NCT00154297

Brief Summary

The purpose of this study is to evaluate if the delayed administration of everolimus could reduce the everolimus associated "anti-proliferative complications" (e.g. wound healing disorder) while maintaining efficacy, when compared to the immediate administration of everolimus in de novo renal transplant patients.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

January 26, 2011

Completed
Last Updated

April 4, 2011

Status Verified

March 1, 2011

Enrollment Period

3 years

First QC Date

September 8, 2005

Results QC Date

January 4, 2011

Last Update Submit

March 30, 2011

Conditions

Renal Transplantation

Keywords

Renal transplantationeverolimusimmunosuppressantswound-healing

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months

    "In Failure", is at least one of these events occurred within the first 3 months: delayed graft function(DGF), (need for dialysis within the first 7 days,minus day one,post-transplantation); Biopsy proven acute rejection (BPAR), Graft loss, (allograft was presumed lost on the day the patient started and not removable from dialysis). Death; Loss to follow-up; Wound healing disorder(Any wound related to the kidney transplantation being opened beyond 3 weeks, or infected, or drained fluid or herniated was considered not healed).

    Month 3

Secondary Outcomes (5)

  • Number of Participants Considered in Failure for the Primary Failure Endpoint at 6 Months Post-transplantation.

    at 6 Month post-transplantation

  • Number of Participants Considered in Failure for the Primary Failure Endpoint at 12 Months Post-transplantation.

    at 12 Month post-transplantation

  • Number of Participants Who Underwent Any Dialysis Within the 12-month Treatment Period

    Month 12

  • Duration of Dialysis

    12 months

  • Number of Participants With Any Wound Healing Disorder During the 12-month Treatment Period

    Month 12

Study Arms (2)

Immediate Everolimus

ACTIVE COMPARATOR

Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.

Drug: Everolimus (RAD001)

Delayed Everolimus

EXPERIMENTAL

Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.

Drug: Everolimus (RAD001)

Interventions

Everolimus (RAD001)DRUG
Delayed EverolimusImmediate Everolimus

Eligibility Criteria

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

You may qualify if:

  • Recipients of cadaveric kidney transplants
  • Patients at risk of DGF defined as one or more of the following:
  • Donor age \> 55 years
  • Cold ischemic time (CIT) ≥ 24 hours but \< 40 hours
  • Second or subsequent renal transplantation

You may not qualify if:

  • Patients who have received an investigational drug within 4 weeks of baseline period
  • Patients who are recipients of multiple organ transplants, including more than one kidney, or previous transplant with any organ other than kidney
  • Patients with body mass index (BMI) \> 32 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

Basel, Switzerland

Location

MeSH Terms

Interventions

Everolimus

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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 8, 2005

First Posted

September 12, 2005

Study Start

June 1, 2005

Primary Completion

June 1, 2008

Last Updated

April 4, 2011

Results First Posted

January 26, 2011

Record last verified: 2011-03

Locations

CH(1)