Nandrolone decanoate as anabolic therapy in chronic kidney disease: a randomized phase II dose-finding study

Nephron Clin Pract. 2007;106(3):c125-35. doi: 10.1159/000103000. Epub 2007 May 22.


Background/aims: 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.

Conclusion: 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.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anabolic Agents / administration & dosage*
  • Chronic Disease
  • Dose-Response Relationship, Drug
  • Female
  • Humans
  • Kidney Diseases / drug therapy*
  • Kidney Diseases / physiopathology
  • Male
  • Middle Aged
  • Muscle Strength / drug effects
  • Muscle, Skeletal / drug effects
  • Muscle, Skeletal / physiopathology
  • Nandrolone / administration & dosage
  • Nandrolone / analogs & derivatives*
  • Nandrolone Decanoate
  • Treatment Outcome


  • Anabolic Agents
  • Nandrolone
  • Nandrolone Decanoate