Renal Transplant Recipients
Conditions
Keywords
FK506, Renal transplant recipients, cyclosporin
Brief 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.
Interventions
DRUGTacrolimus sustained-release capsule
Oral
Sponsors
Astellas Pharma China, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in creatinine level | Baseline and Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in creatinine level | Baseline and Weeks 1, 2, 4, 8 and 12 | — |
| Incidence of rejection reaction after drug use | Up to Week 24 | — |
| Plasma concentrations of tacrolimus | Weeks 1, 2, 4, 8, 12 and 24 | — |
| Change from baseline in blood pressure | Baseline and Weeks 1, 2, 4, 8, 12 and 24 | Diastolic pressure and systolic pressure |
| Safety assessed by Adverse Events | Up to 24 weeks | — |
| Change from baseline in liver function | Baseline and Weeks 1, 2, 4, 8, 12 and 24 | Aspartate aminotransferase, alanine aminotransferase, bilirubin |
| Change from baseline in fasting blood glucose | Baseline and Weeks 1, 2, 4, 8, 12 and 24 | — |
| Change from baseline in gingival hyperplasia | Baseline and Week 24 | — |
| Change from baseline in polytrichia | Baseline and Week 24 | — |
| Change from baseline in blood lipid | Baseline and Weeks 1, 2, 4, 8, 12 and 24 | Total cholesterol, high density lipoprotein, low density lipoprotein, triglyceride |
Countries
China
Outcome results
None listed