Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000966493
Ethics application status
Approved
Date submitted
19/07/2016
Date registered
22/07/2016
Date last updated
8/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of the use of spironolactone on the endothelial glycocalyx in patients with kidney transplants
Scientific title
Assessment of the use of spironolactone on the endothelial glycocalyx in patients with kidney transplants
Secondary ID [1] 289638 0
E35-2015
Universal Trial Number (UTN)
Trial acronym
ASGARD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney transplant 299525 0
Condition category
Condition code
Renal and Urogenital 299502 299502 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Spironolactone 25mg, oral tablet, once daily for 2 months. Adherence to be monitored by questionnaire and return of empty drug packets. Wash-out period of 1 month. Then crossover to standard-of-care for 2 months (total trial period of 5 months).
Intervention code [1] 295339 0
Treatment: Drugs
Comparator / control treatment
Compared to standard-of-care - i.e. regular nephrologist or general practitioner care and continuation of any current medications,
Control group
Active

Outcomes
Primary outcome [1] 298987 0
Change in glycocalyx parameters by:
1. Glycocheck value (sublingual camera measurement of the glycocalyx)
2. ELISA of syndecan-1 on serum samples
3. ELISA of hyaluronan on serum samples
Timepoint [1] 298987 0
5 months post initial randomisation of study arm
Secondary outcome [1] 325824 0
Change in markers of endothelial dysfunction by:
1. ELISA of von Willebrand Factor on serum samples
2. ELISA of vascular cell adhesion molecule-1 (VCAM-1) on serum samples
3. Urinary microalbuminuria
Timepoint [1] 325824 0
5 months post initial randomisation of study arm

Eligibility
Key inclusion criteria
Kidney transplant >1 year ago
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Malignancy, pregnancy, inability to consent, known haematological disorders, serum potassium > 5.0 mmol/L

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on a previously published article (Nieuwdorp et al, J Appl Physiol 2008), the number required to detect a 0.2micrometre difference in the glycocalyx for a significance level of 5% and power of 80% in a paired design (i.e. measuring outcomes before and after an intervention) is n=10. We plan to recruit n=10 in each arm (total 20).

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
26/07/2016
Actual
5/08/2016
Date of last participant enrolment
Anticipated
Actual
23/01/2017
Date of last data collection
Anticipated
Actual
22/08/2017
Sample size
Target
20
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6223 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 6224 0
Maroondah Hospital - Ringwood East
Recruitment hospital [3] 6225 0
Angliss Hospital - Upper Ferntree Gully
Recruitment postcode(s) [1] 13638 0
3128 - Box Hill
Recruitment postcode(s) [2] 13639 0
3135 - Ringwood East
Recruitment postcode(s) [3] 13640 0
3156 - Upper Ferntree Gully

Funding & Sponsors
Funding source category [1] 294089 0
University
Name [1] 294089 0
Eastern Clinical Research Unit, Monash University
Country [1] 294089 0
Australia
Primary sponsor type
Hospital
Name
Department of Renal Medicine, Box Hill Hospital
Address
Department of Renal Medicine, Box Hill Hospital, Level 2, 5 Arnold Street, Box Hill 3128, Victoria
Country
Australia
Secondary sponsor category [1] 292922 0
None
Name [1] 292922 0
Address [1] 292922 0
Country [1] 292922 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295505 0
Eastern Health HREC
Ethics committee address [1] 295505 0
Level 2, 5 Arnold Street, Box Hill 3128, Victoria
Ethics committee country [1] 295505 0
Australia
Date submitted for ethics approval [1] 295505 0
19/05/2016
Approval date [1] 295505 0
07/07/2016
Ethics approval number [1] 295505 0

Summary
Brief summary
The glycocalyx is a particle that is important in maintaining blood vessel health. Patients with kidney disease have impaired blood vessel function, and previous studies have indicated that the glycocalyx is affected in those who have kidney disease. Laboratory studies indicate that the use of spironolactone, a common medication used for blood pressure, heart failure and to reduce protein in the urine, can have beneficial effects on the glycocalyx. The purpose of this study is to assess if the glycocalyx is affected in people who have kidney transplants, and whether spironolactone has any additional protective benefits on the glycocalyx.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67294 0
Dr Hui Liew
Address 67294 0
Department of Renal Medicine, Box Hill Hospital, Level 2, 5 Arnold Street, Box Hill 3128, Victoria
Country 67294 0
Australia
Phone 67294 0
+61390918870
Fax 67294 0
+61398996810
Email 67294 0
[email protected]
Contact person for public queries
Name 67295 0
Dr Hui Liew
Address 67295 0
Department of Renal Medicine, Box Hill Hospital, Level 2, 5 Arnold Street, Box Hill 3128, Victoria
Country 67295 0
Australia
Phone 67295 0
+61390918870
Fax 67295 0
+61398996810
Email 67295 0
[email protected]
Contact person for scientific queries
Name 67296 0
Dr Hui Liew
Address 67296 0
Department of Renal Medicine, Box Hill Hospital, Level 2, 5 Arnold Street, Box Hill 3128, Victoria
Country 67296 0
Australia
Phone 67296 0
+61390918870
Fax 67296 0
+61398996810
Email 67296 0
[email protected]

No information has been provided regarding IPD availability


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.