Kidney Transplantation and a Pharmacokinetics Study. |
The patients about to undergo kidney transplantation will be randomized to one of the following two group:
Group FK506MR: FK506MR/MMF/steroid; Group Prograf® : Prograf® /MMF/steroid. The treatment period is 3 months( 12 weeks) |
| |
| Phase III |
| Interventional |
| Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Kidney Transplantation |
- Drug: FK506MR
- Drug: Prograf
- Drug: Mycophenolate Mofetil
- Drug: Methylprednisolone
- Drug: Prednisolone
|
- Experimental: In combination with MMF and steroids
- Active Comparator: In combination with MMF and steroids
|
| |
| |
| Completed |
| 240 |
| March 2009 |
| March 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Written informed consent with the date of the patient must be obtained.
- Patient between 18-70 years of age receiving the primary kidney.
- Female patients must have a negative pregnancy test prior to the enrolment.
- Female patients of child bearing potential must agree to practice effective birth control during the study.
Exclusion Criteria:
- Kidney re-transplantation patients or received an organ transplantation other than a kidney.
- PRA>10% in the previous 6 months.
- Patient who need antibody induction therapy.
- Patient with significant liver disease, defined as having continuously elevated >2 times of SGPT and/or SGOT and/or total bilirubin levels during the past 28 days.
- Patient with severe infection requiring treatment, and/or severe diarrhea, vomiting, active upper gastrointestinal tract malabsorption or active peptic ulcer.
- Patient has any history of severe cardiovascular, respiratory disease; or history of malignancy.
- Patient is HIV or HBsAg positive.
- Patient is allergic to Prograf or macrolide antibiotics.
|
| Both |
| 18 Years to 70 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| China |
| |
| NCT00481819 |
| Director, Astellas Pharma, Inc |
| MR4KTxCN01 |
| Astellas Pharma Inc |
|
| Principal Investigator: |
Prof. Ao Jianhua |
Department of Urologic Surgery |
|
|
| Astellas Pharma Inc |
| March 2009 |
