Clinical trial NCT01410448: Everolimus in de Novo Kidney Transplant Recipients
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Transplantation
Keywords: Immunosuppression
Kidney transplantation
everolimus
safety
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-08-05
Enrollment: 383
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Percentage of Participants Without Wound Healing Complications - Worst-case Scenario
timeFrame: 3 months
Secondary outcomes:
measure: Percentage of Participants Without Wound Healing Complications - Worst-case Scenario
timeFrame: 12 months
measure: Percentage of Participants Who Experienced Treatment Failure - Worst-case Scenario
timeFrame: 3 months
measure: Patient Survival Rate: Percentage of Deaths - Worst-case Scenario
timeFrame: 3 Months, 12 months
measure: Participant/Graft Survival Rate: Percentage of Participants With Failure Events of Death or Graft Loss - Worst-case Scenario
timeFrame: 3 months
measure: Graft Survival Rate: Percentage of Participants With Graft Loss - Worst-case Scenario
timeFrame: 3 months, 12 months
measure: Percentage of Participants With BPAR - Worst-case Scenario
timeFrame: 3 Months, 12 months
measure: Percentage of Participants With Delayed Graft Function (DGF) -
timeFrame: 3 Months
measure: Duration of DGF
timeFrame: 3 months
measure: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) (Calculated With Modified Diet in Renal Disease (MDRD)-4 Formula - ITT
timeFrame: baseline, 3 Months
measure: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) (Calculated With Modified Diet in Renal Disease (MDRD)-4 Formula - Modified ITT
timeFrame: baseline, 12 months
measure: Change From Baseline in Serum Creatinine - ITT
timeFrame: baseline, 3 months
measure: Change From Baseline in Serum Creatinine - Modified ITT
timeFrame: baseline, 12 months
measure: Percentage of Participants With Proteinuria
timeFrame: 3 months
measure: Percentage of Participants With Acute Rejection (AR)
timeFrame: 12 months
measure: Percentage of Participants With a New Onset of Malignancy
timeFrame: 12 months
measure: Percentage of Participants With a New Onset of Diabetes
timeFrame: 12 months
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Novartis Investigative Site
state: AN
city: Coppito
country: Italy
facility: Novartis Investigative Site
state: AQ
city: Bari
country: Italy
facility: Novartis Investigative Site
state: BA
city: Bologna
country: Italy
facility: Novartis Investigative Site
state: BO
city: Brescia
country: Italy
facility: Novartis Investigative Site
state: BS
city: Cagliari
country: Italy
facility: Novartis Investigative Site
state: CA
city: Catania
country: Italy
facility: Novartis Investigative Site
state: CT
city: Firenze
country: Italy
facility: Novartis Investigative Site
state: FI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Modena
country: Italy
facility: Novartis Investigative Site
state: MO
city: Palermo
country: Italy
facility: Novartis Investigative Site
state: PA
city: Padova
country: Italy
facility: Novartis Investigative Site
state: PD
city: Pavia
country: Italy
facility: Novartis Investigative Site
state: PV
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Salerno
country: Italy
facility: Novartis Investigative Site
state: SA
city: Siena
country: Italy
facility: Novartis Investigative Site
state: SI
city: Verona
country: Italy
facility: Novartis Investigative Site
state: VR
city: Novara
country: Italy
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: