Status:
TERMINATED
A Study to Evaluate the Efficacy and Safety in Kidney Transplant Recipients When Changed From Cyclosporine to Tacrolimus Prolonged-release Capsule or Tacrolimus Capsule
Lead Sponsor:
Astellas Pharma China, Inc.
Conditions:
Kidney Transplant Recipients
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
KTx recipients receiving cyclosporine-based immunosuppressive therapy, and in the opinion of the investigator would benefit from switch to a tacrolimus-based immunosuppression, will switch the immunos...
Detailed Description
The primary objective of this study is to compare the adherence of kidney transplant recipients treated with Prograf and Advagraf regimens. The secondary objectives of this study are: * To compare t...
Eligibility Criteria
Inclusion
- Patients have received cyclosporine-based immunosuppressive therapy for more than 6 months， and have maintained a stable regimen for at least 8 weeks before enrollment
- The trough blood level of cyclosporine maintained at 50-200ng/ml at least 4 weeks before enrollment
- SCr\< 200 μmol/l ( 2.3 mg/dl)
- Females of childbearing potential must have a negative pregnancy test within 48 hrs prior to randomization and reliable methods of contraception should be started 4 weeks prior to and during the whole study
- Understand and sign the approved informed consent form
Exclusion
- Patients who have had other solid organ transplantations
- 24 hours proteinuria\>2g
- SGPT/ALT，SGOT/AST or total bilirubin rising to more than double the normal level
- Patients suffering from serious infection lesions
- Patients have severe diarrhea or vomiting, peptic ulcer and/or defective absorption
- Patients have severe heart, lung disease, abnormal glucose tolerance or malignant tumor history
- Known contraindication to administration of Tacrolimus. Subject has known hypersensitivity to tacrolimus, or any of the product excipients
- Pregnancy or lactating women
- Patients have participated in another clinical trial in the past month
- Patient refuses to sign informed consent form
- Patient not willing to continue in the study and wants to withdraw from the study
- Poor adherence or lost to follow-up
- Violation of protocol
- Severe adverse events occurred need to withdraw the study according to investigator's judgment
- Pregnancy
Key Trial Info
Start Date :
July 23 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2015
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT02268201
Start Date
July 23 2013
End Date
March 31 2015
Last Update
November 1 2024
Active Locations (7)
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1
Beijing, China
2
Fuzhou, China
3
Guangzhou, China
4
Jinan, China