Everolimus in de Novo Kidney Transplant Recipients (NEVERWOUND)

This study is currently recruiting participants.
Verified October 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01410448
First received: August 2, 2011
Last updated: October 12, 2013
Last verified: October 2013

August 2, 2011
October 12, 2013
November 2011
July 2015   (final data collection date for primary outcome measure)
Presence of wound healing complications (lymphorrhea, fluid collections, wound dehiscence, wound infections and incisional hernia). [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Presence of wound healing complications (lymphorrea, fluid collections, wound dehiscence, wound infections and incisional hernia). [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01410448 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Compare in the two treatment arms (immediate versus delayed everolimus administration) BPAR rate [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  • Compare in the two treatment arms (immediate versus delayed everolimus administration) patient survival rate [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Everolimus in de Novo Kidney Transplant Recipients
A 3-month, Multicenter, Randomized, Open Label Study to Evaluate the Impact of Early vs Delayed Introduction of Everolimus on Wound Healing in de Novo Kidney Transplant Recipients (NEVERWOUND Study)

The purpose of this study is 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: Open Label
Primary Purpose: Prevention
Kidney Transplantation
  • Drug: Everolimus
    Immediate introduction of everolimus + low Cyclosporin + steroids
  • Drug: Myfortic+ Everolimus
    Delayed introduction of everolimus (delayed introduction) + low Cyclosporin + steroids
  • Active Comparator: Arm 1
    Immediate introduction of everolimus + low Cyclosporin + steroids
    Intervention: Drug: Everolimus
  • Experimental: Arm 2
    Delayed introduction of everolimus (delayed introduction) + low Cyclosporin + steroids
    Intervention: Drug: Myfortic+ Everolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
214
July 2015
July 2015   (final data collection date for primary outcome measure)

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;

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;

Other protocol-defined inclusion/exclusion criteria may apply

Both
18 Years and older
No
Contact: Novartis Pharmaceuticals 41613241111
Italy
 
NCT01410448
CRAD001AIT25, 2011-002866-19
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmceuticals Novartis Pharmaceuticals
Novartis
October 2013

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