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Prospective Longitudinal EVOH Renal Embolization Study in ADPKD

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Summary

NIH has registered a prospective longitudinal observational study (NCT07535385) evaluating the radiological and clinical outcomes of renal embolization using ethylene-vinyl alcohol copolymer (EVOH) in dialysis patients with autosomal dominant polycystic kidney disease (ADPKD). The study aims to assess renal volume changes, complications, and prognostic factors in affected patients. Results may inform treatment strategies for ADPKD-related renal failure.

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What changed

The NIH registered a new observational clinical study on ClinicalTrials.gov examining the use of ethylene-vinyl alcohol copolymer (EVOH) for renal embolization in patients with autosomal dominant polycystic kidney disease on dialysis. The study will prospectively track renal volume changes, clinical outcomes, and complications over time. ADPKD affects 1 in 400-1,000 births and represents 5% of dialysis patients and 10% of end-stage renal failure cases in Europe.

Healthcare providers and clinical investigators involved in nephrology, interventional radiology, and dialysis care may encounter patients eligible for enrollment. The study's findings on renal embolization efficacy could influence future treatment protocols for ADPKD-related complications. No compliance obligations are imposed by this registration; it represents a study documentation and enrollment facilitation mechanism.

Archived snapshot

Apr 18, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

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

Observational NCT07535385 Kind: OBSERVATIONAL Apr 17, 2026

Abstract

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,...

Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)

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Last updated

Classification

Agency
NIH
Published
April 17th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07535385

Who this affects

Applies to
Healthcare providers Clinical investigators Patients
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration Renal procedure evaluation Patient enrollment
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Medical Devices Pharmaceuticals

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