Nandrolone decanoate as anabolic therapy in chronic kidney disease: a randomized phase II dose-finding study.
OBJECTIVE
In patients with chronic kidney disease (CKD) receiving adequate erythropoietin therapy, the ideal dose of nandrolone decanoate (ND) to enhance muscle mass is not known.


METHODS
In this phase II dose-finding study, 54 patients with CKD stage 5 were randomized to either low, medium or high doses of ND (50, 100 or 200 mg/week for 24 weeks, respectively, in males; doses halved in females), while 7 patients acted as non-randomized controls. The primary outcome measure was appendicular lean mass (ALM) by dual-energy X-ray absorptiometry. Fluid overload (hydration of the fat-free mass) and indicators of physical functioning were secondary measures. Harms were also recorded. Data were analysed using Quade's (1967) non-parametric analysis of covariance.


RESULTS
ND increased ALM in a dose-responsive manner (change scores = 0.3 +/- 0.3 vs. 0.8 +/- 0.3 vs. 1.5 +/- 0.5 vs. 2.1 +/- 0.4 kg, control vs. low vs. medium vs. high dose groups, respectively, p < 0.001) with no increases in fluid overload but no consistent effect on physical functioning. The highest dose of ND (100 mg/week) was intolerable in females because of virilizing effects.


CONCLUSIONS
If goals of future studies are to improve body composition, dosing of ND up to 200 mg/week in males and 50 mg/week in females should be investigated. However, to realize improvements in physical functioning, future phase III trials of ND may require additional interventions such as exercise training.
Macdonald
Jamie H
JH
School of Sport, Health and Exercise Sciences, University of Wales-Bangor, Bangor, UK. j.h.macdonald@bangor.ac.uk
Marcora
Samuele M
SM
Jibani
Mahdi M
MM
Kumwenda
Mick J
MJ
Ahmed
Wasim
W
Lemmey
Andrew B
AB
D045930:Anabolic Agents / Q000008:administration & dosage*; D002908:Chronic Disease; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007674:Kidney Diseases / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D053580:Muscle Strength / Q000187:drug effects; D018482:Muscle, Skeletal / Q000187:drug effects / Q000503:physiopathology; D009277:Nandrolone / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077603:Nandrolone Decanoate; D016896:Treatment Outcome
D045930:Anabolic Agents; D009277:Nandrolone; D000077603:Nandrolone Decanoate