Evaluation of Early Conversion to Everolimus From Cyclosporine in de Novo Renal Transplant Recipients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2013-05-31

Brief Summary

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This study is designed to evaluate if early conversion to everolimus from cyclosporine in de novo renal transplant recipients can improve long-term renal function and slow down the progression of chronic allograft nephropathy

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Detailed Description

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Conditions

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Renal Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Everolimus (CNI-free)

Patients in this group were converted to everolimus immunosuppressive therapy. The patients in the everolimus group were treated with everolimus, off-label (CNI-free) use, and EC-MPS and corticosteroids in accordance with local practice and approved label. Conversion to everolimus was as follows: Day 1: begin everolimus 3 mg in the evening. Usual morning dose of CsA and 50% reduced evening dose of CsA Day 2: everolimus 2 mg in the morning and 2 mg in the evening, complete discontinuation of CsA Day 3 or 4, and onwards: everolimus according to trough level 6-10 ng/mL.The given total daily dose of the immunosuppressive drugs (everolimus) was divided into two (equal) doses, applied 12 hours apart.

Group Type EXPERIMENTAL

everolimus

Intervention Type DRUG

Everolimus (Certican®) tablets administered orally in two divided doses (b.i.d.) at a starting dose of 4 mg/day adjusted to target a trough blood concentration between 6 and 10 ng/mL in period 2.

Enteric Coated Mycophenolate Sodium (EC-MPS)

Intervention Type DRUG

Target dose 1440 mg in the control group, target dose 1080 in the everolimus group (higher dose in the CsA group because of interactions of CsA on gastric reabsorption of mycophenolate)

corticosteroids

Intervention Type DRUG

For both groups: minimum corticosteroid dose of 10 mg until week 12, 5-10 mg until month 12, month 12-36 corticosteroid treatment on investigator's descretion.

Basiliximab

Intervention Type DRUG

Induction therapy 20 mg basiliximab on Day 0 prior to reperfusion and 20 mg on Day 4 post-TX.

Control (CsA)

Patients in the control group continued on an immunosuppressive regimen. The patients in this Control group were treated with CsA, EC-MPS and corticosteroids in accordance with local practice and approved label. The given total daily dose of the immunosuppressive drugs (CsA and EC-MPS) was divided into two (equal) doses, applied 12 hours apart.

Group Type ACTIVE_COMPARATOR

cyclosporine A

Intervention Type DRUG

CsA (Sandimmun Neoral), based on C0-h levels 75-200 ng/mL or C2-h levels 700 900 ng/mL from randomization to Month 6, or C0-h levels 50-150 ng/mL or C2-h levels 600 800 ng/mL from Month 6 to Month 36, according to local method

Enteric Coated Mycophenolate Sodium (EC-MPS)

Intervention Type DRUG

Target dose 1440 mg in the control group, target dose 1080 in the everolimus group (higher dose in the CsA group because of interactions of CsA on gastric reabsorption of mycophenolate)

corticosteroids

Intervention Type DRUG

For both groups: minimum corticosteroid dose of 10 mg until week 12, 5-10 mg until month 12, month 12-36 corticosteroid treatment on investigator's descretion.

Basiliximab

Intervention Type DRUG

Induction therapy 20 mg basiliximab on Day 0 prior to reperfusion and 20 mg on Day 4 post-TX.

Interventions

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everolimus

Everolimus (Certican®) tablets administered orally in two divided doses (b.i.d.) at a starting dose of 4 mg/day adjusted to target a trough blood concentration between 6 and 10 ng/mL in period 2.

Intervention Type DRUG

cyclosporine A

CsA (Sandimmun Neoral), based on C0-h levels 75-200 ng/mL or C2-h levels 700 900 ng/mL from randomization to Month 6, or C0-h levels 50-150 ng/mL or C2-h levels 600 800 ng/mL from Month 6 to Month 36, according to local method

Intervention Type DRUG

Enteric Coated Mycophenolate Sodium (EC-MPS)

Target dose 1440 mg in the control group, target dose 1080 in the everolimus group (higher dose in the CsA group because of interactions of CsA on gastric reabsorption of mycophenolate)

Intervention Type DRUG

corticosteroids

For both groups: minimum corticosteroid dose of 10 mg until week 12, 5-10 mg until month 12, month 12-36 corticosteroid treatment on investigator's descretion.

Intervention Type DRUG

Basiliximab

Induction therapy 20 mg basiliximab on Day 0 prior to reperfusion and 20 mg on Day 4 post-TX.

Intervention Type DRUG

Other Intervention Names

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Certican Sndimmun Neoral Myfortic Prednisolone Simulect

Eligibility Criteria

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Inclusion Criteria

* First or second single renal transplant from deceased or living donor

* Patients maintained on a triple immunosuppressive regime consisting of cyclosporine, Enteric coated mycophenolate, and corticosteroids
* Patients completed the first 7 weeks without experiencing any rejection

Exclusion Criteria

* Recipient of organs other than a renal transplant
* Present malignancy (within the last 2 years) other than excised basal cell or squamous cell carcinoma of the skin
* Severe liver disease
* At the time of randomization 7 weeks after transplantation

In addition to the above criteria the following must be met at time of randomization:

* Graft loss
* Low hemoglobin value, low number of white blood cells or platelets
* High cholesterol values
* Proteinuria
* Wound healing problems
* Current severe major local or systemic infection
* Renal insufficiency

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No