NCT01269684

Brief Summary

The purpose of this study is to investigate safety and tolerability of an immediate conversion from Tacrolimus to everolimus in stable renal allograft recipients. Interest in developing CNI-free regimens using other agents such as the proliferation signal inhibitor everolimus.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
withdrawn

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

August 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 4, 2011

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

Same day

First QC Date

October 5, 2010

Last Update Submit

February 23, 2017

Conditions

Kidney Transplantation

Keywords

Kidneyrenaltransplantationtacrolimuseverolimusstable allograft recipients

Outcome Measures

Primary Outcomes (8)

  • Routine safety laboratory

    At baseline

  • Routine safety laboratory

    Week 1

  • Routine safety laboratory

    Month 1

  • Routine safety laboratory

    Week 2

  • Routine safety laboratory

    Week 3

  • Routine safety laboratory

    Month 2

  • Routine safety laboratory

    Month 4

  • Routine safety laboratory

    Month 6

Secondary Outcomes (3)

  • renal function

    At baseline

  • renal function

    Weeks 1, 2 and 3

  • renal function

    Months 1, 2, 4 and 6

Study Arms (1)

1

EXPERIMENTAL

Initial dose 1.5 mg b.i.d. Target blood trough level 4-10 ng/ml

Drug: Everolimus

Interventions

EverolimusDRUG

Initial dose 1.5 mg b.i.d. Target blood trough level 4-10 ng/ml

Also known as: Certican
1

Eligibility Criteria

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

You may qualify if:

  • Primary or secondary renal transplantation in the past 12-36 months.
  • Current immunosuppressive therapy consisting of Tacrolimus together with MMF +/-corticosteroids.
  • Moderately impaired renal function

You may not qualify if:

  • Multi-organ recipients or previous transplantation with an organ other than a kidney.
  • Acute rejection episodes in the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Zurich, Switzerland

Location

MeSH Terms

Interventions

Everolimus

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2010

First Posted

January 4, 2011

Study Start

August 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

February 24, 2017

Record last verified: 2017-02

Locations

CH(1)