Phase 4
Completed N=126
SOCRATES: Steroid or Cyclosporine Removal After Transplantation Using Everolimus
Renal Transplanted Recipients
Source: ClinicalTrials.gov NCT00371826 ↗
Enrolled (actual)
126
Serious AEs
67.5%
Results posted
Aug 2013
Primary outcomePrimary: Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (12 Months Analysis) — 65.2; 69.3; 66.9 mL/min per 1.73 m^2
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (12 Months Analysis) |
65.2; 69.3; 66.9 | — |
| SECONDARY Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (36 Months Analysis) |
69.5; 71.8; 67.0; 71.6; 69.1; 61.0 | — |
| SECONDARY Number of Participants With Biopsy Proven Acute Rejection (BPAR) Per Treatment Group (12 Months Analysis) |
15; 6; 5 | — |
| SECONDARY Number of Participants With Biopsy Proven Acute Rejection (BPAR) Per Treatment Group (36 Months Analysis) |
4; 4; 0; 5; 5; 0 | — |
| SECONDARY Number of Participants With Composite Endpoint of Treatment Failure (12 Months Analysis) |
16; 8; 11 | — |
| SECONDARY Number of Participants With Composite Endpoint of Treatment Failure (36 Months Analysis) |
4; 4; 0; 6; 6; 0 | — |
| SECONDARY Number of Participants With Histological Evidence Chronic Allograft Nephropathy (CAN) (12 Months Analysis) |
8; 6; 2; 15; 26; 5 | — |
| SECONDARY Number of Participants With Histological Evidence Chronic Allograft Nephropathy (CAN) (36 Months Analysis) |
2; 1; 1; 8; 16; 1 | — |
| SECONDARY Number of Participants With Sub Clinical Acute Rejection (12 Months Analysis) |
20; 29; 5; 2; 2; 2 | — |
| SECONDARY Number of Participants With Sub Clinical Acute Rejection (36 Months Analysis) |
9; 15; 2; 1; 1; 0 | — |
| SECONDARY Mean Serum Creatinine (12 Months Analysis) |
118.9; 161.0; 148.6 | — |
| SECONDARY Mean Serum Creatinine (36 Months Analysis) |
112.7; 123.0; 146.8; 113.6; 121.4; 146.3 | — |
| SECONDARY Creatinine Clearance (CrCl) Calculated by the Cockcroft-Gault Formula (12 Months Analysis) |
66.1; 67.8; 63.2 | — |
| SECONDARY Creatinine Clearance Calculated by the Cockcroft-Gault Formula (36 Months Analysis) |
69.8; 71.7; 63.7; 69.9; 73.7; 66.2 | — |
| SECONDARY Mean Urine Albumin/Creatinine Ratio (ACR) as Measurement of Proteinuria (12 Months Analysis) |
0.2; 0.1; 0.1 | — |
| SECONDARY Mean Urine Albumin/Creatinine Ratio [ACR] as Measurement of Proteinuria (36 Months Analysis) |
23.5; 8.1; 4.8; 28.2; 8.1; 5.3 | — |
| SECONDARY Number of Participants With Post Transplant Diabetes Mellitus (PTDM) and Impaired Fasting Glucose (12 Months Analysis) |
10; 9; 5; 6; 0; 5 | — |
| SECONDARY Number of Participants With New Onset Diabetes Mellitus After Transplantation (NODAT) and Impaired Fasting Glucose (36 Months Analysis) |
5; 10; 2; 3; 2; 1 | — |
| SECONDARY 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) |
5; 5; 7; 1; 0; 0 | — |
| SECONDARY 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) |
3; 4; 1; 1; 0; 0 | — |
| SECONDARY Number of Participants With Erythropoietin Usage (12 Months Analysis) |
20; 10; 8 | — |
| SECONDARY Number of Participants With Erythropoietin Usage (36 Months Analysis) |
5; 7; 2 | — |
| SECONDARY Mean Short-form 36 Health Survey (SF-36) Score as a Measure of Quality of Life Assessment (12 Months Analysis) |
78.7; 76.9; 82.0; 72.9; 78.2; 100.0 | — |
| SECONDARY Mean Short-form 36 Health Survey (SF-36) Score as a Measure of Quality of Life Assessment (36 Months Analysis) |
84.3; 87.6; 90.0; 75.0; 77.4; 100.0 | — |
| SECONDARY Number of Participants Hospitalized for Reasons Other Than Primary Transplantation (12 Months Analysis) |
34; 31; 13 | — |
| SECONDARY Number of Participants Hospitalized for Reasons Other Than Primary Transplantation (36 Months Analysis) |
16; 30; 1 | — |
| SECONDARY Number of Participants With Employment Status (12 Months Analysis) |
18; 21; 9; 6; 14; 2 | — |
| SECONDARY Number of Participants With Employment Status (36 Months Analysis) |
5; 10; 1; 4; 10; 1 | — |
| SECONDARY Number of Participants With Wound Problems(12 Months Analysis) |
16; 15; 9; 2; 4; 3 | — |
| SECONDARY Number of Participants With Any Wound Problems (36 Months Analysis) |
6; 11; 2; 9; 13; 2 | — |
| SECONDARY Number of Participants With Notable Abnormalities in Total Cholesterol and Triglycerides as Measurement of Effect of Treatment on Cardiovascular Health (12 Months Analysis) |
6; 0; 3; 1; 0; 0 | — |
| SECONDARY Number of Participants With Notable Abnormalities in Total Cholesterol and Triglycerides as Measurement of Effect of Treatment on Cardiovascular Health (36 Months Analysis) |
6; 0; 1; 0; 1; 0 | — |
| SECONDARY Number of Participants With Antibody-mediated Rejection Per Treatment Group (12 Months Analysis) |
5; 2; 2 | — |
| SECONDARY Number of Participants With Antibody-mediated Rejection Per Treatment Group (36 Months Analysis) |
1; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Biopsy Proven Acute Rejection (BPAR) Influenced by Demographic Characteristics and Morbidities (12 Months Analysis) |
11; 5; 4; 4; 1; 1 | — |
| SECONDARY Number of Participants With Biopsy Proven Acute Rejection (BPAR) Influenced by Demographic Characteristics and Morbidities (36 Months Analysis) |
6; 7; 0; 0; 1; 0 | — |
| SECONDARY Number of Patient Survival and Graft Survival (12 Months Analysis) |
49; 46; 30; 49; 45; 30 | — |
| SECONDARY Number of Patient Survival and Graft Survival (36 Months Analysis) |
23; 39; 4; 23; 39; 4 | — |
| SECONDARY Change in Bone Mineral Density Between Week 2 and Month 24 (36 Months Analysis) |
0.2; -0.1; -0.1; -0.0; -0.1; -0.0 | — |
Eligibility Criteria
Inclusion criteria
- Males and females aged 18-65 years inclusive.
- First time recipients of cadaveric, living unrelated or living related donor kidney transplants.
- Patients who are willing and able to participate in the study and from whom written informed consent has been obtained.
Exclusion criteria
- 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.
- 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.
- Patients who have received an investigational drug within 4 weeks prior to the screening visit.
- 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
Data sourced from ClinicalTrials.gov (NCT00371826). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.