Disorder Related to Renal TransplantationPhase 4EXETORNCT01561404
Effect of the Inhibition of the Mammalian Target of Rapamycin on Metabolism and Exercise
A Phase 4 study testing Everolimus in people with Disorder Related to Renal Transplantation and Exercise, Aerobic, run by Josep M Cruzado at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Disorder Related to Renal Transplantation, Exercise, Aerobic, Muscle Strength
- What is being tested?
- Everolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2011to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Diabetes mellitus
- Treatment with erythropoiesis stimulating drugs
- Treatment with β blockers drugs
- Participation in any clinical trial in the last 30 days prior to the inclusion.
- Any other physical illness, psychological or psychiatric condition that could difficult the follow-up of the patient.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Nephrology Department. Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelone, 08907
About this study
Official title: Effect of the Inhibition of the Mammalian Target of Rapamycin on Metabolism and Exercise.
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.
Read the detailed description
The hypothesis of the present study is that, with respect to calcineurin inhibitors, the mTOR inhibitor-based immunosuppression may alter the physical exercise capacity in renal transplant patients.
This is based on recent data obtained. Regarding metabolism there is evidence that inhibition of mTOR, reduces muscle glucose utilization, as well as, increase fatty acid oxidation. On the other hand, has shown that drugs based on mTOR inhibitors in the context of excess of nutrients improves intracellular glucose uptake in skeletal muscle cells. Through these mechanisms could increase resistance to physical exercise, which would result in an improvement in the quality of life of patients. Nevertheless, there isn't any paper that has explored this hypothesis accurately.
- Being tested
- Everolimus
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Also called m-TOR inhibitor(Everolimus)in kidney transplant recipients
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.
| Study group | Role | What they receive |
|---|---|---|
| Everolimus | Experimental | Conversion from calcineurin inhibitor (CNI) to MTOR inhibitor (everolimus) Receives: Drug: Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline to 6-8 weeks after m-TOR conversion
Secondary outcomes (6)
Anthropometric measures
Measure of anthropometric measures including height,weight, muscular folds( biceps, triceps, subscapular, pectoral, axillary, abdominal, suprailiac, thigh and leg) and perimeters (arm, forearm, wrist, abdominal, waist, hip, thigh, groin, thigh and leg).
Measured: Change from baseline to 6-8 weeks after m-TOR conversion
Strength of the hand
Measure of the strenght of the hand will include:test of maximum strength of contraction of the palm, maximum resistance force of the palm and maximum power on a cycle ergometer for 5 seconds with a constant resistance of 50 N.
Measured: Change from baseline to 6-8 weeks after m-TOR conversion
Metabolic parameters- Cardioventilatory response
Cardioventilatory response measured with respiratory rate, ventilation, oxygen consumption, carbon dioxide production, respiratory quotient and tidal volume during stress test.
Measured: Change from baseline to 6-8 weeks after m-TOR conversion
Metabolic parameters- Biochemical response
Lactate and blood glucose levels after stress test
Measured: Change from baseline to 6-8 weeks after m-TOR conversion
Glucose tolerance test
Measured: Change from baseline to 6-8 weeks after m-TOR conversion
Blood pressure
Continuos blood preassure measure (24 hours) with a holter monitor device.
Measured: Change from baseline to 6-8 weeks after m-TOR conversion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startSep 2011
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: lack of potential patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder Related to Renal TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Josep M Cruzado
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Josep M Cruzado, Hospital Universitari de Bellvitge
- Investigators
- Josep M. Cruzado, MD, Principal investigator, Nephrology Department Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561404
- Sponsor's protocol ID
- MTOR-METAB
- Other IDs
- 2009-010541-31, 2009
- Acronym
- EXETOR
- Status last verified
- Apr 2015
- First submitted
- 20 Mar 2012
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Inhibition of the Mammalian Target of Rapamycin on Metabolism and Exercise.
- ClinicalTrials.gov ID
- NCT01561404
- Acronym / sponsor ID
- EXETOR / MTOR-METAB
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of potential patients
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Josep M CruzadoUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 23 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The hypothesis of the present study is that, with respect to calcineurin inhibitors, the mTOR inhibitor-based immunosuppression may alter the physical exercise capacity in renal transplant patients.
This is based on recent data obtained. Regarding metabolism there is evidence that inhibition of mTOR, reduces muscle glucose utilization, as well as, increase fatty acid oxidation. On the other hand, has shown that drugs based on mTOR inhibitors in the context of excess of nutrients improves intracellular glucose uptake in skeletal muscle cells. Through these mechanisms could increase resistance to physical exercise, which would result in an improvement in the quality of life of patients. Nevertheless, there isn't any paper that has explored this hypothesis accurately.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Everolimus | Experimental | Drug: EverolimusConversion from calcineurin inhibitor (CNI) to MTOR inhibitor (everolimus) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (5 listed)
- Diabetes mellitus
- Treatment with erythropoiesis stimulating drugs
- Treatment with β blockers drugs
- Participation in any clinical trial in the last 30 days prior to the inclusion.
- Any other physical illness, psychological or psychiatric condition that could difficult the follow-up of the patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EverolimusAlso: m-TOR inhibitor(Everolimus)in kidney transplant recipientsIn 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. | Drug | Everolimus |
Primary outcome
Muscular strength
Time frame: Change from baseline to 6-8 weeks after m-TOR conversion
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.
Oxygen consumption in the tissues
Time frame: Change from baseline to 6-8 weeks after m-TOR conversion
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.
6 secondary outcomes
Anthropometric measures
Time frame: Change from baseline to 6-8 weeks after m-TOR conversion
Strength of the hand
Time frame: Change from baseline to 6-8 weeks after m-TOR conversion
Metabolic parameters- Cardioventilatory response
Time frame: Change from baseline to 6-8 weeks after m-TOR conversion
Metabolic parameters- Biochemical response
Time frame: Change from baseline to 6-8 weeks after m-TOR conversion
Glucose tolerance test
Time frame: Change from baseline to 6-8 weeks after m-TOR conversion
Blood pressure
Time frame: Change from baseline to 6-8 weeks after m-TOR conversion
Results and safety
The study was stopped early (reason given: lack of potential patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josep M. Cruzado, MD principal investigator
Nephrology Department Hospital Universitari de Bellvitge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Everolimus in people with Disorder Related to Renal Transplantation and Exercise, Aerobic, run by Josep M Cruzado at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of potential patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscular strength (time frame: Change from baseline to 6-8 weeks after m-TOR conversion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.