Everolimus in de Novo Kidney Transplant Recipients (NEVERWOUND)

Novartis

Status and phase: Completed; Phase 3

Conditions: Kidney Transplantation

Treatments: Drug: Cyclosporine; Drug: Everolimus; Drug: Mycophenolate sodium; Drug: Steroids

Study type: Interventional

Funder types: Industry

Identifiers

NCT01410448

2011-002866-19 (EudraCT Number)

CRAD001AIT25

Details and patient eligibility

About

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.

Enrollment: 383 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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383 participants in 2 patient groups

Immediate Everolimus (IE)

Active Comparator group

Description:

Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.

Treatment:

Drug: Steroids

Drug: Everolimus

Drug: Cyclosporine

Delayed Everolimus

Experimental group

Description:

The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.

Treatment:

Drug: Steroids

Drug: Mycophenolate sodium

Drug: Everolimus

Drug: Cyclosporine