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OpenTrials
Completed

NCT Number: NCT00170820

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

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.

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Key information

Conditions

Renal Transplantation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis

Basel, Switzerland

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Everolimus

Drug

Primary outcomes

  1. Renal function at M6 (glomerular filtration and tubular function).

Secondary outcomes

  1. Renal function (other tubular function parameters)

  2. Incidence of biopsy-proven acute rejections and CMV infections

  3. 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

  4. Mucous and cutaneous disorders

  5. Adverse events and serious adverse events, premature study treatment discontinuations.

  6. Monitoring of everolimus trough levels.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
First posted
Sep 15, 2005
Registry last updated
Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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