A Study to Assess the Safety and Efficacy of a Tacrolimus Based Immunosuppressive Regimen in Stable Kidney Transplant Recipients Converted From Cyclosporine Based Immunosuppressive Regimen

Study Overview
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Brief Summary
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The objective of this study is to observe and evaluate the change in renal function following conversion from cyclosporine-based immunosuppressive regimen to tacrolimus-based one.

Official Title
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A Single-center Pilot Study to Assess the Safety and Efficacy of a Tacrolimus Based Immunosuppressive Regimen in Stable Kidney Transplant Recipients Converted From Cyclosporine Based Immunosuppressive Regimen

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Drug: Tacrolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients received a kidney transplant at least 12 months before enrollment. Patients whose dosage of previous immunosuppressants has not been changed and remained for at least 4 weeks before enrollment, and blood trough level of cyclosporine is 100 to 200 ng/mL. Patients who have the side effects (hypertension, hyperlipidemia, gingival hyperplasia and hypertrichosis/hirsutism) during use of cyclosporine. Serum creatinine < 2.3 mg/dl at enrollment Female patients of childbearing potential must have a negative serum pregnancy test prior to enrollment, and agreed to use effective contraception during the trial. Patients considered clinically stable Exclusion Criteria: Patients who have previously received an organ transplant other than a kidney. Patients who have had acute transplant rejection within 12 weeks, or acute transplant rejection requiring antilymphocyte therapy within 24 weeks prior to enrollment. Patients newly diagnosed malignant tumors after organ transplant, but the patients treated completely with basal or squamous cell carcinoma of the skin are excepted. Patients who have an underlying disease such as focal segmental glomerulosclerosis (FSGS) or type II membranoproliferative glomerulonephritis (Type II MPGN). Proteinuria > 2 g/24 hrs. Patients who have Creeping creatinine (a 20% increase in their creatinine for six months before their enrollment). Patients whose Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) is twice higher than the normal range in the center. Patients who have liver cirrhosis. Patients who are pregnant or breastfeeding. Patients who had been HIV-positive. Patients who have a known allergy to Prograf® or its ingredients, steroids or adjuvants. Patients who have an unstable medical condition that may affect the evaluation of the study's objectives. Patients who are receiving prohibited concomitant medications or who received those medications within 28 days of their enrollment. Patients who are currently participating in another clinical trial or who received the investigational drug in another trial within 28 days of their enrollment. Patients who are at the risk of drug abuse or mental disorders or communicate difficulties.

Ages Eligible for Study
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Minimum Age: 20 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 group<br>oral | Drug: Tacrolimus<br>* Oral<br>* Other names: Prograf (R);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in GFR | GFR: glomerular filtration rate | Baseline and Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in total cholesterol |  | Baseline and Week 24 | 
| Change from baseline in Triglycerides |  | Baseline and Week 24 | 
| Change from baseline in LDL | LDL: low density lipoprotein cholesterol | Baseline and Week 24 | 
| Change from baseline in HDL | HDL: high density lipoprotein cholesterol | Baseline and Week 24 | 
| Change from baseline in the number of antihyperlipidemic drugs |  | Baseline and Week 24 | 
| Change from baseline in blood pressure |  | Baseline and Week 24 | 
| Change from baseline in the number of antihypertensive drugs |  | Baseline and Week 24 | 
| Change from baseline in number of participants who have had hirsutism | Investigator's judgment | Baseline and Week 24 | 
| Change from baseline in number of participants who have had gingival hypertrophy | Investigator's judgment | Baseline and Week 24 | 
| Overall incidence rate of adverse events |  | up to Week 24 | 
| Proportion of participants with patient survival |  | up to Week 24 | 
| Proportion of participants with organ survival |  | up to Week 24 | 
| Acute rejection rate confirmed by biopsy |  | up to Week 24 | 
| Ratio of mean dose of cyclosporine to tacrolimus |  | up to Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tacrolimus, Kidney transplantation