Everolimus in de Novo Kidney Transplant Recipients (NEVERWOUND)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01410448
First received: August 2, 2011
Last updated: June 3, 2014
Last verified: June 2014
  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 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)

Resource links provided by NLM:


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: 396
Study Start Date: November 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

Locations
Italy
Novartis Investigative Site Recruiting
Ancona, AN, Italy, 60126
Novartis Investigative Site Recruiting
Coppito, AQ, Italy, 67100
Novartis Investigative Site 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 Not yet recruiting
Cosenza, CS, Italy, 87100
Novartis Investigative Site Recruiting
Catania, CT, Italy, 95123
Novartis Investigative Site Recruiting
Firenze, FI, Italy, 50139
Novartis Investigative Site Recruiting
Milano, MI, Italy, 20132
Novartis Investigative Site Recruiting
Milano, MI, Italy, 20162
Novartis Investigative Site Withdrawn
Milano, MI, Italy, 20122
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 Recruiting
Roma, RM, Italy, 00161
Novartis Investigative Site Recruiting
Roma, RM, Italy, 00144
Novartis Investigative Site Withdrawn
Roma, RM, Italy, 00152
Novartis Investigative Site Recruiting
Roma, RM, Italy, 00168
Novartis Investigative Site Recruiting
Roma, RM, Italy, 00152
Novartis Investigative Site Recruiting
Salerno, SA, Italy, 84131
Novartis Investigative Site Recruiting
Siena, SI, Italy, 53100
Novartis Investigative Site Not yet recruiting
Treviso, TV, Italy, 31100
Novartis Investigative Site Withdrawn
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: June 3, 2014
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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on August 28, 2014