A randomised, double-blind study to investigate the effects of intramuscular testosterone undecanoate (Nebido®) on anemia treatment in testosterone deficient men undergoing hemodialysis. - DiaTest

Dept of Renal medicine0 个研究点目标入组 40 人开始时间: 2011年12月5日最近更新: 2024年2月19日

适应症

试验速览

暂无简介。

•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

•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.

发起方

Dept of Renal medicine