NCT07260071

Brief Summary

The goal of this project is to measure the prevalence of Autosomal Dominant Polycystic Kidney Disease (ADPKD) and hypertension in the general population of children and young people at risk of ADPKD, using magnetic resonance imaging (MRI) for rapid diagnosis alongside genetic testing. The main question it aims to answer is: What is the prevalence of hypertension in a population sample of adolescents with ADPKD? Participants will have the following measurements performed:

  • Height and weight.
  • Blood pressure.
  • Non-invasive measurement of arterial stiffness.
  • Cardiac and renal MRI.
  • Blood sample.
  • Genetic testing.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Aug 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Aug 2025Mar 2028

Study Start

First participant enrolled

August 15, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

December 2, 2025

Status Verified

October 1, 2025

Enrollment Period

2.5 years

First QC Date

November 13, 2025

Last Update Submit

November 20, 2025

Conditions

Keywords

hypertensionchildrenyoung peopleautosomal dominant polycystic kidney diseasearterial stiffnessgenetic testingalbuminuriaproteinuria

Outcome Measures

Primary Outcomes (1)

  • Number of participants with hypertension in general population of children and young people at risk of ADPKD.

    Diagnosis of hypertension from clinic manual blood pressure and 24 hours ambulatory blood pressure measurement

    Day 1

Secondary Outcomes (5)

  • Number of participants diagnosed with ADPKD from renal MRI compared to the number from genetic testing.

    Day 1

  • Number of participants with cyst negative but gene positive ADPKD in this age group.

    Day 1

  • Number of participants with abnormal albuminuria in the population at risk of ADPKD.

    Single time point

  • Central blood pressure in young people with ADPKD compared to healthy controls

    Day 1

  • Arterial stiffness in young people with ADPKD compared to healthy controls

    Day 1

Study Arms (2)

ADPKD positive

Participants with positive renal MRI and/or genetic test for ADPKD

ADPKD negative

Participants with negative renal MRI and genetic test for ADPKD

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

General population of children and young people at risk of ADPKD

You may qualify if:

  • Age 12 - 17 years at the time of consent
  • Able to tolerate the key study investigations (office blood pressure measurement, ambulatory blood pressure measurement, MRI and blood test)
  • Parent with confirmed clinical diagnosis of ADPKD
  • Parent (if child \<16 years) or both parent and young person (if \>=16 years) consents to genetic testing for ADPKD and demonstrates understanding of the implications of this.

You may not qualify if:

  • years or above at the time of study entry
  • Unable to tolerate key study investigations
  • Presence of associated co-morbidities which make it difficult to interpret results, including congenital cardiac anomalies and known TSC-PKD1 mutations
  • Unwilling to undergo genetic testing for ADPKD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evelina London Children's Hospital

London, SE1 7EH, United Kingdom

RECRUITING

Related Publications (3)

  • Ecder T, Schrier RW. Cardiovascular abnormalities in autosomal-dominant polycystic kidney disease. Nat Rev Nephrol. 2009 Apr;5(4):221-8. doi: 10.1038/nrneph.2009.13.

    PMID: 19322187BACKGROUND
  • Pei Y, Obaji J, Dupuis A, Paterson AD, Magistroni R, Dicks E, Parfrey P, Cramer B, Coto E, Torra R, San Millan JL, Gibson R, Breuning M, Peters D, Ravine D. Unified criteria for ultrasonographic diagnosis of ADPKD. J Am Soc Nephrol. 2009 Jan;20(1):205-12. doi: 10.1681/ASN.2008050507. Epub 2008 Oct 22.

    PMID: 18945943BACKGROUND
  • Torres VE, Harris PC, Pirson Y. Autosomal dominant polycystic kidney disease. Lancet. 2007 Apr 14;369(9569):1287-1301. doi: 10.1016/S0140-6736(07)60601-1.

    PMID: 17434405BACKGROUND

Related Links

MeSH Terms

Conditions

Polycystic Kidney, Autosomal DominantHypertensionAlbuminuriaProteinuria

Condition Hierarchy (Ancestors)

Polycystic Kidney DiseasesKidney Diseases, CysticKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCiliopathiesGenetic Diseases, InbornVascular DiseasesCardiovascular DiseasesUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Manish Sinha, PhD, MRCP (UK), MRCPCH

    King's College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Boxer, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2025

First Posted

December 2, 2025

Study Start

August 15, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

December 2, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

IPD will not be shared beyond the study team.

Locations