Immediate Conversion From Tacrolimus to Everolimus in Stable Maintenance Renal Transplant Recipients

A 6-Month Open Pilot Study to Investigate the Safety and Tolerability of Immediate Conversion From Calcineurin Inhibitor Tacrolimus to Everolimus in Stable Maintenance Renal Transplant Recipients

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01269684

Acronym

HERMES

Enrollment

Registered

2011-01-04

Start date

2008-08-31

Completion date

2008-08-31

Last updated

2017-02-24

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

Conditions

Kidney Transplantation

Keywords

Kidney, renal, transplantation, tacrolimus, everolimus, stable allograft recipients

Brief summary

The purpose of this study is to investigate safety and tolerability of an immediate conversion from Tacrolimus to everolimus in stable renal allograft recipients. Interest in developing CNI-free regimens using other agents such as the proliferation signal inhibitor everolimus.

Interventions

DRUGEverolimus

Initial dose 1.5 mg b.i.d. Target blood trough level 4-10 ng/ml

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Primary or secondary renal transplantation in the past 12-36 months. * Current immunosuppressive therapy consisting of Tacrolimus together with MMF +/-corticosteroids. * Moderately impaired renal function

Exclusion criteria

* Multi-organ recipients or previous transplantation with an organ other than a kidney. * Acute rejection episodes in the last 6 months. Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Routine safety laboratory	At baseline

Secondary

Measure	Time frame
renal function	At baseline

Countries

Switzerland

Outcome results

None listed

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