A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Kidney Transplantation
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Transplantation
Intervention: FK506MR (Drug); Prograf (Drug); Mycophenolate Mofetil (Drug); Methylprednisolone (Drug); Prednisolone (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Prof. Ao Jianhua, Principal Investigator, Affiliation: Department of Urologic Surgery
Summary
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)
Clinical Details
Official title: 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.
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Event rate of patients with acute rejections
Secondary outcome: Incidence of and time to acute rejectionsOverall frequency of acute rejections Rate of patient and graft survival following transplantation
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
3 Sites, Beijing, China
2 Sites, Shanghai, China
Fuzhou, Fujian, China
2 Sites, Guangzhou, Guangdong, China
Wuhan, Hubei, China
Changsha, Hunan, China
Shenyang, Liaoning, China
Chongqing, Sichuan, China
Hangzhou, Zheijiang, China
Additional Information
Starting date: April 2007
Ending date: May 2008
Last updated: April 22, 2008
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