Post-marketing observational study on Management of Anemia in Chronic Kidney Disease patients with WEPOX® Pen (MAP II)
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.
Conflict of Interest: Authors have no conflict of interest to declare
Funding Source: None declared.
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