A Phase 2/3 interventional study of Everolimus in Polycystic Kidney Diseases, sponsored by A. Manzoni Hospital. Terminated at 7 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-23.
Sponsored by A. Manzoni Hospital · Phase 2/3, Interventional, and Treatment
The study will evaluate whether the administration of everolimus (1.5 mg/day) can slow down the progression of CKD in ADPKD patients.
Considering the inhibitor activity of Everolimus on mTOR, our hypothesis is to evaluate its possible utility on the progression of CKD in ADPKD patients by reducing the rate of increase of renal cysts.
185 studies on the registry are indexed under Polycystic Kidney, Autosomal Dominant; 42 are open to participants now.
This study's enrollment of 71 is above the median of 51 across 138 interventional studies indexed under Polycystic Kidney, Autosomal Dominant.
Browse Polycystic Kidney, Autosomal Dominant studies →A. Manzoni Hospital is the lead sponsor of 5 studies on the registry; none are open to participants now.
Compared within Polycystic Kidney, Autosomal Dominant, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Polycystic Kidney Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Everolimus + standard therapy for CKD
Drug: Everolimus
Standard therapy for CKD
0.75 mg x 2 / day
Also known as: mTOR inhibitors
Reduction of GFR (according to MDRD formula) during a two-year follow up
Time frame: Two year-followup
reduction of creatinine clearance and GFR (according to Cockcroft-Gault formula) during a two-year follow up
Time frame: Two year-followup
changes in kidney size and renal and liver cysts dimensions evaluated by NMR at basal and at the end of the study
Time frame: Two year-followup
safety profile of everolimus (leucopenia, thrombocytopenia, lipid profile and other adverse events
Time frame: Two year-followup
evaluation of phosphatemia, phosphaturia and urinary cytokines on primary end point
Time frame: Two year-followup
This study is terminated, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Everolimus
Polycystic Kidney, Autosomal Dominant →
A. Manzoni Hospital