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

Kidney Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00170885
• Other study ID #: CRAD001AIT02
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: November 15, 2016
• Start date: May 2005
• Est. completion date: July 2007

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Everolimus

Locations

Country	Name	City	State
Switzerland	Novartis	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal function assessed by glomerular filtration rate before and during the first 6 months of treatment
Secondary	Pharmacokinetics (PK)
Secondary	Count of CD4 and CD8 positive lymphocytes
Secondary	Metabolic control: lipids, glycaemic control, proteinuria, enzymes
Secondary	Ultrasound ejection fraction
Secondary	Major adverse cardiovascular events

External Links

•   Results for CRAD001AIT02 from the Novartis Clinical Trials website