Hypogonadal males undergoing hemodialysis (HD).
Conditions
Interventions
Trade Name: testosteronundekanoat (Nebido®)
Product Name: testosteronundekanoat
Pharmaceutical Form: Injection
CAS Number: 5949-44-0
Other descriptive name: TESTOSTERONE UNDECANOATE
Concentration unit
Sponsors
Dept of Renal medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Ambulant male HD patients (>3 months) at least 18 yrs of age • Signed written informed consent obtained • Screening non-fasting testosterone 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
Exclusion criteria: • Contraindication to treatment with Nebido®, elevation of prostate specific antigen (PSA =4.5 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 (300 U/kg/week) doses of ESA.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether Nebido® treatment during 9 months in hypogonadal HD men may translate into lower ESA dose requirements with stable hemoglobin levels within the recommended target interval (100-120 g/l). ;Secondary Objective: • To evaluate the efficacy of 9 months of Nebido® treatment to improve muscle mass and nutritional status in testosterone deficient men undergoing stable HD. • To assess changes in surrogate markers of inflammation and insulin resistance following 9 months of Nebido® treatment. • To assess expected improvements on quality of life and psychological health status following 9 months of Nebido® treatment. • To evaluate the health economy of Nebido treatment in ESA-treated HD patients. • To assess effect of 9 months of Nebido® treatment on bone health. ;Primary end point(s): The primary efficacy variable is the change in ESA requirements during the study period to maintain stable haemoglobin levels within the target interval of 100-120 g/l. ;Timepoint(s) of evaluation of this end point: 9 months treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Effects on hand grip strength, anthropometric measurements, body composition (by DEXA and bioimpedance) as well as biochemical markers of nutritional status. • Effects on inflammatory status • Effects on hemoglobin, iron status and other anemia markers • Effects on insulin resistance parameters • Effects on vascular and cardiovascular health (sphygmocor) • Effects on bone health (DEXA and PQcT) • Effects on quality of life, psychological health status, hospitalization rates and short-term outcome • Effects on DNA methylation • Effects on health economy • Mortality rate during the study • Hospitalization rates during the study period ;Timepoint(s) of evaluation of this end point: 9 months treatment period. | — |
Countries
Sweden
Contacts
Public ContactM99, Renal Medicine
Dept of Renal medicine
Outcome results
None listed