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

Astellas

Status and phase

Completed

Phase 4

Conditions

Renal Transplant Recipients

Treatments

Drug: Tacrolimus sustained-release capsule

Study type

Interventional

Funder types

Industry

Identifiers

NCT02706678

BJ309CT-02

Details and patient eligibility

About

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

Enrollment

105 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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