Polycystic Kidney DiseasesPhase 2/3NCT01009957
Everolimus on CKD Progression in ADPKD Patients
A Phase 2/3 study testing Everolimus in people with Polycystic Kidney Diseases, run by A. Manzoni Hospital at 7 sites in Italy.
Trial summary
The study will evaluate whether the administration of everolimus (1.5 mg/day) can slow down the progression of CKD in ADPKD patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polycystic Kidney Diseases
- What is being tested?
- Everolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 7 sitesItaly
- Study dates
- Jun 2008to Jun 2015
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects over 18 years of both genders
- Clinical diagnosis of autosomal dominant polycystic kidney disease (ADPKD)
- GFR, according to MDRD formula, between 30 and 90 ml/min/1.73 mq
- Previous follow up of two years, with a creatinine evaluation at least once a year
- GFR reduction of at least 2.5 ml/min/year (according to MDRD formula)
Who cannot join
- Pregnancy, lactating, males and females without adequate contraception
- Leucopenia (< 3,000 leucocytes/mm3) or thrombocytopenia (< 100,000 platelets/mm3)
- Dyslipidemia (cholesterol or triglycerides > 260 mg/dl with treatment)
- Urinary tract infection
- Patients who cannot undergoing NMR
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites
A.O. Spedali Civili Di Brescia
Brescia
Alessandro Manzoni Hospital, Nephrology and Dialysis Department
Lecco, 23900
Modena Hospital
Modena, 41100
Dipartimento di Patologia Sistematica - Università Federico 2°
Naples, 80138
Ospedale "Guglielmo da Saliceto" - Nephrology and Dialysis Department
Piacenza, 29100
C.M.I.D. - Presidi Ospedalieri ASL 4
Torino, 10152
Ospedale Civile San Bortolo Vicenza
Vicenza
About this study
Official title: Everolimus on CKD (Chronic Kidney Disease) Progression in ADPKD Patients
The study will evaluate whether the administration of everolimus (1.5 mg/day) can slow down the progression of CKD in ADPKD patients.
Read the detailed description
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.
- Conditions
- Polycystic Kidney Diseases
- Being tested
- Everolimus
- Keywords
- ADPKD, CKD, Renal disease progression, Everolimus
- Medical subject headings
- Polycystic Kidney Diseases, Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Also called mTOR inhibitors
0.75 mg x 2 / day
| Study group | Role | What they receive |
|---|---|---|
| Everolimus | Experimental | Everolimus + standard therapy for CKD Receives: Drug: Everolimus |
| Control | No intervention | Standard therapy for CKD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of GFR (according to MDRD formula) during a two-year follow up
Measured: Two year-followup
Secondary outcomes (4)
reduction of creatinine clearance and GFR (according to Cockcroft-Gault formula) during a two-year follow up
Measured: 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
Measured: Two year-followup
safety profile of everolimus (leucopenia, thrombocytopenia, lipid profile and other adverse events
Measured: Two year-followup
evaluation of phosphatemia, phosphaturia and urinary cytokines on primary end point
Measured: Two year-followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2009 (estimated)
- Study startJun 2008
- Primary completionJan 2014
- Study completionJun 2015
Why it stopped: After primary completition date, experimental drug was no longer available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Kidney DiseasesStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- A. Manzoni Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Francesco Locatelli, A. Manzoni Hospital
- Investigators
- Francesco Locatelli, MD, Study chair, Nephrology and Dialysis Department - A. Manzoni Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01009957
- Sponsor's protocol ID
- PolEver
- Status last verified
- Jun 2015
- First submitted
- 6 Nov 2009
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Everolimus on CKD (Chronic Kidney Disease) Progression in ADPKD Patients
- ClinicalTrials.gov ID
- NCT01009957
- Acronym / sponsor ID
- PolEver
- Conditions
- Polycystic Kidney Diseases
- Keywords
- ADPKD, CKD, Renal disease progression, Everolimus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After primary completition date, experimental drug was no longer available
- Enrolment
- 71 participants (actual)
- Lead sponsor
- A. Manzoni HospitalUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 9 Nov 2009 (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.
The study will evaluate whether the administration of everolimus (1.5 mg/day) can slow down the progression of CKD in ADPKD patients.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Everolimus | Experimental | Drug: EverolimusEverolimus + standard therapy for CKD |
| Control | No intervention | –Standard therapy for CKD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects over 18 years of both genders
- Clinical diagnosis of autosomal dominant polycystic kidney disease (ADPKD)
- GFR, according to MDRD formula, between 30 and 90 ml/min/1.73 mq
- Previous follow up of two years, with a creatinine evaluation at least once a year
- GFR reduction of at least 2.5 ml/min/year (according to MDRD formula)
Key exclusion criteria (5 listed)
- Pregnancy, lactating, males and females without adequate contraception
- Leucopenia (< 3,000 leucocytes/mm3) or thrombocytopenia (< 100,000 platelets/mm3)
- Dyslipidemia (cholesterol or triglycerides > 260 mg/dl with treatment)
- Urinary tract infection
- Patients who cannot undergoing NMR
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: mTOR inhibitors0.75 mg x 2 / day | Drug | Everolimus |
Primary outcome
Reduction of GFR (according to MDRD formula) during a two-year follow up
Time frame: Two year-followup
4 secondary outcomes
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
Results and safety
The study was stopped early (reason given: After primary completition date, experimental drug was no longer available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 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.
Francesco Locatelli, MD study chair
Nephrology and Dialysis Department - A. Manzoni Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Everolimus in people with Polycystic Kidney Diseases, run by A. Manzoni Hospital at 7 sites in Italy.
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 5 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 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: After primary completition date, experimental drug was no longer available). 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?
Reduction of GFR (according to MDRD formula) during a two-year follow up (time frame: Two year-followup). 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 23 Jun 2015.