A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients

Study Overview
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Brief Summary
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This study evaluates two different immunosuppression drug regimens in patients with a recent kidney transplant. Patients initially received a regimen of Sirolimus, Tacrolimus and Prednisone and then randomized to discontinue either Tacrolimus or Prednisone.

Official Title
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A Randomized, Open-label and Multicenter Trial Comparing Withdrawal of Steroids or Tacrolimus From Sirolimus-based Immunosuppressive Regimen in de Novo Renal Allograft Recipients

Conditions
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Kidney Failure, Graft vs Host Disease

Intervention / Treatment
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* Drug: Tacrolimus
* Drug: Sirolimus
* Drug: prednisone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: End-stage renal disease, with patients scheduled to receive a kidney transplant. Women who are of childbearing potential who are not pregnant and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of study drugs. Any woman becoming pregnant during the treatment period must discontinue the use of study drugs; Signed informed consent. Exclusion Criteria: Evidence of active systemic or localized major infection at the time of initial study drug administration; Multiple organ transplants; Any pathology or medical condition that can interfere with this protocol study proposal. Other exclusion applies.

Ages Eligible for Study
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Minimum Age: 13 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: Sirolimus + Tacrolimus<br> | Drug: Tacrolimus<br> <br> Drug: Sirolimus<br> <br> |
| Active Comparator: Sirolimus + Prednisone<br> | Drug: Sirolimus<br> <br> Drug: prednisone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up. | Diagnosis of acute rejection was made via kidney biopsy using the Banff criteria (a standardized model for interpretation of renal allograft biopsies). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creatinine Clearance Rate | Creatinine clearance is a measure of kidney function. Creatinine clearance rate (CCr) is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, CCr was calculated using the Nakivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females, 90-125 ml/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function. | 12 months | 

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