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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00170885
First Posted: September 15, 2005
Last Update Posted: November 16, 2016
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.
Information provided by:
Novartis
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00170885


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

Additional Information:
Publications:
Responsible Party: External Affairs, Novartis Pharmaceticals
ClinicalTrials.gov Identifier: NCT00170885     History of Changes
Other Study ID Numbers: CRAD001AIT02
First Submitted: September 9, 2005
First Posted: September 15, 2005
Last Update Posted: November 16, 2016
Last Verified: November 2016

Keywords provided by Novartis:
acute rejection
renal function
everolimus
cyclosporine microemulsion

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