Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been withdrawn prior to enrollment.
(No patient has never been included in the trial)
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: October 5, 2010
Last updated: February 23, 2017
Last verified: February 2017

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.

Condition Intervention Phase
Kidney Transplantation
Drug: Everolimus
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Routine safety laboratory [ Time Frame: At baseline ]
  • Routine safety laboratory [ Time Frame: Week 1 ]
  • Routine safety laboratory [ Time Frame: Month 1 ]
  • Routine safety laboratory [ Time Frame: Week 2 ]
  • Routine safety laboratory [ Time Frame: Week 3 ]
  • Routine safety laboratory [ Time Frame: Month 2 ]
  • Routine safety laboratory [ Time Frame: Month 4 ]
  • Routine safety laboratory [ Time Frame: Month 6 ]

Secondary Outcome Measures:
  • renal function [ Time Frame: At baseline ]
  • renal function [ Time Frame: Weeks 1, 2 and 3 ]
  • renal function [ Time Frame: Months 1, 2, 4 and 6 ]

Enrollment: 0
Actual Study Start Date: August 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Certican


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01269684

Novartis Investigative Site
Zurich, Switzerland
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01269684     History of Changes
Other Study ID Numbers: CRAD001ACH04
Study First Received: October 5, 2010
Last Updated: February 23, 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
stable allograft recipients

Additional relevant MeSH terms:
Calcineurin Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents processed this record on May 25, 2017