Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001137583
Ethics application status
Approved
Date submitted
14/05/2024
Date registered
20/09/2024
Date last updated
20/09/2024
Date data sharing statement initially provided
20/09/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect Of Testosterone Supplements On Anemia And Quality Of Life Amongst Patients On Regular Hemodialysis
Scientific title
Effect Of Testosterone Replacement On Anemia And Quality Of Life Amongst Patients On Maintenance Hemodialysis
Secondary ID [1] 312923 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Renal Disease 333708 0
Condition category
Condition code
Renal and Urogenital 330389 330389 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Injection testosterone enanthate 250mg subcut will be given once fortnightly for 6 months
it will be administered by a dialysis nurse 30 mins after each dialysis session. Adherence would be ensured as it will be administered and documented by a dialysis nurse.
Intervention code [1] 328522 0
Treatment: Drugs
Comparator / control treatment
Injection normal saline 0.5ml subcut will be given once fortnightly for 6 months
it will be administered by a dialysis nurse 30 mins after each dialysis session. Adherence would be ensured as it will be administered and documented by a dialysis nurse.
Control group
Placebo

Outcomes
Primary outcome [1] 338153 0
any change in hemoglobin levels
Timepoint [1] 338153 0
Baseline and at every months upto 6 months following the intervention
Secondary outcome [1] 434721 0
Quality of life
Timepoint [1] 434721 0
Baseline and at every month till 6 months following intervention

Eligibility
Key inclusion criteria
1. Patients diagnosed with end-stage renal disease (ESRD) requiring maintenance hemodialysis.
2. Patients with documented anemia, defined as haemoglobin levels < 10 g/dL
3. Patients with stable medical conditions, defined as absence of acute illness or major surgical procedures within the past three months.
4. Patients who have been on a stable hemodialysis regimen for at least three months prior to enrollment.
Minimum age
18 Years
Maximum age
80 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with known hypersensitivity or contraindications to testosterone replacement therapy (TRT).
2. Patients with active malignancy, including prostate cancer.
3. Patients with uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg).
4. Patients with severe liver disease (e.g., cirrhosis) or severe hepatic dysfunction (e.g., Child-Pugh class B or C).
5. Patients with severe cardiac disease (e.g., congestive heart failure, recent myocardial infarction) or unstable cardiovascular conditions.
6. Patients with a history of thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism).
7. Patients with significant psychiatric illness or cognitive impairment that may affect their ability to participate in the study or provide informed consent.

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)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
1/05/2024
Date of last participant enrolment
Anticipated
Actual
30/06/2024
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
24
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 26292 0
Pakistan
State/province [1] 26292 0

Funding & Sponsors
Funding source category [1] 316442 0
Hospital
Name [1] 316442 0
Pakistan Emirates Military Hospital
Country [1] 316442 0
Pakistan
Primary sponsor type
Individual
Name
Dr Qurat Ul Ain Azam - Pak Emirates Military Hospital
Address
Country
Pakistan
Secondary sponsor category [1] 318612 0
None
Name [1] 318612 0
Address [1] 318612 0
Country [1] 318612 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315234 0
Ethical Review Commitee, Pak Emirates Military Hospital, Rawalpindi
Ethics committee address [1] 315234 0
Ethics committee country [1] 315234 0
Pakistan
Date submitted for ethics approval [1] 315234 0
02/10/2023
Approval date [1] 315234 0
05/10/2023
Ethics approval number [1] 315234 0
a/28/erc/598/23

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

Contacts
Principal investigator
Name 134078 0
Dr Qurat Ul Ain Azam
Address 134078 0
Pak Emirates Military Hospital , The Mall, Rawalpindi, 46000, Punjab, Pakistan
Country 134078 0
Pakistan
Phone 134078 0
+923245105840
Fax 134078 0
Email 134078 0
[email protected]
Contact person for public queries
Name 134079 0
Qurat Ul Ain Azam
Address 134079 0
Pak Emirates Military Hospital , The Mall, Rawalpindi, 46000, Punjab, Pakistan
Country 134079 0
Pakistan
Phone 134079 0
+923245105840
Fax 134079 0
Email 134079 0
[email protected]
Contact person for scientific queries
Name 134080 0
Qurat Ul Ain Azam
Address 134080 0
Pak Emirates Military Hospital , The Mall, Rawalpindi, 46000, Punjab, Pakistan
Country 134080 0
Pakistan
Phone 134080 0
+923245105840
Fax 134080 0
Email 134080 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22341Ethical approval  [email protected]



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.