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:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00170820
First received: September 9, 2005
Last updated: November 1, 2011
Last verified: November 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT00170820

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00170820     History of Changes
Other Study ID Numbers: CRAD001AFR04
Study First Received: September 9, 2005
Last Updated: November 1, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on October 20, 2014