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Everolimus in de Novo Kidney Transplant Recipients (NEVERWOUND)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01410448
First received: August 2, 2011
Last updated: April 3, 2017
Last verified: March 2017
August 2, 2011
April 3, 2017
November 2011
December 2015   (Final data collection date for primary outcome measure)
Percentage of Participants Without Wound Healing Complications - Worst-case Scenario [ Time Frame: 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.
Presence of wound healing complications (lymphorrea, fluid collections, wound dehiscence, wound infections and incisional hernia). [ Time Frame: 3 months ]
Complete list of historical versions of study NCT01410448 on ClinicalTrials.gov Archive Site
  • Percentage of Participants Without Wound Healing Complications - Worst-case Scenario [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) - [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: baseline, 3 months ]
    Blood samples were collected to assess serum creatinine measurements. A negative change from baseline indicates improvement.
  • Change From Baseline in Serum Creatinine - Modified ITT [ Time Frame: baseline, 12 months ]
    Blood samples were collected to assess serum creatinine measurements. A negative change from baseline indicates improvement.
  • Percentage of Participants With Proteinuria [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 12 months ]
    The percentage of participants with a new onset of malignancy was assessed.
  • Percentage of Participants With a New Onset of Diabetes [ Time Frame: 12 months ]
    The percentage of participants with a new onset of diabetes was assessed.
  • Compare in the two treatment arms (immediate versus delayed everolimus administration)treatment failure rate composite endpoint biopsy-proven acute rejection (BPAR), graft loss, death or lost to follow-up [ Time Frame: 3 months ]
  • Compare in the two treatment arms (immediate versus delayed everolimus administration) BPAR rate [ Time Frame: 3 months ]
  • Compare in the two treatment arms (immediate versus delayed everolimus administration) patient survival rate [ Time Frame: 3 Months ]
  • compare in the two treatment arms (immediate versus delayed everolimus administration) the incidence and duration (defined by the number of days requiring dialysis) of DGF [ Time Frame: 3 Months ]
  • Compare in the two treatment arms (immediate versus delayed everolimus administration) the renal function, using the estimated GFR (calculated with MDRD formula) [ Time Frame: 3 Months ]
Not Provided
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Everolimus in de Novo Kidney Transplant Recipients
A 3-month, Multicenter, Randomized, Open Label Study to Evaluate the Impact of Early Versus Delayed Introduction of Everolimus on Wound Healing in de Novo Kidney Transplant Recipients With a Follow-up Evaluation at 12 Month After Transplant (NEVERWOUND Study)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
Kidney Transplantation
  • Drug: Everolimus
    Everolimus was provided in blisters containing 0.25 and 0.75 mg tablets and was taken orally.
    Other Name: Certican®
  • Drug: Mycophenolate sodium
    Two 360 mg tablets were administered twice daily at 12-hour intervals. The tablets were swallowed whole in order to maintain the integrity of the enteric coating.
    Other Name: Myfortic®
  • Drug: Cyclosporine
    Cyclosporine was supplied as blisters containing 100 mg, 50 mg, 25 mg and 10 mg soft-gelatin capsules and was administered orally.
    Other Name: Neoral®
  • Drug: Steroids
    Steroids were administered according to local clinical practice.
  • Active Comparator: Immediate Everolimus (IE)
    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.
    Interventions:
    • Drug: Everolimus
    • Drug: Cyclosporine
    • Drug: Steroids
  • Experimental: Delayed 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.
    Interventions:
    • Drug: Everolimus
    • Drug: Mycophenolate sodium
    • Drug: Cyclosporine
    • Drug: Steroids
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
383
December 2015
December 2015   (Final data collection date for primary outcome measure)

Key Inclusion criteria:

  • Patients who are willing and able to participate in the study and who provide written informed consent before performing any study related procedure;
  • Men or women ≥18 years at transplant;
  • Recipients of 1st or 2nd single kidney transplant from deceased donor or living unrelated/related donor > 14 years;

Key Exclusion criteria:

  • Patients who are recipients of multiple organs transplant, including two kidneys;
  • Historical or current peak PRA > 50%. Patients with already existing antibodies against the donor;
  • Thrombocytopenia (platelets < 75,000/mm³), absolute neutrophil count <1,500/mm³, leucopenia (leucocytes < 2,500/mm³) or hemoglobin < 7 g/dL;
  • Body mass index (BMI) > 30 Kg/m2;
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01410448
CRAD001AIT25
2011-002866-19 ( EudraCT Number )
Not Provided
Not Provided
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Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP