Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000081415
Ethics application status
Approved
Date submitted
31/12/2024
Date registered
24/01/2025
Date last updated
24/01/2025
Date data sharing statement initially provided
24/01/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preoperative kidney assessment to predict long-term renal function after kidney removal surgery
Scientific title
Preoperative Kidney Functional Reserve assessment in patients undergoing nephrectomy as a predictor of long-term renal outcomes (PREDICT Study)
Secondary ID [1] 313621 0
None
Universal Trial Number (UTN)
Trial acronym
PREDICT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic kidney disease 336174 0
kidney donation 336176 0
nephrectomy 336175 0
kidney auto-transplantation 336178 0
kidney cancer 336177 0
Condition category
Condition code
Renal and Urogenital 332717 332717 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
No intervention.
Exposure is the need of total or partial unilateral nephrectomy surgery due to kidney donation, removal of kidney cancer or kidney auto-transplantation.
- what is involved for patients in this study: Recruited patients will have blood and urine samples collected before and after kidney surgery, for kidney biomarkers measurement. Pre and postoperative assessments include an oral protein shake to allow for evaluation of the kidney functional reserve before the surgery, 1 month after the surgery and 3 months after the surgery. Clinical data will be collected from medical records and from the patients.
- what is being observed in participants: postoperative change of kidney function within 1 year after the surgery, change in kidney functional reserve at 1 and 3 months after the surgery, change in albuminuria 1 year after the surgery.
- the anticipated time required to complete each assessment is: preoperative kidney functional reserve test for participants who agree to do it: 6 hours, each time, for 3 times: before the surgery, 1 month after the surgery and 3 months after the surgery.
- the overall duration of observation: from time of enrollment for 1 year.
Intervention code [1] 330214 0
Diagnosis / Prognosis
Intervention code [2] 330215 0
Early Detection / Screening
Comparator / control treatment
No control - it is an observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340244 0
Percentage of change of estimated glomerular filtration rate (eGFR) by CKD-EPI 2021 formula
Timepoint [1] 340244 0
1 year after the kidney surgery (percentage of change of eGFR at 1 year when compared to baseline before surgery)
Secondary outcome [1] 443462 0
change in kidney functional reserve
Timepoint [1] 443462 0
1 month and 3 months after surgery
Secondary outcome [2] 443463 0
change in albuminuria level
Timepoint [2] 443463 0
Before the surgery and at 1 year after the surgery.

Eligibility
Key inclusion criteria
Adult patients undergoing total or partial unilateral nephrectomy due to kidney donation, kidney cancer removal or kidney auto-transplantation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of malabsorption or chronic inflammatory bowel disease or short bowel syndrome (precluding preoperative assessment using a protein load)
2. History of pancreatic insufficiency (precluding preoperative assessment using a protein load)
3. History of kidney transplantation

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Preoperative Kidney Functional Reserve test and loss of kidney functional reserve will be used as independent variables in a model to predict long-term loss of kidney function and albuminuria within one year after the surgery, using mixed models.
Pre and postoperative kidney functional reserve tests will be compared by mixed models to verify for loss of kidney reserve after the surgery.
The number of patients is the number of consenting patients undergoing nephrectomy at the Prince of Wales Hospital for the 2 years of the study.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
23/09/2022
Date of last participant enrolment
Anticipated
Actual
24/09/2024
Date of last data collection
Anticipated
18/11/2025
Actual
Sample size
Target
63
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27444 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 27445 0
Prince of Wales Private Hospital - Randwick
Recruitment postcode(s) [1] 43556 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 318089 0
Charities/Societies/Foundations
Name [1] 318089 0
Lewis Foundation
Country [1] 318089 0
Australia
Funding source category [2] 318090 0
Charities/Societies/Foundations
Name [2] 318090 0
FAPESP (São Paulo Research Foundation)
Country [2] 318090 0
Brazil
Funding source category [3] 318088 0
Charities/Societies/Foundations
Name [3] 318088 0
Prince of Wales Foundation
Country [3] 318088 0
Australia
Primary sponsor type
Individual
Name
Professor Zoltan Endre, Nephrology Department at Prince of Wales Hospital
Address
Country
Australia
Secondary sponsor category [1] 320445 0
None
Name [1] 320445 0
Address [1] 320445 0
Country [1] 320445 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316736 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 316736 0
Ethics committee country [1] 316736 0
Australia
Date submitted for ethics approval [1] 316736 0
06/09/2021
Approval date [1] 316736 0
07/12/2021
Ethics approval number [1] 316736 0
2021/ETH11453

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

Contacts
Principal investigator
Name 138842 0
Prof Zoltan Endre
Address 138842 0
Prince of Wales Hospital, level 3 - High street, Randwick, NSW, 2031
Country 138842 0
Australia
Phone 138842 0
+61 408 616 776
Fax 138842 0
Email 138842 0
[email protected]
Contact person for public queries
Name 138843 0
Zoltan Endre
Address 138843 0
Prince of Wales Hospital, level 3 - High street, Randwick, NSW, 2031
Country 138843 0
Australia
Phone 138843 0
+61 408 616 776
Fax 138843 0
Email 138843 0
[email protected]
Contact person for scientific queries
Name 138844 0
Zoltan Endre
Address 138844 0
Prince of Wales Hospital, level 3 - High street, Randwick, NSW, 2031
Country 138844 0
Australia
Phone 138844 0
+61 408 616 776
Fax 138844 0
Email 138844 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Scientific community accessing international repositories.

Conditions for requesting access:
• -

What individual participant data might be shared?
• All de-identified data

What types of analyses could be done with individual participant data?
• Any

When can requests for individual participant data be made (start and end dates)?
From:
After study publication, no end limit.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• International repository (https://oaaustralasia.org/institution/csiro/)

Are there extra considerations when requesting access to 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.