Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000797471
Ethics application status
Approved
Date submitted
4/06/2025
Date registered
25/07/2025
Date last updated
25/07/2025
Date data sharing statement initially provided
25/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Studies in Autosomal Dominant Polycystic Kidney Disease (ADPKD): Observational study on the impact of ADPKD on quality and activities of daily life
Scientific title
An Observational Study Evaluating the Impact of Autosomal Dominant Polycystic Kidney Disease (ADPKD) on Health-Related Quality of Life and Daily Functioning in Adults with ADPKD
Secondary ID [1] 314584 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This record is a follow up to the studies registered in ACTRN12625000785404

Health condition
Health condition(s) or problem(s) studied:
Autosomal Dominant Polycystic Kidney Disease (ADPKD) 337691 0
Condition category
Condition code
Renal and Urogenital 334026 334026 0 0
Kidney disease
Human Genetics and Inherited Disorders 334050 334050 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a single-centre, cross-sectional observational study involving adults diagnosed with Autosomal Dominant Polycystic Kidney Disease (ADPKD) who are capable of providing informed consent. The study comprises five sub-studies, and participants may be enrolled in one, several, or all sub-studies depending on eligibility and their preferences during the consent process. Most participants are expected to undertake sub-studies i, ii, and iv, with female participants additionally expected to undertake sub-study iii.

Sub-study details:

Patient-reported outcomes (Sub-study i):
Participants will complete two validated questionnaires at a single baseline visit:
Assessment of Quality of Life – 8 Dimensions (AQOL-8D) (20min)
McGill Pain Questionnaire (20min)

Attitudes to genetic testing in ADPKD (Sub-study ii):
Participants will complete a modified version of the International Genetics Literacy and Attitudes Survey (iGLAS16). (10min)
Additionally, some participants will be invited to participate in virtual focus groups. These sessions will be recorded and analysed using thematic analysis. (30min)
Single visit

Female patient experience of pregnancy and hormone use (Sub-study iii):
Female participants will complete a Women’s Health Questionnaire via REDCap. (10min)
Selected participants will also take part in virtual focus groups, with thematic analysis applied to the discussions. (45min)
Single visit

Onset and type of proteinuria in ADPKD (Sub-study iv):
This sub-study involves retrospective analysis of historical laboratory data, specifically urine albumin-to-creatinine ratio (UACR) and urine protein-to-creatinine ratio (UPCR).
No direct participant involvement is required.

Impact of ADPKD on sleep quality and patterns (Sub-study v):
Participants will wear a sleep tracking device at home for 10 consecutive nights.
Data collected will include sleep duration, quality, and disturbances. (2 visits, one to collect and one to return device approx 10 days apart)

Duration of Observation:

All data collection is cross-sectional and occurs at a single time point. There are no follow-up visits. Participation in questionnaires and focus groups is expected to take approximately 20–60 minutes depending on the number of sub-studies involved.
Intervention code [1] 331208 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341689 0
Health-related quality of life in adults with ADPKD
Timepoint [1] 341689 0
Single baseline study visit
Secondary outcome [1] 448349 0
Attitudes toward genetic testing in ADPKD
Timepoint [1] 448349 0
Single baseline study visit
Secondary outcome [2] 448483 0
Presence of proteinuria in ADPKD
Timepoint [2] 448483 0
Historical data only; no new data collection Once-off single timepoint at baseline visit
Secondary outcome [3] 448484 0
Explore sleep metrics in ADPKD patients. All sleep metrics (Duration of total sleep, duration of each stage of sleep, Frequency of waking, Frequency of experiencing disrupted sleep) will be access as a composite outcome.
Timepoint [3] 448484 0
10-night observation period from baseline visit
Secondary outcome [4] 449291 0
Pain experience in adults with ADPKD
Timepoint [4] 449291 0
Single baseline study visit
Secondary outcome [5] 449292 0
Attitudes toward genetic testing in ADPKD
Timepoint [5] 449292 0
Single baseline study visit
Secondary outcome [6] 449296 0
Female patient experience of pregnancy
Timepoint [6] 449296 0
Single baseline study visit
Secondary outcome [7] 449463 0
Female patient experience of hormone use
Timepoint [7] 449463 0
Single baseline study visit
Secondary outcome [8] 450013 0
Female patient experience of hormone use
Timepoint [8] 450013 0
Single baseline study visit
Secondary outcome [9] 450014 0
Female patient experience of hormone use
Timepoint [9] 450014 0
Single baseline study visit
Secondary outcome [10] 450015 0
Type of proteinuria in ADPKD
Timepoint [10] 450015 0
Historical data only; no new data collection Once-off single timepoint at baseline visit

Eligibility
Key inclusion criteria
Adult patients providing informed consent
Adult patients with a diagnosis of ADPKD
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give informed consent
Pregnancy or breastfeeding

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/07/2025
Actual
Date of last participant enrolment
Anticipated
28/06/2027
Actual
Date of last data collection
Anticipated
30/09/2027
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 28007 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 44210 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 319131 0
Hospital
Name [1] 319131 0
The Royal Melbourne Hospital
Country [1] 319131 0
Australia
Primary sponsor type
Hospital
Name
The Royal Melbourne Hospital
Address
Country
Australia
Secondary sponsor category [1] 321598 0
None
Name [1] 321598 0
Address [1] 321598 0
Country [1] 321598 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317726 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 317726 0
Ethics committee country [1] 317726 0
Australia
Date submitted for ethics approval [1] 317726 0
Approval date [1] 317726 0
27/02/2025
Ethics approval number [1] 317726 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141946 0
Prof Karen Dwyer
Address 141946 0
Royal Melbourne Hospital, 300 Grattan St, Parkville VIC 3050
Country 141946 0
Australia
Phone 141946 0
+61 3 93428361
Fax 141946 0
Email 141946 0
[email protected]
Contact person for public queries
Name 141947 0
Karen Dwyer
Address 141947 0
Royal Melbourne Hospital, 300 Grattan St, Parkville VIC 3050
Country 141947 0
Australia
Phone 141947 0
+61 3 93427143
Fax 141947 0
Email 141947 0
[email protected]
Contact person for scientific queries
Name 141948 0
Karen Dwyer
Address 141948 0
Royal Melbourne Hospital, 300 Grattan St, Parkville VIC 3050
Country 141948 0
Australia
Phone 141948 0
+61 3 93427143
Fax 141948 0
Email 141948 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.