Autosomal Dominant Polycystic Kidney Disease (ADPKD)NCT07535385
RADIOLOGICAL AND CLINICAL EVALUATION OF RENAL EMBOLIZATION USING EVOH IN DIALYSIS PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE: A PROSPECTIVE LONGITUDINAL OBSERVATIONAL STUDY
An observational study of Autosomal Dominant Polycystic Kidney Disease (ADPKD), run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
Autosomal dominant polycystic kidney disease (ADPKD) is an inherited cystic disorder characterised by the progressive degeneration of the renal parenchyma into cystic formations, with involvement of other organs to varying degrees and incidence (liver, pancreas and brain). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 17 Aug 2020to 17 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Adult, Older adult
Study population: patients undergoing haemodialysis, suffering from autosomal dominant polycystic kidney disease, who have undergone renal embolisation at the Foundation's Interventional Radiology Department.
Who may be able to join
- aged over 18 and under 75
- written informed consent
- Patients with autosomal dominant polycystic kidney disease, with a kidney volume of between 2000 and 5000 mL, on dialysis, undergoing renal embolisation
Who cannot join
- Contraindications to MRI without contrast (ferromagnetic implants, incompatible pacemakers, surgical clips, severe claustrophobia or other conditions that may interfere with MRI)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Lombardy, 27100
Ilaria Fiorina, MD, 0382 503750, i.fiorina@smatteo.pv.it
About this study
Autosomal dominant polycystic kidney disease (ADPKD) is an inherited cystic disorder characterised by the progressive degeneration of the renal parenchyma into cystic formations, with involvement of other organs to varying degrees and incidence (liver, pancreas and brain).
This condition is the most common inherited kidney disorder; in fact, it affects 1 in 400-1,000 births and has a prevalence of 5% among dialysis patients and an incidence of 10% among patients with end-stage renal failure in Europe. It is caused by mutations in the PKD1 or PKD2 genes, which are involved in the production of an abnormal protein that leads to tubular dysplasia.
Read more
Cystic degeneration leads to progressive loss of renal function, with the development of hypertension, haematuria and concomitant enlargement of the renal parenchyma. The progression of the disease is precisely marked by an increase in renal volume. The increase in the organ's overall volume is secondary to the development and enlargement of cysts, whilst the proportion of functioning renal parenchyma progressively decreases. For these reasons, the increase in renal volume over time is a powerful predictor of the risk of end-stage renal disease (ESRD).
In addition to its prognostic significance, the enlargement of the kidneys is itself a cause of complications. Indeed, the space occupied within the abdomen can become so extensive as to cause abdominal distension, malaise, pain, loss of appetite, constipation, nausea and vomiting, reduced diaphragmatic movement, breathing difficulties and lower back pain. Overall, patients' quality of life can be severely compromised.
It is not uncommon for the kidneys of patients with ADPKD to occupy the pelvic cavity, the preferred site for kidney transplant placement, which represents the optimal treatment option for the disease once ESRD has been reached. This situation, which is not uncommon, represents a temporary contraindication to kidney transplantation: delaying the procedure also has repercussions on the patient's survival.
The contraindication to transplantation due to anatomical unavailability has so far necessitated surgical nephrectomy (so-called 'debridement nephrectomy') as the sole preventive or pre-transplant therapeutic option. Nephrectomy carries the risks inherent in surgery, including haemorrhage, herniation of the abdominal wall, vascular complications of varying severity-such as arteriovenous fistulas, thrombosis, and vascular wall injury-and the risk of infection. Surgical nephrectomy also has a negative impact on the subsequent possibility of using the peritoneal membrane for dialysis (peritoneal dialysis) and, should blood transfusions be required to correct intraoperative blood loss, contributes to increasing the likelihood of the patient becoming immunised, with the associated risks of reduced availability of compatible donors (so-called hyperimmune patients), and, in any case, a higher risk of acute and chronic rejection, conditions that negatively impact transplant survival.
Given the high risks associated with nephrectomy, a non-invasive alternative has been proposed: reduction of renal volume via transcatheter arterial embolisation.
Renal embolisation can be performed in the Interventional Radiology department via the controlled occlusion of renal vessels using a liquid embolisation agent composed of ethylene vinyl alcohol (EVOH). The literature reports the assessment of embolised patients using CT without contrast medium, but recent technological innovations allow for accurate and precise volumetric assessment of organs using MRI without contrast medium, with reduced inter-operator variability and without the need to subject the patient to ionising radiation during follow-up.
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the radiological outcome of renal embolisation in terms of the reduction in the volume of the treated kidney as measured by MRI without contrast medium
to assess the radiological outcome of renal embolisation performed at our Foundation in comparison with data reported in the literature, in terms of the reduction in the volume of the treated kidney as measured by MRI without contrast medium compared with baseline and with the contralateral kidney prior to treatment, and at 1, 3, 6 and 12 months.
Measured: up to 1 month, 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start17 Aug 2020
- Primary completion17 Aug 2026 (estimated)
- Study completion17 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilaria Fiorina, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535385
- Sponsor's protocol ID
- ADPKD Disease
- Status last verified
- Mar 2026
- First submitted
- 10 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RADIOLOGICAL AND CLINICAL EVALUATION OF RENAL EMBOLIZATION USING EVOH IN DIALYSIS PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE: A PROSPECTIVE LONGITUDINAL OBSERVATIONAL STUDY
- ClinicalTrials.gov ID
- NCT07535385
- Acronym / sponsor ID
- ADPKD Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 17 Aug 2026 (estimated)
- Study completion
- 17 Aug 2026 (estimated)
- First posted
- 17 Apr 2026 (actual)
- 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.
Autosomal dominant polycystic kidney disease (ADPKD) is an inherited cystic disorder characterised by the progressive degeneration of the renal parenchyma into cystic formations, with involvement of other organs to varying degrees and incidence (liver, pancreas and brain).
This condition is the most common inherited kidney disorder; in fact, it affects 1 in 400-1,000 births and has a prevalence of 5% among dialysis patients and an incidence of 10% among patients with end-stage renal failure in Europe. It is caused by mutations in the PKD1 or PKD2 genes, which are involved in the production of an abnormal protein that leads to tubular dysplasia.
Cystic degeneration leads to progressive loss of renal function, with the development of hypertension, haematuria and concomitant enlargement of the renal parenchyma. The progression of the disease is precisely marked by an increase in renal volume. The increase in the organ's overall volume is secondary to the development and enlargement of cysts, whilst the proportion of functioning renal parenchyma progressively decreases. For these reasons, the increase in renal volume over time is a powerful predictor of the risk of end-stage renal disease (ESRD).
In addition to its prognostic significance, the enlargement of the kidneys is itself a cause of complications. Indeed, the space occupied within the abdomen can become so extensive as to cause abdominal distension, malaise, pain, loss of appetite, constipation, nausea and vomiting, reduced diaphragmatic movement, breathing difficulties and lower back pain. Overall, patients' quality of life can be severely compromised.
It is not uncommon for the kidneys of patients with ADPKD to occupy the pelvic cavity, the preferred site for kidney transplant placement, which represents the optimal treatment option for the disease once ESRD has been reached. This situation, which is not uncommon, represents a temporary contraindication to kidney transplantation: delaying the procedure also has repercussions on the patient's survival.
The contraindication to transplantation due to anatomical unavailability has so far necessitated surgical nephrectomy (so-called 'debridement nephrectomy') as the sole preventive or pre-transplant therapeutic option. Nephrectomy carries the risks inherent in surgery, including haemorrhage, herniation of the abdominal wall, vascular complications of varying severity-such as arteriovenous fistulas, thrombosis, and vascular wall injury-and the risk of infection. Surgical nephrectomy also has a negative impact on the subsequent possibility of using the peritoneal membrane for dialysis (peritoneal dialysis) and, should blood transfusions be required to correct intraoperative blood loss, contributes to increasing the likelihood of the patient becoming immunised, with the associated risks of reduced availability of compatible donors (so-called hyperimmune patients), and, in any case, a higher risk of acute and chronic rejection, conditions that negatively impact transplant survival.
Given the high risks associated with nephrectomy, a non-invasive alternative has been proposed: reduction of renal volume via transcatheter arterial embolisation.
Renal embolisation can be performed in the Interventional Radiology department via the controlled occlusion of renal vessels using a liquid embolisation agent composed of ethylene vinyl alcohol (EVOH). The literature reports the assessment of embolised patients using CT without contrast medium, but recent technological innovations allow for accurate and precise volumetric assessment of organs using MRI without contrast medium, with reduced inter-operator variability and without the need to subject the patient to ionising radiation during follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients undergoing haemodialysis, suffering from autosomal dominant polycystic kidney disease, who have undergone renal embolisation at the Foundation's Interventional Radiology Department.
Key inclusion criteria (3 listed)
- aged over 18 and under 75
- written informed consent
- Patients with autosomal dominant polycystic kidney disease, with a kidney volume of between 2000 and 5000 mL, on dialysis, undergoing renal embolisation
Key exclusion criteria (1 listed)
- Contraindications to MRI without contrast (ferromagnetic implants, incompatible pacemakers, surgical clips, severe claustrophobia or other conditions that may interfere with MRI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of the radiological outcome of renal embolisation in terms of the reduction in the volume of the treated kidney as measured by MRI without contrast medium
Time frame: up to 1 month, 3 months, 6 months and 12 months
to assess the radiological outcome of renal embolisation performed at our Foundation in comparison with data reported in the literature, in terms of the reduction in the volume of the treated kidney as measured by MRI without contrast medium compared with baseline and with the contralateral kidney prior to treatment, and at 1, 3, 6 and 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autosomal Dominant Polycystic Kidney Disease (ADPKD), run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 17 Apr 2026. 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 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Assessment of the radiological outcome of renal embolisation in terms of the reduction in the volume of the treated kidney as measured by MRI without contrast medium (time frame: up to 1 month, 3 months, 6 months and 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 17 Apr 2026.