A Phase 4 interventional study of Everolimus and Mycophenolate mofetil in Hypertrophy, Left Ventricular, sponsored by Edoardo Melilli. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-08.
Sponsored by Edoardo Melilli · Phase 4, Interventional, and Treatment
Clinical study with two parallel group to compare the efficacy of everolimus combination + tacrolimus in regression of left ventricular hypertrophy vs tacrolimus + mycophenolate mofetil in renal transplant patients in the maintenance phase.
A single-center, randomized, open-label, 12 months study, with two parallel group to compare the efficacy of everolimus combination + tacrolimus in regression of left ventricular hypertrophy vs tacrolimus + mycophenolate mofetil in renal transplant patients in the maintenance phase.
162 studies on the registry are indexed under Hypertrophy, Left Ventricular; 28 are open to participants now.
This study's enrollment of 20 is below the median of 100 across 97 interventional studies indexed under Hypertrophy, Left Ventricular.
Browse Hypertrophy, Left Ventricular studies →Edoardo Melilli is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will be converted from Tacrolimus + Mycophenolate mofetil to Everolimus + Tacrolimus 'Conversion from Mycophenolate mofetil to Everolimus'
Drug: Everolimus · Drug: Tacrolimus
Patients will remain in Tacrolimus + Mycophenolate mofetil combination
Drug: Mycophenolate mofetil · Drug: Tacrolimus
Conversion from Mycophenolate mofetil to Everolimus
Also known as: Certican
Patients will remain in Tacrolimus + Mycophenolate mofetil
Also known as: Cellcept
Also known as: Prograf
Reduction of Left Ventricular Hypertrophy
Reduction of Left Ventricular Hypertrophy more or equal than 10 g/m2 in the study group compared to control group at 12 months. Regression of LVH is defined as a decrease of 10 g/m2 compared to baseline value. Cardio nuclear magnetic resonance will be performed to evaluate left ventricular hypertrophy
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2016 to primary completion in May 2020, 42 months.
Of 14 phase 4 interventional studies under Hypertrophy, Left Ventricular, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 44. This study's 42 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Everolimus
Hypertrophy, Left Ventricular →
Edoardo Melilli