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Clinical Trials/ACTRN12624001137583
ACTRN12624001137583Active, not recruitingPhase 4

Effect Of Testosterone Replacement On Anemia And Quality Of Life Amongst Patients On Maintenance Hemodialysis

Dr Qurat Ul Ain Azam - Pak Emirates Military Hospital0 sites24 target enrollmentStarted: September 20, 2024Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Active, not recruiting
Sponsor
Enrollment
24
Primary Endpoint
any change in hemoglobin levels[Haemoglobin levels by running blood samples in automated hematology cbc analysers Baseline and at every months upto 6 months following the intervention]

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomised controlled trial
Primary Purpose
Treatment
Masking
Blinded (masking used)

Eligibility Criteria

Ages
18 Years to 80 Years (—)
Sex
Male

Inclusion Criteria

  • Patients diagnosed with end-stage renal disease (ESRD) requiring maintenance hemodialysis.
  • Patients with documented anemia, defined as haemoglobin levels < 10 g/dL
  • Patients with stable medical conditions, defined as absence of acute illness or major surgical procedures within the past three months.
  • Patients who have been on a stable hemodialysis regimen for at least three months prior to enrollment.

Exclusion Criteria

  • Patients with known hypersensitivity or contraindications to testosterone replacement therapy (TRT).
  • Patients with active malignancy, including prostate cancer.
  • Patients with uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg).
  • Patients with severe liver disease (e.g., cirrhosis) or severe hepatic dysfunction (e.g., Child-Pugh class B or C).
  • Patients with severe cardiac disease (e.g., congestive heart failure, recent myocardial infarction) or unstable cardiovascular conditions.
  • Patients with a history of thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism).
  • Patients with significant psychiatric illness or cognitive impairment that may affect their ability to participate in the study or provide informed consent.

Outcomes

Primary Outcomes

any change in hemoglobin levels[Haemoglobin levels by running blood samples in automated hematology cbc analysers Baseline and at every months upto 6 months following the intervention]

Secondary Outcomes

  • Quality of life[Questionnaire base quality of life assessment utilizing WHOQOL-BREF Baseline and at every month till 6 months following intervention]

Investigators

Sponsor
Dr Qurat Ul Ain Azam - Pak Emirates Military Hospital

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