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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00170885
First received: September 9, 2005
Last updated: January 26, 2011
Last verified: January 2011

September 9, 2005
January 26, 2011
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
Not Provided
Complete list of historical versions of study NCT00170885 on ClinicalTrials.gov 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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Kidney Transplantation
Drug: Everolimus
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.

Both
18 Years to 75 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00170885
CRAD001AIT02
Not Provided
External Affairs, Novartis Pharmaceticals
Novartis
Not Provided
Study Director: Novartis Novartis
Novartis
January 2011

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