Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients

Multicenter, Randomized, Open-label Trial to Evaluate the Safety, Tolerability and Efficacy of Two Regimens of Everolimus Plus Cyclosporine Microemulsion, Given According to Different Blood Target Levels, in de Novo Renal Transplant Recipients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00170885

Enrollment

Unknown

Registered

2005-09-15

Start date

2005-05-31

Completion date

2007-07-31

Last updated

2016-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Keywords

acute rejection, renal function, everolimus, cyclosporine microemulsion

Brief summary

The purpose of the study in de novo renal transplant patients is to evaluate the effect on renal function of an optimized new regimen in comparison with the standard everolimus exposure plus a low-dose cyclosporine microemulsion regimen.

Interventions

DRUGEverolimus

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Inclusion criteria

* Recipients of deceased, living unrelated, or non-human leukocyte antigen (HLA) identical living related donor renal transplant who actually have a viable kidney transplant at the time of randomization (within 24 hours of graft reperfusion) * The renal cold ischemic time must be \< 36 hours. * The age of the donor must be between 15 and 65 years.

Exclusion criteria

* Patients who are recipients of multiple organ transplants, including more than one kidney * Patients who have previously received an organ transplant which failed within one year * Patients with current panel reactive T-cell antibody titers of 50% or more * Patients who are recipients of A-B-O incompatible transplants or T-cell crossmatch positive transplant Other protocol-defined

Design outcomes

Primary

Measure	Time frame
Renal function assessed by glomerular filtration rate before and during the first 6 months of treatment	—

Secondary

Measure	Time frame
Pharmacokinetics (PK)	—
Count of CD4 and CD8 positive lymphocytes	—
Metabolic control: lipids, glycaemic control, proteinuria, enzymes	—
Ultrasound ejection fraction	—
Major adverse cardiovascular events	—

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026