Efficacy and Safety Study of the Switch From Cyclosporin to Tacrolimus in Renal Transplant Recipients

Efficacy and Safety of a Post-transplantation Switch From Cyclosporin to Tacrolimus Sustained-release Capsules in Renal Transplant Recipients: A Multi-center, Open-label, Uncontrolled Study

The objective of this study is to evaluate the effects of tacrolimus sustained-release capsules replacing cyclosporin on kidney function of renal transplant recipients.

Inclusion Criteria:

• 18-65 years of age, male or female
• 1-5 years after kidney transplantation
• The patient has been accepting cyclosporin-based immunosuppressive therapy for ≥6 months, and the therapeutic regimen has kept stable for at least 4 weeks before inclusion
• The dose of cyclosporin has kept stable for at least 4 weeks before inclusion
• At least one of the cyclosporin-related adverse reactions is present or the answer to the 5th question in the questionnaire is "Yes" at the time of inclusion:
• gingival hyperplasia and treatment requested by the patient
• polytrichia and interventional therapy requested by the patient
• post-transplantation hypertension
• post-transplantation hyperlipemia (total cholesterol>5.7 mmol/L (220 mg/dl))
• Serum creatinine<200 μmol/l ( 2.3 mg/dl)
• A promise is made to take contraceptive measures during the study (women at childbearing ages).

Exclusion Criteria:

• Patients having accepted transplantation of other organs apart from kidney transplantation
• Patients with 24-hour urine protein>2 g
• Patients with SGPT/ALT, SGOT/AST or total bilirubin continually increasing to more than twice the normal value(s)
• Patients with refractory infectious foci
• Patients with serious diarrhea or vomiting, active upper gastrointestinal ulcers or malabsorption
• Patients with serious heart or lung diseases or history of sugar tolerance abnormality or malignant tumors
• Patients allergic to tacrolimus or other basic medications
• Pregnant or lactating women
• Patients having participated in other clinical trials within the previous month
• Other patients who are considered by doctors unsuitable for the study