A Study to Evaluate the Efficacy and Safety in Kidney Transplant Recipients When Changed From Cyclosporine to Tacrolimus Prolonged-release Capsule or Tacrolimus Capsule

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Open-label, Multi-center Clinical Trial to Compare Efficacy and Safety of Cyclosporine-based and Switching Cyclosporine to Tacrolimus of Two Forms-based Immunosuppressive Therapy in Renal Transplant (KTx) Recipients

Conditions
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Kidney Transplant Recipients

Intervention / Treatment
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* Drug: Advagraf
* Drug: Prograf


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADV group<br>Once daily | Drug: Advagraf<br>* oral<br>* Other names: Tacrolimus prolonged-release capsule;|
| Experimental: PRG group<br>Twice daily | Drug: Prograf<br>* oral<br>* Other names: Tacrolimus capsule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| medication adherence | VAS will be used to evaluate adherence between PRG and ADV | Up to 52 weeks after switching | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| blood lipids | total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol and triglyceride | Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52 | 
| 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 | 
| Safety assessed by the incidence and severity of adverse events |  | Up to 52 weeks after switching | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tacrolimus, immunosuppressive therapy