Everolimus in de Novo Kidney Transplant Recipients
- Conditions
- Kidney Transplantation
- Interventions
- Registration Number
- NCT01410448
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The purpose of this study was to evaluate whether delayed (i.e. 28 ± 4 days post-transplant) administration of everolimus after transplantation reduces the risk of wound healing complications in comparison with immediate administration in de novo renal transplant patients (proportion of patients without wound/surgical complications related to initial transplant surgery) between randomization and 3 months after transplantation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 383
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Immediate Everolimus (IE) Everolimus Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months. Immediate Everolimus (IE) Cyclosporine Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months. Immediate Everolimus (IE) Steroids Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months. Delayed Everolimus Everolimus The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months. Delayed Everolimus Cyclosporine The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months. Delayed Everolimus Steroids The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months. Delayed Everolimus Mycophenolate sodium The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
- Primary Outcome Measures
Name Time Method Percentage of Participants Without Wound Healing Complications - Worst-case Scenario 3 months The percentage of participants without wound healing complications was assessed. Wound healing complications consisted of lymphorrhea, fluid collections, wound dehiscence, wound infections and incisional hernia. In the worst-case scenario, failure, i.e. at least one healing complication occurrence, was identified in one of the following cases: wound complication occurrence, missing information about wound complication occurrence, or study discontinuation due to any reason.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Serum Creatinine - Modified ITT baseline, 12 months Blood samples were collected to assess serum creatinine measurements. A negative change from baseline indicates improvement.
Percentage of Participants With Proteinuria 3 months Incidence of proteinuria (\>1,000 mg/day in urine collected in 24 hours or \> 1.0 if measured on the urine protein/creatinine concentration ratio in a spot urine sample) was assessed.
Percentage of Participants With Acute Rejection (AR) 12 months AR was defined as an episode of increased serum creatinine \>30% that was clinically diagnosed as an acute rejection but was not biopsy proven.
Percentage of Participants With a New Onset of Malignancy 12 months The percentage of participants with a new onset of malignancy was assessed.
Percentage of Participants With a New Onset of Diabetes 12 months The percentage of participants with a new onset of diabetes was assessed.
Percentage of Participants Without Wound Healing Complications - Worst-case Scenario 12 months The percentage of participants without wound healing complications was assessed. Wound healing complications consisted of lymphorrhea, fluid collections, wound dehiscence, wound infections and incisional hernia. In the worst-case scenario, failure, i.e. at least one healing complication occurrence, was identified in one of the following cases: wound complication occurrence, missing information about wound complication occurrence or study discontinuation due to any reason for participants who did not complete the 12 month follow-up visit.
Percentage of Participants Who Experienced Treatment Failure - Worst-case Scenario 3 months The percentage of participants who experienced treatment failure was assessed. Treatment failure was defined as the occurrence of at least one failure event among death, graft loss or biopsy-proven acute rejection (BPAR). In the worst-case scenario, treatment failure was identified in one of the following cases: occurrence of at least one treatment failure event or study discontinuation due to any reason.
Patient Survival Rate: Percentage of Deaths - Worst-case Scenario 3 Months, 12 months The percentage of deaths was assessed. In the worst-case scenario, failure, i.e. death, was identified in one of the following cases: participant's death or study discontinuation due to any reason.
Participant/Graft Survival Rate: Percentage of Participants With Failure Events of Death or Graft Loss - Worst-case Scenario 3 months The percentage of participants who experienced death or graft loss was assessed. In the worst-case scenario, failure, i.e. participants death or graft loss, was identified in one of the following cases: occurrence of at least one failure event or study discontinuation due to any reason.
Graft Survival Rate: Percentage of Participants With Graft Loss - Worst-case Scenario 3 months, 12 months The percentage of participants who experienced graft loss was assessed. In the worst-case scenario, failure, i.e. graft loss, was identified in one of the following cases: occurrence of graft loss or discontinuation due to any reason.
Percentage of Participants With BPAR - Worst-case Scenario 3 Months, 12 months A biopsy-proven acute rejection was defined as a biopsy graded IA, IB, IIA, IIB or III. In the worst-case scenario, failure, i.e. BPAR, was identified in one of the following cases: occurrence of BPAR or study discontinuation due to any reason.
Percentage of Participants With Delayed Graft Function (DGF) - 3 Months DGF was defined as the need for dialysis in the first week after transplant, excluding Renal Replacement Therapy within the first 24 hours after transplantation.
Duration of DGF 3 months The duration of DGF was defined as the elapsed time from first to last day of post-transplant dialysis.
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) (Calculated With Modified Diet in Renal Disease (MDRD)-4 Formula - ITT baseline, 3 Months Renal function was assessed by measuring serum creatinine and serum urea and by calculating creatinine clearance using the MDRD-4 formula. eGFR = 186.3\*(serum creatinine \[mg/dL\])\^-1.154 \* (age at screening) -0.203 \* (0.742 if female) \* (1.21 if African American). A positive change from baseline indicates improvement.
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) (Calculated With Modified Diet in Renal Disease (MDRD)-4 Formula - Modified ITT baseline, 12 months Renal function was assessed by measuring serum creatinine and serum urea and by calculating creatinine clearance using the MDRD-4 formula. eGFR = 186.3\*(serum creatinine \[mg/dL\])\^-1.154 \* (age at screening) -0.203 \* (0.742 if female) \* (1.21 if African American). A positive change from baseline indicates improvement.
Change From Baseline in Serum Creatinine - ITT baseline, 3 months Blood samples were collected to assess serum creatinine measurements. A negative change from baseline indicates improvement.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇮🇹Novara, Italy