NCT00170885

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started May 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

November 16, 2016

Status Verified

November 1, 2016

Enrollment Period

2.2 years

First QC Date

September 9, 2005

Last Update Submit

November 15, 2016

Conditions

Kidney Transplantation

Keywords

acute rejectionrenal functioneverolimuscyclosporine microemulsion

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

  • Pharmacokinetics (PK)

  • Count of CD4 and CD8 positive lymphocytes

  • Metabolic control: lipids, glycaemic control, proteinuria, enzymes

  • Ultrasound ejection fraction

  • Major adverse cardiovascular events

Interventions

EverolimusDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

Basel, Switzerland

Location

Related 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):e72-3. doi: 10.1097/TP.0b013e318216c1db. No abstract available.

    PMID: 21540717RESULT

MeSH Terms

Interventions

Everolimus

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

May 1, 2005

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

November 16, 2016

Record last verified: 2016-11

Locations

CH(1)