RADIOLOGICAL AND CLINICAL EVALUATION OF RENAL EMBOLIZATION USING EVOH IN DIALYSIS PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE: A PROSPECTIVE LONGITUDINAL OBSERVATIONAL 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.

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 Overview

• Status: Recruiting
• Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • Recruiting
      • Fondazione IRCCS Policlinico San Matteo di Pavia
      • Contact: Ilaria Fiorina, MD; Phone Number: 0382 503750; Email: i.fiorina@smatteo.pv.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

patients undergoing haemodialysis, suffering from autosomal dominant polycystic kidney disease, who have undergone renal embolisation at the Foundation's Interventional Radiology Department.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Contraindications to MRI without contrast (ferromagnetic implants, incompatible pacemakers, surgical clips, severe claustrophobia or other conditions that may interfere with MRI)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 1 month, 3 months, 6 months and 12 months

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2020
• Primary Completion (Estimated): August 17, 2026
• Study Completion (Estimated): August 17, 2026

Study Registration Dates

• First Submitted: April 10, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ciliopathies; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genetic Diseases, Inborn; Congenital Abnormalities; Abnormalities, Multiple; Kidney Diseases, Cystic; Polycystic Kidney Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Polycystic Kidney, Autosomal Dominant
• Other Study ID Numbers: ADPKD Disease

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No