A Study to Evaluate the Efficacy and Safety in Kidney Transplant Recipients When Changed From Cyclosporine to Tacrolimus Prolonged-release Capsule or Tacrolimus Capsule
- Registration Number
- NCT02268201
- Lead Sponsor
- Astellas Pharma China, Inc.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 17
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ADV group Advagraf Once daily PRG group Prograf Twice daily
- Primary Outcome Measures
Name Time Method medication adherence Up to 52 weeks after switching VAS will be used to evaluate adherence between PRG and ADV
- Secondary Outcome Measures
Name Time Method 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 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
liver function (AST, ALT and bilirubin) 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