A Study to Evaluate the Efficacy and Safety in Kidney Transplant Recipients When Changed From Cyclosporine to Tacrolimus Prolonged-release Capsule or Tacrolimus Capsule

• Status: Terminated
• Trial end date: 2015-03-31
• Target enrollment: 0
• Participant gender: All

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 immunosuppressive therapy to a tacrolimus-based one. Efficacy and safety of patients will be observed for 52 weeks.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma China, Inc.
• Treatments: Cyclosporine; Cyclosporins; Tacrolimus

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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