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SOCRATES: Steroid or Cyclosporine Removal After Transplantation Using Everolimus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00371826
First received: September 1, 2006
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Renal Transplanted Recipients
Drug: Everolimus (RAD001)
Drug: Cyclosporine (Calcineurin Inhibitor (CNI))
Drug: Methylprednisone/prednisone
Drug: Mycophenolate sodium (MPA)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Open-label, Controlled Multicenter Trial to Assess the Efficacy and Safety of an Induction Regimen of Cyclosporine Micro Emulsion, Enteric-coated Mycophenolate Sodium (EC-MPS) and Corticosteroids, Followed by Administration of Everolimus and Enteric-coated Mycophenolate Sodium (EC-MPS), With Either the Withdrawal of Cyclosporine Micro Emulsion or Corticosteroids in de Novo Kidney Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (12 Months Analysis) [ Time Frame: At Month 12 ] [ Designated as safety issue: No ]
    The glomerular filtration rate (GFR) was calculated by the Nankivell formula: GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)^ 2 + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients.


Secondary Outcome Measures:
  • Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (36 Months Analysis) [ Time Frame: At Month 24 and 36 ] [ Designated as safety issue: No ]
    The glomerular filtration rate (GFR) was calculated by the Nankivell formula: GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)^ 2 + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients.

  • Number of Participants With Biopsy Proven Acute Rejection (BPAR) Per Treatment Group (12 Months Analysis) [ Time Frame: At Month 12 ] [ Designated as safety issue: No ]
    A biopsy-proven acute rejection is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.

  • Number of Participants With Biopsy Proven Acute Rejection (BPAR) Per Treatment Group (36 Months Analysis) [ Time Frame: At Month 12, 24 and 36 ] [ Designated as safety issue: No ]
    A biopsy-proven acute rejection is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.

  • Number of Participants With Composite Endpoint of Treatment Failure (12 Months Analysis) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

    Composite endpoint of treatment failure includes biopsy-proven acute rejection (BPAR), graft loss, death and loss-to-follow-up. A BPAR is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.

    The allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss.


  • Number of Participants With Composite Endpoint of Treatment Failure (36 Months Analysis) [ Time Frame: At Month 12, 24 and 36 ] [ Designated as safety issue: No ]

    Composite endpoint of treatment failure includes biopsy-proven acute rejection (BPAR), graft loss, death and loss-to-follow-up. A BPAR is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.

    The allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss.


  • Number of Participants With Histological Evidence Chronic Allograft Nephropathy (CAN) (12 Months Analysis) [ Time Frame: At Month 12 ] [ Designated as safety issue: No ]

    A per-protocol biopsy was performed at Baseline and Month 12 and read by an independent blinded pathologist in order to assess chronic allograft nephropathy. Chronic rejection is characterized by a slow progressive decline in renal function and is typically preceded by the histological picture of chronic allograft nephropathy. The presence of biopsy confirmed Grade I, II or III chronic allograft nephropathy by Banff 97 criteria was assessed on all optional biopsies obtained for clinical suspicion of chronic rejection.

    Data summarized by 3 categories. "Yes" - Patients with histological evidence of CAN ; "No" - Patients with histological evidence of CAN and "Not Done" - Central protocol defined kidney allograft biopsies were not done.


  • Number of Participants With Histological Evidence Chronic Allograft Nephropathy (CAN) (36 Months Analysis) [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]

    Chronic rejection is characterized by a slow progressive decline in renal function and is typically preceded by the histological picture of chronic allograft nephropathy. The presence of biopsy confirmed Grade I, II or III chronic allograft nephropathy by Banff 97 criteria was assessed on all optional biopsies obtained for clinical suspicion of chronic rejection.

    Data summarized by 3 categories. "Yes" - Patients with histological evidence of CAN ; "No" - Patients with histological evidence of CAN and "Not Done" - Central protocol defined kidney allograft biopsies were not done.


  • Number of Participants With Sub Clinical Acute Rejection (12 Months Analysis) [ Time Frame: At Month 12 ] [ Designated as safety issue: No ]

    Based on Banff 97 criteria, sub clinical acute rejection can be:

    GRADE IA - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells).

    GRADE IB - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells).

    GRADE IIA - Cases with significant interstitial infiltration and mild to moderate intimal arteritis (v1).

    GRADE IIB - Cases with moderate to severe intimal arteritis comprising >25% of the luminal area (v2).

    GRADE III - Cases with "transmural" arteritis or fibrinoid change and necrosis of medial smooth muscle cells (v3).

    "Borderline" category is used when no intimal arteritis is present, but there are foci of mild tubulitis (1 to 4 mononuclear cells/tubular cross section).


  • Number of Participants With Sub Clinical Acute Rejection (36 Months Analysis) [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]

    Based on Banff 97 criteria, sub clinical acute rejection can be:

    GRADE IA - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells).

    GRADE IB - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells).

    GRADE IIA - Cases with significant interstitial infiltration and mild to moderate intimal arteritis (v1).

    GRADE IIB - Cases with moderate to severe intimal arteritis comprising >25% of the luminal area (v2).

    GRADE III - Cases with "transmural" arteritis or fibrinoid change and necrosis of medial smooth muscle cells (v3).

    "Borderline' category is used when no intimal arteritis is present, but there are foci of mild tubulitis (1 to 4 mononuclear cells/tubular cross section).


  • Mean Serum Creatinine (12 Months Analysis) [ Time Frame: At Month 12 ] [ Designated as safety issue: No ]
  • Mean Serum Creatinine (36 Months Analysis) [ Time Frame: At Month 12, 18, 24 and 36 ] [ Designated as safety issue: No ]
  • Creatinine Clearance (CrCl) Calculated by the Cockcroft-Gault Formula (12 Months Analysis) [ Time Frame: At Month 12 ] [ Designated as safety issue: No ]

    Creatinine clearance were calculated according to the Cockcroft-Gault formula:

    CrCl (males) = (140-A) × BW/(72 × Cr) CrCl (females) = CrCl (males) × 0.85 where A is age [years], BW is body weight [kg], and Cr is the serum concentration of creatinine [mg/dL].

    The Cockcroft-Gault formula estimates creatinine clearance based on serum creatinine level, body weight, and age.


  • Creatinine Clearance Calculated by the Cockcroft-Gault Formula (36 Months Analysis) [ Time Frame: At Month 12, 24 and 36 ] [ Designated as safety issue: No ]

    Creatinine clearance were calculated according to the Cockcroft-Gault formula:

    CrCl (males) = (140-A) × BW/(72 × Cr) CrCl (females) = CrCl (males) × 0.85 where A is age [years], BW is body weight [kg], and Cr is the serum concentration of creatinine [mg/dL].

    The Cockcroft-Gault formula estimates creatinine clearance based on serum creatinine level, body weight, and age.


  • Mean Urine Albumin/Creatinine Ratio (ACR) as Measurement of Proteinuria (12 Months Analysis) [ Time Frame: At Month 12 ] [ Designated as safety issue: No ]
    Proteinuria is measured by spot morning urine Albumin/Creatinine Ratio [ACR]. When the ACR is more than or equal to 30 mg/mmol then it is known as proteinuria.

  • Mean Urine Albumin/Creatinine Ratio [ACR] as Measurement of Proteinuria (36 Months Analysis) [ Time Frame: At Month 12, 18, 24 and 36 ] [ Designated as safety issue: No ]
    Proteinuria is measured by spot morning urine Albumin/Creatinine Ratio [ACR]. When the ACR is more than or equal to 30 mg/mmol then it is known as proteinuria.

  • Number of Participants With Post Transplant Diabetes Mellitus (PTDM) and Impaired Fasting Glucose (12 Months Analysis) [ Time Frame: At Month 12 ] [ Designated as safety issue: No ]

    The symptoms of post transplant diabetes mellitus (PTDM) and impaired fasting glucose are defined as any of the following conditions:

    1. Patients receiving glucose lowering treatment
    2. Fasting plasma glucose (FPG) >= 126 mg/dL on 2 separate occasions
    3. Hemoglobin subtype A1c (HbA1c) > 6.5%
    4. Diabetes reported as treatment emergent AE with end date > Day 15

  • Number of Participants With New Onset Diabetes Mellitus After Transplantation (NODAT) and Impaired Fasting Glucose (36 Months Analysis) [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]

    The symptoms of new onset diabetes mellitus after transplantation (NODAT) and impaired fasting glucose are defined as any of the following conditions:

    1. Patients receiving glucose lowering treatment
    2. 2 fasting plasma glucose (FPG) values >= 126 mg/dL or 2 random plasma glucose (RPG) values >= 200 mg/dL or FPG value >= 126 mg/dL and 1 RPG value >= 200 mg/dL
    3. Diabetes reported as treatment emergent AE with end date > Day 15

  • Number of Participants With Notable Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as Measurement of Effect of Treatment on Cardiovascular Health (12 Months Analysis) [ Time Frame: Baseline, Overall post-baseline up to 12 month ] [ Designated as safety issue: Yes ]

    Notable abnormal systolic blood pressure is defined as :

    • Either an increase of >=30 that results in >=180 or >200 (mm/Hg)
    • OR a decrease of >=30 that results in <=90 or <75 (mm/Hg)from baseline

    Notable abnormal diastolic blood pressure is defined as :

    • Either an increase of >=20 that results in >=105 or >115 (mm/Hg)
    • OR a decrease of >=20 that results in <=50 or <40 (mm/Hg) from baseline

  • Number of Participants With Notable Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as Measurement of Effect of Treatment on Cardiovascular Health (36 Months Analysis) [ Time Frame: Baseline, Overall post baseline up to Month 36 ] [ Designated as safety issue: Yes ]

    Notable abnormal systolic blood pressure is defined as :

    • Either an increase of >=30 that results in >=180 or >200 (mm/Hg)
    • OR a decrease of >=30 that results in <=90 or <75 (mm/Hg) from baseline

    Notable abnormal diastolic blood pressure is defined as :

    • Either an increase of >=20 that results in >=105 or >115 (mm/Hg)
    • OR a decrease of >=20 that results in <=50 or <40 (mm/Hg) from baseline

  • Number of Participants With Erythropoietin Usage (12 Months Analysis) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Number of Participants With Erythropoietin Usage (36 Months Analysis) [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
  • Mean Short-form 36 Health Survey (SF-36) Score as a Measure of Quality of Life Assessment (12 Months Analysis) [ Time Frame: At Month 12 ] [ Designated as safety issue: No ]

    SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales. The 8 subscales are: Physical functioning (PF), Role-physical (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social functioning (SF), Role-emotional (RE) and Mental health (MH).

    Score for eash sub-scale has been standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL.


  • Mean Short-form 36 Health Survey (SF-36) Score as a Measure of Quality of Life Assessment (36 Months Analysis) [ Time Frame: At Month 24 ] [ Designated as safety issue: No ]

    SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales. The 8 subscales are : Physical functioning (PF), Role-physical (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social functioning (SF), Role-emotional (RE) and Mental health (MH).

    Score for each sub-scale has been standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL.


  • Number of Participants Hospitalized for Reasons Other Than Primary Transplantation (12 Months Analysis) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    This analysis is reporting number of participants hospitalized for reasons (such as acute rejection, infection, gastrointestinal (GI) events, cardiovascular event, metabolic disorder and Other) other than primary transplantation.

  • Number of Participants Hospitalized for Reasons Other Than Primary Transplantation (36 Months Analysis) [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
    This analysis is reporting number of participants hospitalized for reasons (such as acute rejection, infection, gastrointestinal (GI) events, cardiovascular event, metabolic disorder and Other) other than primary transplantation.

  • Number of Participants With Employment Status (12 Months Analysis) [ Time Frame: At screening (at day 0 +/- 7 days ), At Month 12 ] [ Designated as safety issue: No ]

    The various employment status reported are:

    • Employed/self employed full time
    • Employed part time
    • Unemployed
    • Homemaker
    • Volunteer
    • Permanently disabled
    • Non-permanently disable
    • Retired
    • Other

  • Number of Participants With Employment Status (36 Months Analysis) [ Time Frame: At screening (at day 0 +/- 7 days ), At Month 36 ] [ Designated as safety issue: No ]

    The various employment status reported are:

    • Employed/self employed full time
    • Employed part time
    • Unemployed
    • Homemaker
    • Volunteer
    • Permanently disabled
    • Non-permanently disable
    • Retired
    • Other

  • Number of Participants With Wound Problems(12 Months Analysis) [ Time Frame: At Month 12 ] [ Designated as safety issue: No ]
    Patients with any wound healing problem such as infection related to kidney surgery, dehiscence, lymphocele, hernia, seroma, hematoma, ureteral anastomotic complication and other were reported in this analysis.

  • Number of Participants With Any Wound Problems (36 Months Analysis) [ Time Frame: At Month 12, 24 and 36 ] [ Designated as safety issue: No ]
    Patients with any wound healing problem such as infection related to kidney surgery, dehiscence, lymphocele, hernia, seroma, hematoma, ureteral anastomotic complication and other were reported in this analysis.

  • Number of Participants With Notable Abnormalities in Total Cholesterol and Triglycerides as Measurement of Effect of Treatment on Cardiovascular Health (12 Months Analysis) [ Time Frame: Overall post baseline up to month 12 ] [ Designated as safety issue: No ]

    Notable abnormal total cholesterol is defined as : High: >= 9.1 mmol/L , normal range is 0.00 - 5.17 mmol/L

    Notable abnormal triglycerides is defined as : High: >= 8.5 mmol/L, normal range is 0.30 - 2.00 mmol/L


  • Number of Participants With Notable Abnormalities in Total Cholesterol and Triglycerides as Measurement of Effect of Treatment on Cardiovascular Health (36 Months Analysis) [ Time Frame: Overall Post Baseline up to month 36 ] [ Designated as safety issue: No ]

    Notable abnormal total cholesterol is defined as : High: >= 9.1 mmol/L , normal range is 0.00 - 5.17 mmol/L

    Notable abnormal triglycerides is defined as : High: >= 8.5 mmol/L, normal range is 0.30 - 2.00 mmol/L


  • Number of Participants With Antibody-mediated Rejection Per Treatment Group (12 Months Analysis) [ Time Frame: At Month 12 ] [ Designated as safety issue: No ]
  • Number of Participants With Antibody-mediated Rejection Per Treatment Group (36 Months Analysis) [ Time Frame: At Month 12, 24 and 36 ] [ Designated as safety issue: No ]
  • Number of Participants With Biopsy Proven Acute Rejection (BPAR) Influenced by Demographic Characteristics and Morbidities (12 Months Analysis) [ Time Frame: At Month 12 ] [ Designated as safety issue: No ]
    The influence of demographic characteristics and comorbidities on incidence of BPAR were analyzed in the following way: Demographic characteristics were age (<55 years, ≥55 years), Expanded criteria Donor (ECD) organ (donor age >60 years or donor non heart-beating and donor age >50), gender, living vs. deceased donor, Body Mass Index (BMI) classes (underweight <18.5, normal 18.5 - <25.0, overweight 25.0 - <30.0, obesity 30.0 and above), years on dialysis before transplantation (<1, 1-5, >5 years). Comorbidities were diabetes, hypertension, cardiovascular diseases/events, nephrosclerosis, glomerulonephritis/glomerular disease, polycystic disease, and Cytomegalovirus status.

  • Number of Participants With Biopsy Proven Acute Rejection (BPAR) Influenced by Demographic Characteristics and Morbidities (36 Months Analysis) [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
    The influence of demographic characteristics and comorbidities on incidence of BPAR were analyzed in the following way: Demographic characteristics were age (<55 years, ≥55 years), Expanded Criteria Donor [ECD] organ (donor age >60 years or donor non heart-beating and donor age >50), gender, living vs. deceased donor, Body Mass Index (BMI) classes (underweight <18.5, normal 18.5 - <25.0, overweight 25.0 - <30.0, obesity 30.0 and above), years on dialysis before transplantation (<1, 1-5, >5 years). Comorbidities were diabetes, hypertension, cardiovascular diseases/events, nephrosclerosis, glomerulonephritis/glomerular disease, polycystic disease, and Cytomegalovirus status.

  • Number of Patient Survival and Graft Survival (12 Months Analysis) [ Time Frame: At Month 12 ] [ Designated as safety issue: No ]
  • Number of Patient Survival and Graft Survival (36 Months Analysis) [ Time Frame: At Month 12, 24 and 36 ] [ Designated as safety issue: No ]
  • Change in Bone Mineral Density Between Week 2 and Month 24 (36 Months Analysis) [ Time Frame: Week 2, Month 24 ] [ Designated as safety issue: Yes ]
    Measurements of bone mineral density (BMD) by Dual Energy X-ray Absorptiometry (DEXA) were done at Week 2 and Month 24. Change in BMD between week 2 and Month 24 were done for neck of femur and lumbar spine.


Enrollment: 126
Study Start Date: March 2006
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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

Drug: Everolimus (RAD001)
Other Name: Certican®
Drug: Cyclosporine (Calcineurin Inhibitor (CNI))
Other Name: Neoral®
Drug: Methylprednisone/prednisone Drug: Mycophenolate sodium (MPA)
Other Name: myfortic®
Experimental: 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

Drug: Everolimus (RAD001)
Other Name: Certican®
Drug: Cyclosporine (Calcineurin Inhibitor (CNI))
Other Name: Neoral®
Drug: Methylprednisone/prednisone Drug: Mycophenolate sodium (MPA)
Other Name: myfortic®
Active Comparator: 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.

Drug: Cyclosporine (Calcineurin Inhibitor (CNI))
Other Name: Neoral®
Drug: Methylprednisone/prednisone Drug: Mycophenolate sodium (MPA)
Other Name: myfortic®

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)

Other protocol-defined inclusion/exclusion criteria may applied

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371826

Locations
Australia
Royal Prince Alfred Hospital
NSW, Australia
Westmead Hospital
NSW, Australia
Princess Alexandra Hospital
QLD, Australia
Monash Medical Centre
Sale, Australia
Queen Elizabeth Hospital
Sale, Australia
Royal Melbourne Hospital
VIC, Australia
Sir Charles Gairdner Hospital
WA, Australia
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00371826     History of Changes
Other Study ID Numbers: CRAD001A2421
Study First Received: September 1, 2006
Results First Received: June 13, 2013
Last Updated: June 13, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Novartis:
Renal transplantation
everolimus
Immunosuppressants

Additional relevant MeSH terms:
Cyclosporine
Cyclosporins
Everolimus
Mycophenolate mofetil
Mycophenolic Acid
Prednisone
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014