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Completed

NCT Number: NCT01410448

Everolimus in de Novo Kidney Transplant Recipients

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.

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Key information

Conditions

Kidney Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Ancona, AN, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Everolimus

Drug

Everolimus was provided in blisters containing 0.25 and 0.75 mg tablets and was taken orally.

Other names: Certican®

Mycophenolate sodium

Drug

Two 360 mg tablets were administered twice daily at 12-hour intervals. The tablets were swallowed whole in order to maintain the integrity of the enteric coating.

Other names: Myfortic®

cyclosporine

Drug

Cyclosporine was supplied as blisters containing 100 mg, 50 mg, 25 mg and 10 mg soft-gelatin capsules and was administered orally.

Other names: Neoral®

Steroids

Drug

Steroids were administered according to local clinical practice.

Primary outcomes

  1. Percentage of Participants Without Wound Healing Complications - Worst-case Scenario

    Time frame: 3 months

    The percentage of participants without wound healing complications was assessed. Wound healing complications consisted of lymphorrhea, fluid collections, wound dehiscence, wound infections and incisional hernia. In the worst-case scenario, failure, i.e. at least one healing complication occurrence, was identified in one of the following cases: wound complication occurrence, missing information about wound complication occurrence, or study discontinuation due to any reason.

Secondary outcomes

  1. Percentage of Participants Without Wound Healing Complications - Worst-case Scenario

    Time frame: 12 months

    The percentage of participants without wound healing complications was assessed. Wound healing complications consisted of lymphorrhea, fluid collections, wound dehiscence, wound infections and incisional hernia. In the worst-case scenario, failure, i.e. at least one healing complication occurrence, was identified in one of the following cases: wound complication occurrence, missing information about wound complication occurrence or study discontinuation due to any reason for participants who did not complete the 12 month follow-up visit.

  2. Percentage of Participants Who Experienced Treatment Failure - Worst-case Scenario

    Time frame: 3 months

    The percentage of participants who experienced treatment failure was assessed. Treatment failure was defined as the occurrence of at least one failure event among death, graft loss or biopsy-proven acute rejection (BPAR). In the worst-case scenario, treatment failure was identified in one of the following cases: occurrence of at least one treatment failure event or study discontinuation due to any reason.

  3. Patient Survival Rate: Percentage of Deaths - Worst-case Scenario

    Time frame: 3 Months, 12 months

    The percentage of deaths was assessed. In the worst-case scenario, failure, i.e. death, was identified in one of the following cases: participant's death or study discontinuation due to any reason.

  4. Participant/Graft Survival Rate: Percentage of Participants With Failure Events of Death or Graft Loss - Worst-case Scenario

    Time frame: 3 months

    The percentage of participants who experienced death or graft loss was assessed. In the worst-case scenario, failure, i.e. participants death or graft loss, was identified in one of the following cases: occurrence of at least one failure event or study discontinuation due to any reason.

  5. Graft Survival Rate: Percentage of Participants With Graft Loss - Worst-case Scenario

    Time frame: 3 months, 12 months

    The percentage of participants who experienced graft loss was assessed. In the worst-case scenario, failure, i.e. graft loss, was identified in one of the following cases: occurrence of graft loss or discontinuation due to any reason.

  6. Percentage of Participants With BPAR - Worst-case Scenario

    Time frame: 3 Months, 12 months

    A biopsy-proven acute rejection was defined as a biopsy graded IA, IB, IIA, IIB or III. In the worst-case scenario, failure, i.e. BPAR, was identified in one of the following cases: occurrence of BPAR or study discontinuation due to any reason.

  7. Percentage of Participants With Delayed Graft Function (DGF) -

    Time frame: 3 Months

    DGF was defined as the need for dialysis in the first week after transplant, excluding Renal Replacement Therapy within the first 24 hours after transplantation.

  8. Duration of DGF

    Time frame: 3 months

    The duration of DGF was defined as the elapsed time from first to last day of post-transplant dialysis.

  9. Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) (Calculated With Modified Diet in Renal Disease (MDRD)-4 Formula - ITT

    Time frame: baseline, 3 Months

    Renal function was assessed by measuring serum creatinine and serum urea and by calculating creatinine clearance using the MDRD-4 formula. eGFR = 186.3*(serum creatinine [mg/dL])^-1.154 * (age at screening) -0.203 * (0.742 if female) * (1.21 if African American). A positive change from baseline indicates improvement.

  10. Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) (Calculated With Modified Diet in Renal Disease (MDRD)-4 Formula - Modified ITT

    Time frame: baseline, 12 months

    Renal function was assessed by measuring serum creatinine and serum urea and by calculating creatinine clearance using the MDRD-4 formula. eGFR = 186.3*(serum creatinine [mg/dL])^-1.154 * (age at screening) -0.203 * (0.742 if female) * (1.21 if African American). A positive change from baseline indicates improvement.

  11. Change From Baseline in Serum Creatinine - ITT

    Time frame: baseline, 3 months

    Blood samples were collected to assess serum creatinine measurements. A negative change from baseline indicates improvement.

  12. Change From Baseline in Serum Creatinine - Modified ITT

    Time frame: baseline, 12 months

    Blood samples were collected to assess serum creatinine measurements. A negative change from baseline indicates improvement.

  13. Percentage of Participants With Proteinuria

    Time frame: 3 months

    Incidence of proteinuria (>1,000 mg/day in urine collected in 24 hours or > 1.0 if measured on the urine protein/creatinine concentration ratio in a spot urine sample) was assessed.

  14. Percentage of Participants With Acute Rejection (AR)

    Time frame: 12 months

    AR was defined as an episode of increased serum creatinine >30% that was clinically diagnosed as an acute rejection but was not biopsy proven.

  15. Percentage of Participants With a New Onset of Malignancy

    Time frame: 12 months

    The percentage of participants with a new onset of malignancy was assessed.

  16. Percentage of Participants With a New Onset of Diabetes

    Time frame: 12 months

    The percentage of participants with a new onset of diabetes was assessed.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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)

Acronym: NEVERWOUND

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Aug 5, 2011
Registry last updated
Jun 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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