Efficacy and Safety of the Switch From Sirolimus to Everolimus in Stable Maintenance Renal Transplant Patients Receiving a Calcineurin Inhibitor Free Regimen - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 9, 2005

Last Updated Date

February 6, 2007

Start Date ^†

February 2005

Current Primary Outcome Measures ^†

Renal function at M6 (glomerular filtration and tubular function).

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00170820 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Renal function (other tubular function parameters)
Incidence of biopsy-proven acute rejections and CMV infections
Laboratory parameters: hemoglobin, WBC, T-cell sub-populations, platelets, transaminases, total cholesterol, HDL and LDL cholesterol, apolipoproteins A1 and B, triglycerides, fasting glucose, HbA1c, LH, FSH, testosterone and TSH
Mucous and cutaneous disorders
Adverse events and serious adverse events, premature study treatment discontinuations.
Monitoring of everolimus trough levels.

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Efficacy and Safety of the Switch From Sirolimus to Everolimus in Stable Maintenance Renal Transplant Patients Receiving a Calcineurin Inhibitor Free Regimen

Official Title ^†

A Single Arm, Prospective, Open-Label, Pilot Study to Assess Effects of the Switch From Sirolimus to Everolimus in Stable Maintenance Renal Transplant Patients Receiving a Calcineurin Inhibitor Free Regimen

Brief Summary

The purpose of this study is to assess if a combination of everolimus, steroids, and mycophenolate mofetil is associated with a better renal function than sirolimus.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Renal Transplantation

Intervention ^†

Drug: Everolimus

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

First or second renal transplantation (1 to 10 years post-transplant)
Treatment with sirolimus + mycophenolate mofetil + steroids + ACE inhibitor or angiotensin II receptor antagonist + statin

Exclusion Criteria

Treatment with a CNI or azathioprine
Vascular rejection or biopsy-proven acute rejection within 3 months prior to screening
Severe dyslipidemia Other protocol-defined inclusion / exclusion criteria may apply

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Switzerland

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00170820

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Novartis

Collaborators ^††

Investigators ^†

Study Director:

Novartis

Information Provided By

Novartis

Verification Date

February 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.