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

February 23, 2017 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Initial dose 1.5 mg b.i.d. Target blood trough level 4-10 ng/ml
Drug: Everolimus
Initial dose 1.5 mg b.i.d. Target blood trough level 4-10 ng/ml
Other Names:
  • Certican

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Routine safety laboratory
Time Frame: At baseline
At baseline
Routine safety laboratory
Time Frame: Week 1
Week 1
Routine safety laboratory
Time Frame: Month 1
Month 1
Routine safety laboratory
Time Frame: Week 2
Week 2
Routine safety laboratory
Time Frame: Week 3
Week 3
Routine safety laboratory
Time Frame: Month 2
Month 2
Routine safety laboratory
Time Frame: Month 4
Month 4
Routine safety laboratory
Time Frame: Month 6
Month 6

Secondary Outcome Measures

Outcome Measure
Time Frame
renal function
Time Frame: At baseline
At baseline
renal function
Time Frame: Weeks 1, 2 and 3
Weeks 1, 2 and 3
renal function
Time Frame: Months 1, 2, 4 and 6
Months 1, 2, 4 and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2008

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

October 5, 2010

First Submitted That Met QC Criteria

January 3, 2011

First Posted (Estimate)

January 4, 2011

Study Record Updates

Last Update Posted (Actual)

February 24, 2017

Last Update Submitted That Met QC Criteria

February 23, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRAD001ACH04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Kidney Transplantation

Clinical Trials on Everolimus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe