Left Ventricular HypertrophyPhase 4NCT02493465
Effects of Everolimus in Left Ventricular Hypertrophy After Conversion From Azathioprine: A Pilot Study
A Phase 4 study testing Everolimus in people with Left Ventricular Hypertrophy, run by Instituto de Urologia e Nefrologia at 1 site in Brazil.
Trial summary
This is a prospective, open label, single-center study, in kidney transplant recipients with stable renal function for 12 and 120 months after transplantation, that are in use use of calcineurin inhibitors, azathioprine, and prednisone. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Left Ventricular Hypertrophy
- What is being tested?
- Everolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2015to Jul 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years (black and white subjects);
- Kidney transplant recipients of living donor or deceased with creatinine clearance (measured / estimated) > 50 ml /L for at least 12 months, receiving azathioprine with or without calcineurin inhibitor with or without prednisone.
Who cannot join
- The subject, in the opinion of the investigator, is not able to complete the study protocol;
- Multiple organ transplant recipient;
- Pregnant women
- Breastfeeding and childbearing age without contraceptive method
- Test for Positive immunodeficiency virus (HIV)
- Treatment of acute rejection in the last 3 months
Show all 9Show fewer
- Glomerulonephritis new relapse
- New or polyomavirus nephropathy
- protein / creatinine ≤ 150 mg / mmol or 24h proteinuria> 500mg
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto de Urologia e Nefrologia
São José do Rio Preto, São Paulo, 15015-200
Mario Abbud, MD.PhD, 551740099165, mabbud@terra.com.br
Ananda F Calori, 551740099167, estudos@iun.com.br
About this study
This is a prospective, open label, single-center study, in kidney transplant recipients with stable renal function for 12 and 120 months after transplantation, that are in use use of calcineurin inhibitors, azathioprine, and prednisone. The prevalence of left ventricular hypertrophy will be investigated before and after conversion of azathioprine to everolimus.
This study will evaluate as primary objectives: the prevalence of left ventricular mass hypertrophy in renal transplant recipients with azathioprine therapy. And assess the ability of everolimus to reduce left ventricular mass after conversion from Azathioprine, using sensitive methods such as MRI. And as secondaries objectives: Renal function (measured GFR) at 3 and 6 and 12 months after conversion, number and severity of episodes of acute rejection proven by biopsy, and the proteinuria at 3, 6 and 12 months after conversion.
- Conditions
- Left Ventricular Hypertrophy
- Being tested
- Everolimus
- Keywords
- everolimus, left ventricular hypertrophy
- Medical subject headings
- Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Conversion from azathioprine to everolimus in kidneys transplant recipients with left ventricular hypertrophy.
| Study group | Role | What they receive |
|---|---|---|
| LVH everolimus | Experimental | Progression of left ventricular hypertrophy in recipients of kidney transplant after conversion of immunossupression from azathioprine to everolimus. Receives: Drug: Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of left ventricular hypertrophy
Progression of left ventricular hypertrophy will be mesure by MIR and echocardiography (systolic and end-diastolic diameter of the left ventricle, interventricular septum thickness in end diastole, thickness of the ventricular posterior wall of the left ventricle in end-diastole, left ventricular mass, percentage of left ventricular ejection fraction.
Measured: 12 months
Secondary outcomes (3)
renal function
GFR (creatinina clearance)
Measured: 3,6, 12 months
proteinuria
24h Proteinuria
Measured: 3,6, 12 months
acute rejection episodies
clinical and biopsy if acute rejection suspected
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular HypertrophyStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Urologia e Nefrologia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARIO ABBUD FILHO, Instituto de Urologia e Nefrologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493465
- Sponsor's protocol ID
- CRAD001ABR33T
- Status last verified
- Jul 2015
- First submitted
- 6 Jul 2015
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Everolimus in Left Ventricular Hypertrophy After Conversion From Azathioprine: A Pilot Study
- ClinicalTrials.gov ID
- NCT02493465
- Acronym / sponsor ID
- CRAD001ABR33T
- Conditions
- Left Ventricular Hypertrophy
- Keywords
- everolimus, left ventricular hypertrophy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Instituto de Urologia e NefrologiaUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 9 Jul 2015 (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 a prospective, open label, single-center study, in kidney transplant recipients with stable renal function for 12 and 120 months after transplantation, that are in use use of calcineurin inhibitors, azathioprine, and prednisone. The prevalence of left ventricular hypertrophy will be investigated before and after conversion of azathioprine to everolimus.
This study will evaluate as primary objectives: the prevalence of left ventricular mass hypertrophy in renal transplant recipients with azathioprine therapy. And assess the ability of everolimus to reduce left ventricular mass after conversion from Azathioprine, using sensitive methods such as MRI. And as secondaries objectives: Renal function (measured GFR) at 3 and 6 and 12 months after conversion, number and severity of episodes of acute rejection proven by biopsy, and the proteinuria at 3, 6 and 12 months after conversion.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LVH everolimus | Experimental | Drug: EverolimusProgression of left ventricular hypertrophy in recipients of kidney transplant after conversion of immunossupression from azathioprine to everolimus. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years (black and white subjects);
- Kidney transplant recipients of living donor or deceased with creatinine clearance (measured / estimated) > 50 ml /L for at least 12 months, receiving azathioprine with or without calcineurin inhibitor with or without prednisone.
Key exclusion criteria (9 listed)
- The subject, in the opinion of the investigator, is not able to complete the study protocol;
- Multiple organ transplant recipient;
- Pregnant women
- Breastfeeding and childbearing age without contraceptive method
- Test for Positive immunodeficiency virus (HIV)
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 |
|---|---|---|
| EverolimusConversion from azathioprine to everolimus in kidneys transplant recipients with left ventricular hypertrophy. | Drug | LVH everolimus |
Primary outcome
Progression of left ventricular hypertrophy
Time frame: 12 months
Progression of left ventricular hypertrophy will be mesure by MIR and echocardiography (systolic and end-diastolic diameter of the left ventricle, interventricular septum thickness in end diastole, thickness of the ventricular posterior wall of the left ventricle in end-diastole, left ventricular mass, percentage of left ventricular ejection fraction.
3 secondary outcomes
renal function
Time frame: 3,6, 12 months
proteinuria
Time frame: 3,6, 12 months
acute rejection episodies
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 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.
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 Left Ventricular Hypertrophy, run by Instituto de Urologia e Nefrologia at 1 site in Brazil.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 9 Jul 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of left ventricular hypertrophy (time frame: 12 months). 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 9 Jul 2015.