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

This study has suspended participant recruitment.
(No patient has never been included in the trial)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01269684
First received: October 5, 2010
Last updated: November 1, 2011
Last verified: November 2011
History of Changes
  Purpose

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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
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:

U.S. FDA Resources

Further study details as provided by Novartis:

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

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

Estimated Enrollment: 15
Study Start Date: August 2008
Primary Completion Date: June 2009 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269684

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01269684     History of Changes
Other Study ID Numbers: CRAD001ACH04
Study First Received: October 5, 2010
Last Updated: November 1, 2011
Health Authority: Switzerland: Swissmedic

Keywords provided by Novartis:
Kidney
renal
transplantation
 tacrolimus
everolimus
stable allograft recipients

Additional relevant MeSH terms:
Everolimus
Sirolimus
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
 Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 16, 2013