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

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

Official Title
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Efficacy and Safety of a Post-transplantation Switch From Cyclosporin to Tacrolimus Sustained-release Capsules in Renal Transplant Recipients: A Multi-center, Open-label, Uncontrolled Study

Conditions
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Renal Transplant Recipients

Intervention / Treatment
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* Drug: Tacrolimus sustained-release capsule


Participation Criteria
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Eligibility Criteria
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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

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tacrolimus sustained-release capsule group<br>Oral | Drug: Tacrolimus sustained-release capsule<br>* Oral<br>* Other names: FK506;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in creatinine level |  | Baseline and Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Diastolic pressure and systolic pressure | Baseline and Weeks 1, 2, 4, 8, 12 and 24 | 
| Change from baseline in blood lipid | Total cholesterol, high density lipoprotein, low density lipoprotein, triglyceride | Baseline and Weeks 1, 2, 4, 8, 12 and 24 | 
| Change from baseline in liver function | Aspartate aminotransferase, alanine aminotransferase, bilirubin | Baseline and Weeks 1, 2, 4, 8, 12 and 24 | 
| 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 | 
| Safety assessed by Adverse Events |  | Up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FK506, Renal transplant recipients, cyclosporin