Efficacy and Safety of Early Versus Delayed Administration of Everolimus in de Novo Renal Transplant Patients

Novartis

Status and phase: Completed; Phase 4

Conditions: Renal Transplantation

Treatments: Drug: Everolimus (RAD001)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00154297

CRAD001A2420

Details and patient eligibility

About

The purpose of this study is to evaluate if the delayed administration of everolimus could reduce the everolimus associated "anti-proliferative complications" (e.g. wound healing disorder) while maintaining efficacy, when compared to the immediate administration of everolimus in de novo renal transplant patients.

Enrollment: 139 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Recipients of cadaveric kidney transplants

• Patients at risk of DGF defined as one or more of the following:

  • Donor age > 55 years
  • Cold ischemic time (CIT) ≥ 24 hours but < 40 hours
  • Second or subsequent renal transplantation

Exclusion criteria

• Patients who have received an investigational drug within 4 weeks of baseline period
• Patients who are recipients of multiple organ transplants, including more than one kidney, or previous transplant with any organ other than kidney
• Patients with body mass index (BMI) > 32 kg/m2

Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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139 participants in 2 patient groups

Immediate Everolimus

Active Comparator group

Description:

Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.

Treatment:

Drug: Everolimus (RAD001)

Delayed Everolimus

Experimental group

Description:

Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.

Treatment:

Drug: Everolimus (RAD001)