Everolimus in de Novo Kidney Transplant Recipients - Full Text View

Purpose

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

Condition	Intervention	Phase
Kidney Transplantation	Drug: Everolimus Drug: Myfortic+ Everolimus	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Mycophenolic acid Mycophenolate sodium Sirolimus Mycophenolate mofetil hydrochloride Mycophenolate mofetil Everolimus Temsirolimus

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Presence of wound healing complications (lymphorrhea, fluid collections, wound dehiscence, wound infections and incisional hernia). [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]
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 ]

Estimated Enrollment:	214
Study Start Date:	November 2011
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Arm 1 Immediate introduction of everolimus + low Cyclosporin + steroids	Drug: Everolimus Immediate introduction of everolimus + low Cyclosporin + steroids
Experimental: Arm 2 Delayed introduction of everolimus (delayed introduction) + low Cyclosporin + steroids	Drug: Myfortic+ Everolimus Delayed introduction of everolimus (delayed introduction) + low Cyclosporin + steroids

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01410448

Contacts

Contact: Novartis Pharmaceuticals

41613241111

Locations

Italy
Novartis Investigative Site	Recruiting
Ancona, AN, Italy, 60126
Novartis Investigative Site	Recruiting
Coppito, AQ, Italy, 67100
Novartis Investigative Site	Not yet recruiting
Bari, BA, Italy, 70124
Novartis Investigative Site	Recruiting
Bologna, BO, Italy, 40138
Novartis Investigative Site	Recruiting
Brescia, BS, Italy, 25123
Novartis Investigative Site	Recruiting
Cagliari, CA, Italy, 09134
Novartis Investigative Site	Recruiting
Firenze, FI, Italy, 50139
Novartis Investigative Site	Withdrawn
Milano, MI, Italy, 20122
Novartis Investigative Site	Recruiting
Milano, MI, Italy, 20132
Novartis Investigative Site	Recruiting
Milano, MI, Italy, 20162
Novartis Investigative Site	Recruiting
Modena, MO, Italy, 41100
Novartis Investigative Site	Recruiting
Palermo, PA, Italy, 90127
Novartis Investigative Site	Recruiting
Padova, PD, Italy, 35128
Novartis Investigative Site	Withdrawn
Parma, PR, Italy, 43100
Novartis Investigative Site	Recruiting
Pavia, PV, Italy, 27100
Novartis Investigative Site	Recruiting
Reggio Calabria, RC, Italy, 89124
Novartis Investigative Site	Withdrawn
Roma, RM, Italy, 00152
Novartis Investigative Site	Recruiting
Roma, RM, Italy, 00168
Novartis Investigative Site	Recruiting
Roma, RM, Italy, 00161
Novartis Investigative Site	Recruiting
Roma, RM, Italy, 00152
Novartis Investigative Site	Recruiting
Roma, RM, Italy, 00144
Novartis Investigative Site	Recruiting
Salerno, SA, Italy, 84131
Novartis Investigative Site	Recruiting
Siena, SI, Italy, 53100
Novartis Investigative Site	Not yet recruiting
Vicenza, VI, Italy, 36100
Novartis Investigative Site	Recruiting
Verona, VR, Italy, 37126
Novartis Investigative Site	Withdrawn
Napoli, Italy, 80131
Novartis Investigative Site	Recruiting
Novara, Italy, 28100

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmceuticals

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01410448 History of Changes
Other Study ID Numbers:	CRAD001AIT25, 2011-002866-19
Study First Received:	August 2, 2011
Last Updated:	November 13, 2012
Health Authority:	United States: Food and Drug Administration Italy: The Italian Medicines Agency

Keywords provided by Novartis:

Immunosuppression
Kidney transplantation
everolimus
safety

Additional relevant MeSH terms:

Mycophenolate mofetil
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 19, 2013

Everolimus in de Novo Kidney Transplant Recipients (NEVERWOUND)