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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00170820
First Posted: September 15, 2005
Last Update Posted: February 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
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.

Condition Intervention Phase
Renal Transplantation Drug: Everolimus Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Renal function at M6 (glomerular filtration and tubular function).

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.

Estimated Enrollment: 20
Study Start Date: February 2005
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
  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): NCT00170820


Locations
Switzerland
Novartis
Basel, Switzerland
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

Additional Information:
Publications:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00170820     History of Changes
Other Study ID Numbers: CRAD001AFR04
First Submitted: September 9, 2005
First Posted: September 15, 2005
Last Update Posted: February 27, 2017
Last Verified: February 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Renal transplantation, maintenance, switch, everolimus, CNI-free

Additional relevant MeSH terms:
Everolimus
Sirolimus
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