Kidney Transplant Recipients
Conditions
Keywords
tacrolimus, immunosuppressive therapy
Brief 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.
Detailed description
The primary objective of this study is to compare the adherence of kidney transplant recipients treated with Prograf and Advagraf regimens. The secondary objectives of this study are: * To compare the renal function (eGFR) in KTx recipients treated with Cyclosporine and Tacrolimus regimens. * To compare the QoL of KTx recipients treated with Cyclosporine and Tacrolimus regimens. * To compare the efficacy of Cyclosporine and Tacrolimus regimens in KTx recipients. * To compare the safety of Cyclosporine and Tacrolimus regimens in KTx recipients.
Interventions
DRUGAdvagraf
oral
DRUGPrograf
oral
Sponsors
Astellas Pharma China, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| medication adherence | Up to 52 weeks after switching | VAS will be used to evaluate adherence between PRG and ADV |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| endogenous creatinine clearance rate (Ccr) | Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52 | — |
| Calculated glomerular filtration rate | Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52 | — |
| Safety assessed by the incidence and severity of adverse events | Up to 52 weeks after switching | — |
| liver function (AST, ALT and bilirubin) | Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52 | — |
| fasting blood-glucose (FBG) | Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52 | — |
| blood lipids | Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52 | total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol and triglyceride |
Countries
China
Outcome results
None listed