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
  Purpose

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)
  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00170885

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

No publications provided

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
everolimus
cyclosporine microemulsion

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Everolimus
Sirolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 16, 2014