Everolimus in de Novo Kidney Transplant Recipients

Kidney Transplantation Clinical Trial

— NEVERWOUND  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01410448
• Other study ID #: CRAD001AIT25
• Secondary ID: 2011-002866-19
• Status: Completed
• Phase: Phase 3
• First received: August 2, 2011
• Last updated: April 20, 2016
• Start date: November 2011
• Est. completion date: December 2015

Study information

• Verified date: October 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationItaly: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 383
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Everolimus
Immediate introduction of everolimus + low Cyclosporin + steroids
• Myfortic+ Everolimus
Delayed introduction of everolimus (delayed introduction) + low Cyclosporin + steroids

Locations

Country	Name	City	State
Italy	Novartis Investigative Site	Ancona	AN
Italy	Novartis Investigative Site	Bari	BA
Italy	Novartis Investigative Site	Bologna	BO
Italy	Novartis Investigative Site	Brescia	BS
Italy	Novartis Investigative Site	Cagliari	CA
Italy	Novartis Investigative Site	Catania	CT
Italy	Novartis Investigative Site	Coppito	AQ
Italy	Novartis Investigative Site	Firenze	FI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Modena	MO
Italy	Novartis Investigative Site	Novara
Italy	Novartis Investigative Site	Padova	PD
Italy	Novartis Investigative Site	Palermo	PA
Italy	Novartis Investigative Site	Pavia	PV
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Salerno	SA
Italy	Novartis Investigative Site	Siena	SI
Italy	Novartis Investigative Site	Verona	VR

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of wound healing complications (lymphorrhea, fluid collections, wound dehiscence, wound infections and incisional hernia).		3 months	Yes
Secondary	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		3 months	No
Secondary	Compare in the two treatment arms (immediate versus delayed everolimus administration) BPAR rate		3 Months	No
Secondary	Compare in the two treatment arms (immediate versus delayed everolimus administration) patient survival rate		3 Months	No
Secondary	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		3 Months	No
Secondary	Compare in the two treatment arms (immediate versus delayed everolimus administration) the renal function, using the estimated GFR (calculated with MDRD formula)		3 Months	No