NCT01561404

Brief Summary

This is an exploratory study based on the hypothesis that kidney transplant patients treated with an immunosuppressive therapy based on an inhibitor of the mammalian target of rapamycin (m-TOR) may increase resistance to physical exercise, which would result in an improvement in the quality of life of these patients.

Trial Health

57
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Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

September 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

2.3 years

First QC Date

March 20, 2012

Last Update Submit

April 27, 2015

Conditions

Disorder Related to Renal TransplantationExercise, AerobicMuscle Strength

Outcome Measures

Primary Outcomes (2)

  • Muscular strength

    The principal variable is the increase of the exercise capacity measured by 2 sub-varibles: muscular strenght and decrease of oxygen consumption in the tissues.

    Change from baseline to 6-8 weeks after m-TOR conversion

  • Oxygen consumption in the tissues

    The principal variable is the increase of the exercise capacity measured by 2 sub-varibles: muscular strenght and decrease of oxygen consumption in the tissues.

    Change from baseline to 6-8 weeks after m-TOR conversion

Secondary Outcomes (6)

  • Anthropometric measures

    Change from baseline to 6-8 weeks after m-TOR conversion

  • Strength of the hand

    Change from baseline to 6-8 weeks after m-TOR conversion

  • Metabolic parameters- Cardioventilatory response

    Change from baseline to 6-8 weeks after m-TOR conversion

  • Metabolic parameters- Biochemical response

    Change from baseline to 6-8 weeks after m-TOR conversion

  • Glucose tolerance test

    Change from baseline to 6-8 weeks after m-TOR conversion

  • +1 more secondary outcomes

Study Arms (1)

Everolimus

EXPERIMENTAL

Conversion from calcineurin inhibitor (CNI) to MTOR inhibitor (everolimus)

Drug: Everolimus

Interventions

EverolimusDRUG

In patients that change of immunosuppressive therapy from calcineurin inhibitor (CNI)(tacrolimus or cyclosporine) to m-TOR (everolimus)has been clinically indicated, check if there is an increase in physical exercise capacity.

Also known as: m-TOR inhibitor(Everolimus)in kidney transplant recipients
Everolimus

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Renal transplant patient's aged between 18 and 60 years old.
  • Heart rate in radial pulse and seated between 50 and 100 bpm.
  • Systolic blood pressure between 100 and 140 and diastolic between 50 to 90.
  • Absence of any clinical physical, psychological or psychiatric condition that would prevent from the protocol described follow-up.
  • Estimated glomerular filtration rate greater than 40 ml / min.
  • Proteinuria \< 0.5 g / d.
  • Renal transplantation at least 6 months ago.
  • Immunosuppressant based on calcineurin inhibitors.
  • Hemoglobin \> 11 g / dl.
  • Body mass index (BMI) \< 35 kg/m2.
  • Indication for conversion to everolimus and granting of written informed consent.

You may not qualify if:

  • Diabetes mellitus
  • Treatment with erythropoiesis stimulating drugs
  • Treatment with β blockers drugs
  • Any other physical illness, psychological or psychiatric condition that could difficult the follow-up of the patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nephrology Department. Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelone, 08907, Spain

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Josep M. Cruzado, MD

    Nephrology Department Hospital Universitari de Bellvitge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
NEPHROLOGIST

Study Record Dates

First Submitted

March 20, 2012

First Posted

March 23, 2012

Study Start

September 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations

ES(1)