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Everolimus in de Novo Kidney Transplant Recipients

NCT01410448 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 383

Last updated 2017-06-16

Study results available
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Summary

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.

Conditions

  • Kidney Transplantation

Interventions

DRUG

Everolimus

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

DRUG

Mycophenolate sodium

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.

DRUG

Cyclosporine

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

DRUG

Steroids

Steroids were administered according to local clinical practice.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01410448 on ClinicalTrials.gov