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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
     

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

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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