Effect of testosterone in male patients on regular hemodialysis

Phase 1

• Conditions: Hypogonadal males undergoing hemodialysis (HD).; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2011-005439-20-SE
• Lead Sponsor: Dept of Renal medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-05
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Ambulant male HD patients (>3 months) at least 18 yrs of age
• Signed written informed consent obtained
• Screening non-fasting testosterone <12 nmol/L in two consecutive tests (>2 days apart) on a HD day.
• Stable ESA dose within the interval equivalent to 25-300 I.U. kg/week during the 6 weeks before inclusion
• Mean pre-dialysis Hb during screening in the interval 90-120 g/l.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

• Contraindication to treatment with Nebido®, elevation of prostate specific antigen (PSA =4.5 ng/ml if <70 yr and =6.5 ng/ml if >70 yr) or severe symptomatic benign prostatic hyperplasia
• Known acute bacterial infection requiring antibiotic treatment
• Clinically significant overt bleeding
• Active malignancy
• Patients taking prednisolone in doses >10 mg
• Antiandrogens or estrogen medication
• Uncontrolled epilepsia
• Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of the normal range
• Planned living donor kidney transplantation
• Acute coronary syndrome or stroke within the 6 months prior to screening
• Concomitant, severe psychiatric disorders or other conditions which, in the opinion of the investigator, make participation unacceptable
• Participation in another interventional clinical trial within previous 30 days
• Inability to fully comprehend and/or perform study procedures in the investigator’s opinion
• Patient with very low (<25 U/kg/week) or high (>300 U/kg/week) doses of ESA.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified