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SOCRATES: Steroid or Cyclosporine Removal After Transplantation Using Everolimus

NCT ID: NCT00371826

Last Updated: 2013-08-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2012-06-30

Brief Summary

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The aim of this study is to assess the safety and efficacy of corticosteroid discontinuation versus cyclosporine micro emulsion discontinuation in recipients receiving reduced exposure cyclosporine micro emulsion and corticosteroids plus enteric-coated mycophenolate sodium (EC-MPS) initially, changed to everolimus at 2 weeks post-transplant. These two groups will be compared to a third control group, who will receive treatment consisting of cyclosporine micro emulsion, enteric-coated mycophenolate sodium (EC-MPS) and steroids.

Detailed Description

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Conditions

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Renal Transplanted Recipients

Keywords

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Renal transplantation everolimus Immunosuppressants

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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Calcineurin Inhibitor (CNI) Withdrawal

Every randomized patient in this group received

Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone

Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough \>6 ng/mL, then MPA was stopped + prednisone 10-30mg/day

Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day

Group Type EXPERIMENTAL

Everolimus (RAD001)

Intervention Type DRUG

Cyclosporine (Calcineurin Inhibitor (CNI))

Intervention Type DRUG

Methylprednisone/prednisone

Intervention Type DRUG

Mycophenolate sodium (MPA)

Intervention Type DRUG

Steroid Withdrawal

Every randomized patient in this group received

Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day

Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough \>6 ng/mL, then MPA was stopped + prednisone 10-30mg per day

Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.

Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol

Group Type EXPERIMENTAL

Everolimus (RAD001)

Intervention Type DRUG

Cyclosporine (Calcineurin Inhibitor (CNI))

Intervention Type DRUG

Methylprednisone/prednisone

Intervention Type DRUG

Mycophenolate sodium (MPA)

Intervention Type DRUG

CNI+MPA+ Steroid

Patients randomized to this group received:

Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.

Group Type ACTIVE_COMPARATOR

Cyclosporine (Calcineurin Inhibitor (CNI))

Intervention Type DRUG

Methylprednisone/prednisone

Intervention Type DRUG

Mycophenolate sodium (MPA)

Intervention Type DRUG

Interventions

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Everolimus (RAD001)

Intervention Type DRUG

Cyclosporine (Calcineurin Inhibitor (CNI))

Intervention Type DRUG

Methylprednisone/prednisone

Intervention Type DRUG

Mycophenolate sodium (MPA)

Intervention Type DRUG

Other Intervention Names

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Certican® Neoral® myfortic®

Eligibility Criteria

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Inclusion Criteria

1. Males and females aged 18-65 years inclusive.
2. First time recipients of cadaveric, living unrelated or living related donor kidney transplants.
3. Patients who are willing and able to participate in the study and from whom written informed consent has been obtained.

Exclusion Criteria

1. Patients who are recipients of multiple organ transplants, including more than one kidney, kidney and pancreas, or previous transplant with any organ other than kidney.
2. Patients at high immunological risk of graft loss, indicated by peak PRA \>50% or loss of a previous renal allograft within the first 6 months of transplantation due to acute rejection.
3. Patients who have received an investigational drug within 4 weeks prior to the screening visit.
4. Presence of any severe allergy or hypersensitivity to drugs similar to everolimus (e.g. antibiotics such as Clindamycin)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis

Role: STUDY_DIRECTOR

Novartis

Locations

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Royal Prince Alfred Hospital

NSW, , Australia

Site Status

Westmead Hospital

NSW, , Australia

Site Status

Princess Alexandra Hospital

QLD, , Australia

Site Status

Monash Medical Centre

Sale, , Australia

Site Status

Queen Elizabeth Hospital

Sale, , Australia

Site Status

Royal Melbourne Hospital

VIC, , Australia

Site Status

Sir Charles Gairdner Hospital

WA, , Australia

Site Status

Countries

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Australia

Other Identifiers

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CRAD001A2421

Identifier Type: -

Identifier Source: org_study_id