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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

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

Criteria

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