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Vol. 106, No. 3, 2007
Issue release date: July 2007
Section title: Original Paper
Nephron Clin Pract 2007;106:c125–c135
(DOI:10.1159/000103000)

Nandrolone Decanoate as Anabolic Therapy in Chronic Kidney Disease: A Randomized Phase II Dose-Finding Study

Macdonald J.H. · Marcora S.M. · Jibani M.M. · Kumwenda M.J. · Ahmed W. · Lemmey A.B.
aSchool of Sport, Health and Exercise Sciences, University of Wales-Bangor, bRenal Unit, Ysbyty Gwynedd, Bangor, cRenal Unit, Ysbyty Glan Clwyd, Rhyl, and dRenal Unit, Ysbyty Wrexham Maelor, Wrexham, UK

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Article / Publication Details

First-Page Preview
Abstract of Original Paper

Received: 12/8/2006
Accepted: 3/5/2007
Published online: 5/22/2007

Number of Print Pages: 1
Number of Figures: 2
Number of Tables: 4

ISSN: (Print)
eISSN: 1660-2110 (Online)

For additional information: http://www.karger.com/NEC

Abstract

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.


Article / Publication Details

First-Page Preview
Abstract of Original Paper

Received: 12/8/2006
Accepted: 3/5/2007
Published online: 5/22/2007

Number of Print Pages: 1
Number of Figures: 2
Number of Tables: 4

ISSN: (Print)
eISSN: 1660-2110 (Online)

For additional information: http://www.karger.com/NEC


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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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