Clinical trial NCT00371826: SOCRATES: Steroid or Cyclosporine Removal After Transplantation Using Everolimus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Transplanted Recipients
Keywords: Renal transplantation
everolimus
Immunosuppressants
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-09-04
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (12 Months Analysis)
timeFrame: At Month 12
Secondary outcomes:
measure: Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (36 Months Analysis)
timeFrame: At Month 24 and 36
measure: Number of Participants With Biopsy Proven Acute Rejection (BPAR) Per Treatment Group (12 Months Analysis)
timeFrame: At Month 12
measure: Number of Participants With Biopsy Proven Acute Rejection (BPAR) Per Treatment Group (36 Months Analysis)
timeFrame: At Month 12, 24 and 36
measure: Number of Participants With Composite Endpoint of Treatment Failure (12 Months Analysis)
timeFrame: Month 12
measure: Number of Participants With Composite Endpoint of Treatment Failure (36 Months Analysis)
timeFrame: At Month 12, 24 and 36
measure: Number of Participants With Histological Evidence Chronic Allograft Nephropathy (CAN) (12 Months Analysis)
timeFrame: At Month 12
measure: Number of Participants With Histological Evidence Chronic Allograft Nephropathy (CAN) (36 Months Analysis)
timeFrame: At Month 36
measure: Number of Participants With Sub Clinical Acute Rejection (12 Months Analysis)
timeFrame: At Month 12
measure: Number of Participants With Sub Clinical Acute Rejection (36 Months Analysis)
timeFrame: At Month 36
measure: Mean Serum Creatinine (12 Months Analysis)
timeFrame: At Month 12
measure: Mean Serum Creatinine (36 Months Analysis)
timeFrame: At Month 12, 18, 24 and 36
measure: Creatinine Clearance (CrCl) Calculated by the Cockcroft-Gault Formula (12 Months Analysis)
timeFrame: At Month 12
measure: Creatinine Clearance Calculated by the Cockcroft-Gault Formula (36 Months Analysis)
timeFrame: At Month 12, 24 and 36
measure: Mean Urine Albumin/Creatinine Ratio (ACR) as Measurement of Proteinuria (12 Months Analysis)
timeFrame: At Month 12
measure: Mean Urine Albumin/Creatinine Ratio [ACR] as Measurement of Proteinuria (36 Months Analysis)
timeFrame: At Month 12, 18, 24 and 36
measure: Number of Participants With Post Transplant Diabetes Mellitus (PTDM) and Impaired Fasting Glucose (12 Months Analysis)
timeFrame: At Month 12
measure: Number of Participants With New Onset Diabetes Mellitus After Transplantation (NODAT) and Impaired Fasting Glucose (36 Months Analysis)
timeFrame: At Month 36
measure: 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)
timeFrame: Baseline, Overall post-baseline up to 12 month
measure: 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)
timeFrame: Baseline, Overall post baseline up to Month 36
measure: Number of Participants With Erythropoietin Usage (12 Months Analysis)
timeFrame: Month 12
measure: Number of Participants With Erythropoietin Usage (36 Months Analysis)
timeFrame: Month 36
measure: Mean Short-form 36 Health Survey (SF-36) Score as a Measure of Quality of Life Assessment (12 Months Analysis)
timeFrame: At Month 12
measure: Mean Short-form 36 Health Survey (SF-36) Score as a Measure of Quality of Life Assessment (36 Months Analysis)
timeFrame: At Month 24
measure: Number of Participants Hospitalized for Reasons Other Than Primary Transplantation (12 Months Analysis)
timeFrame: Month 12
measure: Number of Participants Hospitalized for Reasons Other Than Primary Transplantation (36 Months Analysis)
timeFrame: Month 36
measure: Number of Participants With Employment Status (12 Months Analysis)
timeFrame: At screening (at day 0 +/- 7 days ), At Month 12
measure: Number of Participants With Employment Status (36 Months Analysis)
timeFrame: At screening (at day 0 +/- 7 days ), At Month 36
measure: Number of Participants With Wound Problems(12 Months Analysis)
timeFrame: At Month 12
measure: Number of Participants With Any Wound Problems (36 Months Analysis)
timeFrame: At Month 12, 24 and 36
measure: Number of Participants With Notable Abnormalities in Total Cholesterol and Triglycerides as Measurement of Effect of Treatment on Cardiovascular Health (12 Months Analysis)
timeFrame: Overall post baseline up to month 12
measure: Number of Participants With Notable Abnormalities in Total Cholesterol and Triglycerides as Measurement of Effect of Treatment on Cardiovascular Health (36 Months Analysis)
timeFrame: Overall Post Baseline up to month 36
measure: Number of Participants With Antibody-mediated Rejection Per Treatment Group (12 Months Analysis)
timeFrame: At Month 12
measure: Number of Participants With Antibody-mediated Rejection Per Treatment Group (36 Months Analysis)
timeFrame: At Month 12, 24 and 36
measure: Number of Participants With Biopsy Proven Acute Rejection (BPAR) Influenced by Demographic Characteristics and Morbidities (12 Months Analysis)
timeFrame: At Month 12
measure: Number of Participants With Biopsy Proven Acute Rejection (BPAR) Influenced by Demographic Characteristics and Morbidities (36 Months Analysis)
timeFrame: At Month 36
measure: Number of Patient Survival and Graft Survival (12 Months Analysis)
timeFrame: At Month 12
measure: Number of Patient Survival and Graft Survival (36 Months Analysis)
timeFrame: At Month 12, 24 and 36
measure: Change in Bone Mineral Density Between Week 2 and Month 24 (36 Months Analysis)
timeFrame: Week 2, Month 24
Other outcomes:
Locations:
city: NSW
country: Australia
facility: Royal Prince Alfred Hospital
city: NSW
country: Australia
facility: Westmead Hospital
city: QLD
country: Australia
facility: Princess Alexandra Hospital
city: Sale
country: Australia
facility: Monash Medical Centre
city: Sale
country: Australia
facility: Queen Elizabeth Hospital
city: VIC
country: Australia
facility: Royal Melbourne Hospital
city: WA
country: Australia
facility: Sir Charles Gairdner Hospital
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References: