Study to Evaluate Safety and Efficacy of Early Calcineurin Inhibitor Withdrawal in Primary Renal Allografts

Study Overview
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Brief Summary
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Evaluate the safety and efficacy of early corticosteroid withdrawal and simultaneous calcineurin inhibitor withdrawal in recipients of primary renal allografts maintained long-term on MMF and sirolimus.

Official Title
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Open Label Randomized Single Study to Evaluate the Safety & Efficacy of Early CNI Withdrawal in Recipients of Primary Renal Allografts Maintained Long-Term on Mycophenolate Mofetil; MMF (CellCept) and Sirolimus (Rapamune)

Conditions
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Primary Renal Allograft

Intervention / Treatment
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* Drug: mycophenolate mofetil
* Drug: sirolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients between 18 and 75 years of age. Patients who are 90 to 240 days after having received a primary living or cadaver renal allograft. Patients maintained on a regimen of cyclosporine or tacrolimus and MMF since transplantation. Capable of providing written informed consent. No known contraindications to treatment with sirolimus. Exclusion Criteria: Pregnant or lactating. Acute rejection within 90 days prior to study randomization. More than one biopsy proven acute rejection episode prior to study randomization. Previously received or are receiving an organ transplant other than kidney. Receiving sirolimus prior to entry. Severe diarrhea or other gastrointestinal disorders that may interfere with their ability to absorb oral medication. Evidence of active systemic infection requiring antibiotics, or HIV, HCV, HBV infection. History of malignancy in the past 5 years. Require dialysis at the time of study entry.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: mycophenolate mofetil|nan|
|Drug: sirolimus|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint of either acute rejection, biopsy proven calcineurin inhibitor toxicity, or failure of the estimated BSA indexed GFR by MDRD method to improve by 20% from time randomization to 12 months. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal allograft function at 6 and 12 months. |  |  | 
| Incidence of biopsy proven acute rejection at 6 and 12 months. |  |  | 
| Time to first rejection. |  |  | 
| Total number of rejection episodes per patient. |  |  | 
| Graft loss and patient death. |  |  | 
| Incidence of treatment failure. |  |  | 

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