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

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

Condition Intervention Phase
Kidney Transplantation
Drug: Everolimus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Renal function assessed by glomerular filtration rate before and during the first 6 months of treatment

Secondary Outcome Measures:
  • Pharmacokinetics (PK)
  • Count of CD4 and CD8 positive lymphocytes
  • Metabolic control: lipids, glycaemic control, proteinuria, enzymes
  • Ultrasound ejection fraction
  • Major adverse cardiovascular events

Study Start Date: May 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both

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.

  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: NCT00170885

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

Responsible Party: External Affairs, Novartis Pharmaceticals
ClinicalTrials.gov Identifier: NCT00170885     History of Changes
Other Study ID Numbers: CRAD001AIT02 
Study First Received: September 9, 2005
Last Updated: January 26, 2011
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Novartis:
acute rejection
renal function
cyclosporine microemulsion

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Dermatologic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016