Shift to Everolimus (RAD) Kidney Sparing Study

Safety and Efficacy of Low-dose Cyclosporine in Association With Everolimus to Minimize Renal Dysfunction in Heart Transplant Recipients

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00420537

Enrollment

Registered

2007-01-11

Start date

2006-09-30

Completion date

2009-03-31

Last updated

2010-01-12

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

Conditions

Heart Transplantation, Kidney Dysfunction

Keywords

Kidney, Heart Transplantation, Creatinine, Glomerular Filtration Rate

Brief summary

The purpose of this study is to verify if the combination of Everolimus with a very low dose of cyclosporine is more effective than the combination of mycophenolate mofetil with low-dose of cyclosporine in reducing the progression of kidney dysfunction in patients with heart transplantation.

Interventions

DRUGcyclosporine

cyclosporine trough levels between 100 and 150

DRUGMycophenolate mofetil

mycophenolate with low doses

DRUGEverolimus

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Heart Transplant with 1 to 4 years of follow-up * GFR between 20 and 60 ml/min (calculated with Colkoroft-Gault formula)

Exclusion criteria

* Acute rejection in the previous 6 months * Contraindications to statin therapy * Ongoing infection * Ongoing heart failure * Myocardial infarction or myocardial revascularization after transplant * Malignancy

Design outcomes

Primary

Measure	Time frame
Calculated GFR	One year after randomization

Countries

Italy

Outcome results

None listed

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