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

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ClinicalTrials.gov Identifier: NCT01269684
Recruitment Status : Withdrawn (No patient has never been included in the trial)
First Posted : January 4, 2011
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Kidney Transplantation Drug: Everolimus Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : August 2008
Primary Completion Date : August 2008
Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: Certican


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01269684


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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01269684     History of Changes
Other Study ID Numbers: CRAD001ACH04
First Posted: January 4, 2011    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017

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

Additional relevant MeSH terms:
Everolimus
Sirolimus
Tacrolimus
Calcineurin Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action