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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


Copyright / Drug Dosage

Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher or, in the case of photocopying, direct payment of a specified fee to the Copyright Clearance Center.
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.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

References

  1. Woodrow G, Oldroyd B, Turney JH, Tompkins L, Brownjohn AM, Smith MA: Whole body and regional body composition in patients with chronic renal failure. Nephrol Dial Transplant 1996;11:1613–1618.
  2. Macdonald JH, Phanish MK, Marcora SM, Jibani M, Bloodworth LL, Holly JM, Lemmey AB: Muscle insulin-like growth factor status, body composition, and functional capacity in hemodialysis patients. J Ren Nutr 2004;14:248–252.
  3. Johansen KL, Shubert T, Doyle J, Soher B, Sakkas GK, Kent-Braun JA: Muscle atrophy in patients receiving hemodialysis: effects on muscle strength, muscle quality, and physical function. Kidney Int 2003;63:291–297.
  4. Painter P, Carlson L, Carey S, Paul SM, Myll J: Physical functioning and health-related quality-of-life changes with exercise training in hemodialysis patients. Am J Kidney Dis 2000;35:482–492.
  5. Ikizler TA, Wingard RL, Harvell J, Shyr Y, Hakim RM: Association of morbidity with markers of nutrition and inflammation in chronic hemodialysis patients: a prospective study. Kidney Int 1999;55:1945–1951.
  6. Kato A, Odamaki M, Yamamoto T, Yonemura K, Maruyama Y, Kumagai H, Hishida A: Influence of body composition on 5 year mortality in patients on regular haemodialysis. Nephrol Dial Transplant 2003;18:333–340.
  7. Sheashaa H, Abdel-Razek W, El Husseini A, Selim A, Hassan N, Abbas T, El Askalani H, Sobh M: Use of nandrolone decanoate as an adjuvant for erythropoietin dose reduction in treating anemia in patients on hemodialysis. Nephron Clin Pract 2005;99:c102–c106.

    External Resources

  8. Navarro JF, Mora C: In-depth review effect of androgens on anemia and malnutrition in renal failure: implications for patients on peritoneal dialysis. Perit Dial Int 2001;21:14–24.
  9. Barton PA, Chretien C, Lau AH: The effects of nandrolone decanoate on nutritional parameters in hemodialysis patients. Clin Nephrol 2002;58:38–46.

    External Resources

  10. Dombros NV, Digenis GE, Soliman G, Oreopoulos DG: Anabolic steroids in the treatment of malnourished CAPD patients: a retrospective study. Perit Dial Int 1994;14:344–347.
  11. Gascon A, Belvis JJ, Berisa F, Iglesias E, Estopinan V, Teruel JL: Nandrolone decanoate is a good alternative for the treatment of anemia in elderly male patients on hemodialysis. Geriatr Nephrol Urol 1999;9:67–72.
  12. Kim MJ: Effects of anabolic steroids on nutritional parameters in malnourished CAPD patients (abstract). J Am Soc Nephrol 1997;8:266.
  13. Johansen KL, Mulligan K, Schambelan M: Anabolic effects of nandrolone decanoate in patients receiving dialysis: a randomized controlled trial. JAMA 1999;281:1275–1281.
  14. Johansen KL, Painter PL, Sakkas GK, Gordon P, Doyle J, Shubert T: Effects of resistance exercise training and nandrolone decanoate on body composition and muscle function among patients who receive hemodialysis: a randomized, controlled trial. J Am Soc Nephrol 2006;17:2307–2314.
  15. McLeod I: Remark AS R58. A remark on algorithm AS 183. An efficient and portable pseudo-random number generator. Appl Statist 1985;34:198–200.

    External Resources

  16. Wichmann B, Hill I: Algorithm AS 183. An efficient and portable pseudo-random number generator. Appl Statist 1982;31:188–190.

    External Resources

  17. Kim J, Wang Z, Heymsfield SB, Baumgartner RN, Gallagher D: Total-body skeletal muscle mass: estimation by a new dual-energy X-ray absorptiometry method. Am J Clin Nutr 2002;76:378–383.
  18. Macdonald JH, Marcora SM, Jibani M, Phanish MK, Holly J, Lemmey AB: Intradialytic exercise as anabolic therapy in haemodialysis patients – a pilot study. Clin Physiol Funct Imaging 2005;25:113–118.
  19. Rikli R, Jones C: Senior Fitness Test Manual. Champaign/IL, Human Kinetics, 2001.
  20. Ioannidis JP, Evans SJ, Gotzsche PC, O’Neill RT, Altman DG, Schulz K, Moher D: Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004;141:781–788.
  21. Bonate PL: Analysis of Pretest-Postest Designs. Boca Raton, Chapman & Hall/CRC, 2000.
  22. Ludbrook J: Multiple comparison procedures updated. Clin Exp Pharmacol Physiol 1998;25:1032–1037.
  23. Bausell R, Li Y: Power Analysis for Experimental Research. Cambridge, Cambridge University Press, 2002.
  24. Maisonneuve P, Agodoa L, Gellert R, Stewart JH, Buccianti G, Lowenfels AB, Wolfe RA, Jones E, Disney AP, Briggs D, McCredie M, Boyle P: Distribution of primary renal diseases leading to end-stage renal failure in the USA, Europe, and Australia/New Zealand: results from an international comparative study. Am J Kidney Dis 2000;35:157–165.
  25. Forbes GB: The effect of anabolic steroids on lean body mass: the dose-response curve. Metabolism 1985;34:571–573.
  26. Bhasin S, Woodhouse L, Casaburi R, Singh AB, Bhasin D, Berman N, Chen X, Yarasheski KE, Magliano L, Dzekov C, Dzekov J, Bross R, Phillips J, Sinha-Hikim I, Shen R, Storer TW: Testosterone dose-response relationships in healthy young men. Am J Physiol 2001;281:E1172–E1181.
  27. Bhasin S, Woodhouse L, Casaburi R, Singh AB, Mac RP, Lee M, Yarasheski KE, Sinha-Hikim I, Dzekov C, Dzekov J, Magliano L, Storer TW: Older men are as responsive as young men to the anabolic effects of graded doses of testosterone on the skeletal muscle. J Clin Endocrinol Metab 2005;90:678–688.
  28. Pupim LB, Alp IT: Uremic malnutrition: new insights into an old problem. Semin Dial 2003;16:224–232.
  29. Johansen KL: Testosterone metabolism and replacement therapy in patients with end-stage renal disease. Semin Dial 2004;17:202–208.
  30. Beddhu S, Pappas LM, Ramkumar N, Samore M: Effects of body size and body composition on survival in hemodialysis patients. J Am Soc Nephrol 2003;14:2366–2372.
  31. Charra B, Chazot C: Volume control, blood pressure and cardiovascular function. Lessons from hemodialysis treatment. Nephron Physiol 2003;93:94–101.
  32. Storer TW, Magliano L, Woodhouse L, Lee ML, Dzekov C, Dzekov J, Casaburi R, Bhasin S: Testosterone dose-dependently increases maximal voluntary strength and leg power, but does not affect fatigability or specific tension. J Clin Endocrinol Metab 2003;88:1478–1485.
  33. Snyder PJ, Peachey H, Hannoush P, Berlin JA, Loh L, Lenrow DA, Holmes JH, Dlewati A, Santanna J, Rosen CJ, Strom BL: Effect of testosterone treatment on body composition and muscle strength in men over 65 years of age. J Clin Endocrinol Metab 1999;84:2647–2653.
  34. Schroeder ET, Terk M, Sattler FR: Androgen therapy improves muscle mass and strength but not muscle quality: results from two studies. Am J Physiol 2003;285:E16–E24.
  35. Gayan-Ramirez G, Rollier H, Vanderhoydonc F, Verhoeven G, Gosselink R, Decramer M: Nandrolone decanoate does not enhance training effects but increases IGF-I mRNA in rat diaphragm. J Appl Physiol 2000;88:26–34.
  36. Doane BD, Fried W, Schwartz F: Response of uremic patients to nandrolone decanoate. Arch Intern Med 1975;135:972–975.
  37. Cohn L, Feller AG, Draper MW, Rudman IW, Rudman D: Carpal tunnel syndrome and gynaecomastia during growth hormone treatment of elderly men with low circulating IGF-I concentrations. Clin Endocrinol (Oxf) 1993;39:417–425.
  38. Besarab A, Bolton WK, Browne JK, Egrie JC, Nissenson AR, Okamoto DM, Schwab SJ, Goodkin DA: The effects of normal as compared with low hematocrit values in patients with cardiac disease who are receiving hemodialysis and epoetin. N Engl J Med 1998;339:584–590.
  39. Garrancho JM, Kirchgessner J, Arranz M, Klinkner G, Rentero R, Ayala JA, Marcelli D: Haemoglobin level and vascular access survival in haemodialysis patients. Nephrol Dial Transplant 2005;20:2453–2457.
  40. Bhasin S: Testosterone supplementation for aging-associated sarcopenia. J Gerontol A Biol Sci Med Sci 2003;58:1002–1008.
  41. Du Bois D, Du Bois EF: A formula to estimate the approximate surface area if height and weight are known. Arch Intern Med 1916;17:863–871.