Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001237673
Ethics application status
Approved
Date submitted
14/07/2023
Date registered
30/11/2023
Date last updated
30/11/2023
Date data sharing statement initially provided
30/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of extra-renal effects of SGLT2-inhibitors in anuric haemodialysis patients using microneurography
Scientific title
Assessment of the effect of Empagliflozin on sympathetic tone and extra-renal effects in anuric haemodialysis patients using microneurography
Secondary ID [1] 310092 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Kidney Disease (ESKD) with Anuria 330644 0
Condition category
Condition code
Renal and Urogenital 327467 327467 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Effects of Empagliflozin on Sympathetic Nervous System; assessed using microneurography

- the dose administered, 25mg once daily in the morning,
- the duration of administration, 6 weeks, then stop
- the mode of administration, oral tablet,
- Strategies used to monitor adherence to the intervention: smart phone reminder, pill counting, and reminder on dialysis sessions,
Intervention code [1] 326492 0
Treatment: Drugs
Comparator / control treatment
No control group. Effect of the medication will be compared pre vs post exposure.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335333 0
Difference in sympathetic tone before and after initiation of Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors measured at weeks 0, 3, and 6. Difference in sympathetic tone is measured using a tungsten microelectrode inserted in a muscle fascicle of the peroneal nerve at the fibular head.
Timepoint [1] 335333 0
Week 0 (baseline), weeks 3 and 6 (primary endpoint) post-commencement of intervention,
Secondary outcome [1] 423987 0
•Variability in sympathetic response to acute stressors (mental stress, cold pressor, and hand grip tests) as measured by microneurography (as a composite secondary outcome)
Timepoint [1] 423987 0
Week 0 (baseline), weeks 3 and 6 post-commencement of intervention,
Secondary outcome [2] 428114 0
•Differences in sympathetic tone changes through the study between diabetic vs non-diabetic participants enrolled using microneurographic recordings of peroneal nerve
Timepoint [2] 428114 0
Week 0 (baseline), weeks 3 and 6 post-commencement of intervention,
Secondary outcome [3] 428115 0
•Change in blood pressure throughout the study using digital blood pressure machine
Timepoint [3] 428115 0
Week 0 (baseline), weeks 3 and 6 post-commencement of intervention,
Secondary outcome [4] 428116 0
•Changes in glycaemic parameters throughout the study, using plasma glucose levels and capillary blood glucose levels
Timepoint [4] 428116 0
Week 0 (baseline), weeks 3 and 6 post-commencement of intervention,
Secondary outcome [5] 428117 0
•Changes in Brain Natriuretic Peptide (BNP) plasma levels throughout the study
Timepoint [5] 428117 0
Week 0 (baseline), weeks 3 and 6 post-commencement of intervention,
Secondary outcome [6] 428118 0
•Changes in central blood pressure variability throughout the study assessed using digital blood pressure machine
Timepoint [6] 428118 0
Week 0 (baseline), weeks 3 and 6 post-commencement of intervention,
Secondary outcome [7] 428501 0
•Changes in heart rate variability throughout the study assessed using a pulse oximetry
Timepoint [7] 428501 0
Week 0 (baseline), weeks 3 and 6 post-commencement of intervention,
Secondary outcome [8] 428502 0
•Changes in postural blood pressure variability throughout the study assessed using digital blood pressure machine
Timepoint [8] 428502 0
Week 0 (baseline), weeks 3 and 6 post-commencement of intervention,

Eligibility
Key inclusion criteria
• Adults 18 years and older
• Anuric haemodialysis patients
• Able to mobilise independently
• BP <160/90 mmHg
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with Type 1 Diabetes
• Patients on SGLT2-inhbitors prior to the study will be excluded.
• History of Unilateral or Bilateral Nephrectomy, chronic liver disease, heart failure [New York Heart Association (NYHA) class II-IV}, or secondary hypertension
• Pregnancy (females of childbearing potential must have negative pregnancy test)
• Relative or absolute contraindication to empagliflozin, including active urinary or genital tract infection, or known drug allergy
• Severe peripheral vascular disease or neuropathy
• Initiation of alpha-blockers, beta-blockers or moxonidine within the preceding 6 weeks
• Cardiovascular event(s) within the last 6 months
• Unstable psychiatric condition or inability to understand and attend appointments
• On medications such as corticosteroids, multiple antidepressants, and antipsychotics

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



Intervention assignment
Single group
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
continuous variables are expressed as mean ± standard deviation (SD) for normally distributed data or as median [interquartile range (IQR)] for non-normally distributed data, and as proportions for categorical variables.

Assessment of the difference in the value pre and post intervention will be assessed by paired T test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2023
Actual
Date of last participant enrolment
Anticipated
31/01/2024
Actual
Date of last data collection
Anticipated
13/03/2024
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 25096 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 40766 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 314254 0
Hospital
Name [1] 314254 0
Royal Perth Hospital
Country [1] 314254 0
Australia
Primary sponsor type
Other
Name
Dobney Hypertension Centre
Address
Royal Perth Hospital - Medical research Foundation, 50 Murray St, Perth WA 6000
Country
Australia
Secondary sponsor category [1] 316191 0
None
Name [1] 316191 0
Address [1] 316191 0
Country [1] 316191 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313374 0
Royal Perth Hospital-Human Research Ethics Committee
Ethics committee address [1] 313374 0
Ethics committee country [1] 313374 0
Australia
Date submitted for ethics approval [1] 313374 0
01/09/2022
Approval date [1] 313374 0
15/02/2023
Ethics approval number [1] 313374 0
RGS0000003840

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

Contacts
Principal investigator
Name 127922 0
Dr Awf Abdulrahman Shaban
Address 127922 0
Nephrology Department, Royal Perth Hospital, Victoria Square, Perth WA 6000
Country 127922 0
Australia
Phone 127922 0
+61455332490
Fax 127922 0
Email 127922 0
[email protected]
Contact person for public queries
Name 127923 0
Awf Abdulrahman Shaban
Address 127923 0
Nephrology Department, Royal Perth Hospital, Victoria Square, Perth WA 6000
Country 127923 0
Australia
Phone 127923 0
+61892242244
Fax 127923 0
Email 127923 0
[email protected]
Contact person for scientific queries
Name 127924 0
Awf Abdulrahman Shaban
Address 127924 0
Nephrology Department, Royal Perth Hospital, Victoria Square, Perth WA 6000
Country 127924 0
Australia
Phone 127924 0
+61455332490
Fax 127924 0
Email 127924 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
not available yet


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19650Study protocol    386216-(Uploaded-11-07-2023-03-54-27)-Study-related document.docx
19651Ethical approval    386216-(Uploaded-11-07-2023-03-55-16)-Study-related document.pdf
19652Informed consent form    386216-(Uploaded-20-10-2023-18-26-37)-Study-related document.docx



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.