The Indian Practitioner

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

Post-Marketing Observational Study on Management of Anemia in Chronic Kidney Disease patients with WEPOX® Pen (MAP II)


Affiliations
1 Max Balaji Hospital, Patparganj, Delhi, India
2 Fortis Hospital, Mulund West, Mumbai, India
3 Asian Institute of Medical Sciences, Faridabad, Haryana, India
4 Sundaram Medical Foundation, Anna Nagar, Chennai, India
5 Trichy SRM Medical College Hospital and Research Centre, Tiruchirapalli, TN, India
6 Wockhardt Medical Affairs, Bandra Kurla Complex, Mumbai, India
     

   Subscribe/Renew Journal


Objective: To evaluate effectiveness and safety of WEPOX® Pen, a pre-calibrated pen device loaded with 30,000 IU cartridge of recombinant human EPO (rHuEPO), in management of anemia in CKD patients, in the real-world clinical settings.

Material and Methods: In this prospective, multi-center, open-label, post marketing surveillance study, ambulatory pediatric and adult patients of either gender, diagnosed with CKD and anemia were enrolled to access the effectiveness and safety of WEPOX® Pen. Patients were divided in two groups based on baseline Hb (g/dL) levels; Hb<10g/dL (Group 1) and Hb≥10g/dL (Group 2). Results were recorded in the follow up visits scheduled at weeks 5, and 12. Investigator had the choice to discontinue the patient from the study as per his/ her discretion based on significant adverse drug reaction or lack of expected effectiveness.

Results: A total of 409 patients were enrolled in the study; out of which 377 (92.2%) patients were enrolled in Group 1 and 32 (7.8%) patients in Group 2. Proportion of patients in Group 1 achieving ≥1 g/dL rise in Hb value from baseline were 70.3% and 86.5% at week 5 and 12, respectively. Similarly, proportion of patients in group 2 maintaining Hb levels of ≥10 g/dL were 68.7% and 96.8% at week 5 and 12 respectively. Overall compared to baseline, Hb (g/dL) levels increased in 366 (97.1%) and 30 (93.8%) patients, in group 1 and 2 respectively, at 12-weeks. No adverse events were reported during the study duration.

Conclusion: Treatment with WEPOX® Pen (rHuEPO Injection) in CKD patients with anemia was well tolerated and produced a clinically relevant improvement in Hb levels.


Keywords

Anemia, Chronic Kidney Disease, Erythropoietin Pen Device, Hemoglobin, Erythropoietin Stimulating Agent (ESA).
Subscription Login to verify subscription
User
Notifications
Font Size


  • Varughese S, Abraham G. Chronic Kidney Disease in India: A Clarion Call for Change. Clin J Am SocNephrol. 2018; 13:802-804.

  • Singh AK, Farag YM, Mittal BV, Subramanian KK, Reddy SR, Acharya VN, et al. Epidemiology and risk factors of chronic kidney disease in India - results from the SEEK (Screening and Early Evaluation of Kidney Disease) study. BMC Nephrol. 2013;14:114. doi: 10.1186/1471-2369-14-114

  • Varma PP. Prevalence of chronic kidney disease in India Where are we heading? Indian J Nephrol. 2015; 25:133-5.

  • Babitt JL, Lin HY. Mechanisms of anemia in CKD. J Am SocNephrol. 2012; 23:1631-4.

  • Weil EJ, Curtis JM, Hanson RL, Knowler WC, Nelson RG. The impact of disadvantage on the development and progression of diabetic kidney disease. Clin Nephrol 2010; 74:32-38.

  • Barkate H, Motlekar S, Rao S, Kamble S. Assessment of Patient Perceptions about Use of WepoxPenTM (Recombinant Erythropoietin Delivery Device with 30, 000 IU Cartridge) in the Management of Anemia in Chronic Kidney Disease Patients. Open Journal of Nephrology 2017; 7:38-46.

  • Sarkar J, Potdar AA, Saidel GM. Whole-body iron transport and metabolism: Mechanistic, multi-scale model to improve treatment of anemia in chronic kidney disease. PLoS Comput Biol. 2018; 14(4):e1006060.

  • Xu Y, Peng H, Ke B. α-klotho and anemia in patients with chronic kidney disease patients: A new perspective. ExpTher Med. 2017; 14:5691-5695.

  • Aapro M, Gascón P, Patel K, Rodgers GM, Fung S, Arantes LH Jr, et al. Erythropoiesis-Stimulating Agents in the Management of Anemia in Chronic Kidney Disease or Cancer: A Historical Perspective. Front Pharmacol. 2019; 9:1498. doi:10.3389/fphar.2018.01498.

  • Robles NR. The Safety of Erythropoiesis-Stimulating Agents for the Treatment of Anemia Resulting from Chronic Kidney Disease. Clin Drug Investig. 2016; 36:421-31.

  • Provatopoulou ST, Ziroyiannis PN. Clinical use of erythropoietin in chronic kidney disease: outcomes and future prospects. Hippokratia. 2011; 15:109-15.

  • Fujiwara N, Nakamura T, Sato E, Kawagoe Y, Hikichi Y, Ueda Y, et al. Renovascular protective effects of erythropoietin in patients with chronic kidney disease. Intern Med. 2011; 50:1929-34.

  • Barkate H., Motlekar S., Rao S., Kamble S. Assessment of Patient Perceptions about Use of WepoxPenTM (Recombinant Erythropoietin Delivery Device with 30,000 IU Cartridge) in the Management of Anemia in Chronic Kidney Disease Patients. Open Journal of Nephrology. 2017; 7:38-46.DOI:https://doi.org/10.4236/ojneph.2017.72005

  • Babitt JL, Lin HY. Mechanisms of Anemia in CKD. JASN. 2012; 23:1631-1634; DOI: https://doi.org/10.1681/ASN.2011111078

  • Eschbach JW. The anemia of chronic renal failure: pathophysiology and the effects of recombinant erythropoietin. Kidney Int. 1989; 35:134-48.

  • Winearls CG, Oliver DO, Pippard MJ, Reid C, Downing MR, Cotes PM. Effect of human erythropoietin derived from recombinant DNA on the anaemia of patients maintained by chronic haemodialysis. Lancet. 1986; 2:1175-8.

  • Eschbach JW, Egrie JC, Downing MR, Browne JK, Adamson JW.Correction of the anemia of end-stage renal disease with recombinant human erythropoietin. Results of a combined phase I and II clinical trial. N Engl J Med. 1987; 316:73-8.

  • Pappas KD, Gouva CD, Katopodis KP, Nikolopoulos PM, Korantzopoulos PG, Michalis LK, et al. Correction of anemia with erythropoietin in chronic kidney disease (stage 3 or 4): effects on cardiac performance. Cardiovasc Drugs Ther. 2008; 22:37-44.

  • National Kidney Foundation, KDOQI (2001) IV. NKF-K/DOQI Clinical Practice Guidelines for Anemia of Chronic Kidney Disease: update 2000. Am J Kidney Dis 37: S182-238.

  • Kristal B, Shurtz-Swirski R, Tanhilevski O, Shapiro G, Shkolnik G, Chezar J, et al. Epoetin-alpha: preserving kidney function via attenuation of polymorphonuclear leukocyte priming. Isr Med Assoc J. 2008; 10:266-72.

  • Schärer K, Klare B, Braun A, Dressel P, Gretz N. Treatment of renal anemia by subcutaneous erythropoietin in children with preterminal chronic renal failure. Acta Paediatr. 1993; 82:953-8.

  • Cody JD, Hodson EM. Recombinant human erythropoietin versus placebo or no treatment for the anaemia of chronic kidney disease in people not requiring dialysis. Cochrane Database Syst Rev. 2016; (1):CD003266. doi: 10.1002/14651858.CD003266.pub3.

  • Debska-Slizień A, Owczarzak A, Lysiak-Szydłowska W, Rutkowski B. Erythrocyte metabolism during renal anemia treatment with recombinant human erythropoietin. Int J Artif Organs. 2004; 27:935-42.

  • Mohammadpour AH, Nazemian F, Khaiat MH, Tafaghodi M, Salari P, Charkazi S, et al. Evaluation of the effect of pentoxifylline on erythropoietin-resistant anemia in hemodialysis patients. Saudi J Kidney Dis Transpl. 2014; 25:73-8.

  • Painter P, Moore G, Carlson L, Paul S, Myll J, Phillips W, Haskell W: Effects of exercise training plus normalization of hematocrit on exercise capacity and health-related quality of life. Am J Kidney Dis. 2002; 39: 257-265.

  • Valderrábano F, Jofre R, López-Gómez JM.Quality of life in end-stage renal disease patients. Am J Kidney Dis. 2001; 38:443-64.

  • O’Mara NB. Anemia in Patients With Chronic Kidney Disease. Diabetes Spectr. 2008; 21:12-19.

  • Pisoni RL, Bragg-Gresham JL, Young EW, Akizawa T, Asano Y, Locatelli F, et al. Anemia management and outcomes from 12 countries in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis. 2004; 44:94-111.

  • Provatopoulou ST, Ziroyiannis PN. Clinical use of erythropoietin in chronic kidney disease: outcomes and future prospects. Hippokratia. 2011; 15:109-15.

  • Bahlmann FH, Kielstein JT, Haller H, Fliser D. Erythropoietin and progression of CKD. Kidney Int Suppl. 2007; 107:S21-5.

  • Bahlmann FH, Fliser D. Erythropoietin and renoprotection. Curr Opin Nephrol Hypertens. 2009; 18:15-20.


Abstract Views: 306

PDF Views: 1




  • Post-Marketing Observational Study on Management of Anemia in Chronic Kidney Disease patients with WEPOX® Pen (MAP II)

Abstract Views: 306  |  PDF Views: 1

Authors

Dilip Bhalla
Max Balaji Hospital, Patparganj, Delhi, India
Raman Malik
Fortis Hospital, Mulund West, Mumbai, India
Reetesh Sharma
Asian Institute of Medical Sciences, Faridabad, Haryana, India
M. Sivalingam
Sundaram Medical Foundation, Anna Nagar, Chennai, India
Subrahmanian Sathiavageesan
Trichy SRM Medical College Hospital and Research Centre, Tiruchirapalli, TN, India
Sanjay Kamble
Wockhardt Medical Affairs, Bandra Kurla Complex, Mumbai, India
Shahu Ingole
Wockhardt Medical Affairs, Bandra Kurla Complex, Mumbai, India
Rishi Jain
Wockhardt Medical Affairs, Bandra Kurla Complex, Mumbai, India

Abstract


Objective: To evaluate effectiveness and safety of WEPOX® Pen, a pre-calibrated pen device loaded with 30,000 IU cartridge of recombinant human EPO (rHuEPO), in management of anemia in CKD patients, in the real-world clinical settings.

Material and Methods: In this prospective, multi-center, open-label, post marketing surveillance study, ambulatory pediatric and adult patients of either gender, diagnosed with CKD and anemia were enrolled to access the effectiveness and safety of WEPOX® Pen. Patients were divided in two groups based on baseline Hb (g/dL) levels; Hb<10g/dL (Group 1) and Hb≥10g/dL (Group 2). Results were recorded in the follow up visits scheduled at weeks 5, and 12. Investigator had the choice to discontinue the patient from the study as per his/ her discretion based on significant adverse drug reaction or lack of expected effectiveness.

Results: A total of 409 patients were enrolled in the study; out of which 377 (92.2%) patients were enrolled in Group 1 and 32 (7.8%) patients in Group 2. Proportion of patients in Group 1 achieving ≥1 g/dL rise in Hb value from baseline were 70.3% and 86.5% at week 5 and 12, respectively. Similarly, proportion of patients in group 2 maintaining Hb levels of ≥10 g/dL were 68.7% and 96.8% at week 5 and 12 respectively. Overall compared to baseline, Hb (g/dL) levels increased in 366 (97.1%) and 30 (93.8%) patients, in group 1 and 2 respectively, at 12-weeks. No adverse events were reported during the study duration.

Conclusion: Treatment with WEPOX® Pen (rHuEPO Injection) in CKD patients with anemia was well tolerated and produced a clinically relevant improvement in Hb levels.


Keywords


Anemia, Chronic Kidney Disease, Erythropoietin Pen Device, Hemoglobin, Erythropoietin Stimulating Agent (ESA).

References