Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients

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. Identifier: NCT00170885
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 16, 2016
Information provided by:

September 9, 2005
September 15, 2005
November 16, 2016
May 2005
July 2007   (Final data collection date for primary outcome measure)
Renal function assessed by glomerular filtration rate before and during the first 6 months of treatment
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Complete list of historical versions of study NCT00170885 on Archive Site
  • Pharmacokinetics (PK)
  • Count of CD4 and CD8 positive lymphocytes
  • Metabolic control: lipids, glycaemic control, proteinuria, enzymes
  • Ultrasound ejection fraction
  • Major adverse cardiovascular events
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Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients
Multicenter, Randomized, Open-label Trial to Evaluate the Safety, Tolerability and Efficacy of Two Regimens of Everolimus Plus Cyclosporine Microemulsion, Given According to Different Blood Target Levels, in de Novo Renal Transplant Recipients
The purpose of the study in de novo renal transplant patients is to evaluate the effect on renal function of an optimized new regimen in comparison with the standard everolimus exposure plus a low-dose cyclosporine microemulsion regimen.
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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Kidney Transplantation
Drug: Everolimus
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Ponticelli C, Salvadori M, Scolari MP, Citterio F, Rigotti P, Veneziano A, Bartezaghi M; EVEREST Study. Everolimus and minimization of cyclosporine in renal transplantation: 24-month follow-up of the EVEREST study. Transplantation. 2011 May 27;91(10):e72-3. doi: 10.1097/TP.0b013e318216c1db.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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July 2007
July 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Recipients of deceased, living unrelated, or non-human leukocyte antigen (HLA) identical living related donor renal transplant who actually have a viable kidney transplant at the time of randomization (within 24 hours of graft reperfusion)
  • The renal cold ischemic time must be < 36 hours.
  • The age of the donor must be between 15 and 65 years.

Exclusion Criteria:

  • Patients who are recipients of multiple organ transplants, including more than one kidney
  • Patients who have previously received an organ transplant which failed within one year
  • Patients with current panel reactive T-cell antibody titers of 50% or more
  • Patients who are recipients of A-B-O incompatible transplants or T-cell crossmatch positive transplant

Other protocol-defined exclusion criteria may apply.

Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
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Contact information is only displayed when the study is recruiting subjects
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External Affairs, Novartis Pharmaceticals
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Study Director: Novartis Novartis
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP