Kidney Week

Abstract: TH-PO171

A Postmarketing Study Assessing Safety and Efficacy of Velphoro in Korean Adult Dialysis Patients

Session Information

• CKD-MBD: Clinical
  October 24, 2024 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Bone and Mineral Metabolism

• 502 Bone and Mineral Metabolism: Clinical

Authors

• Qi, Weiwei, Fresenius Medical Care Shanghai Co Ltd, Shanghai, Shanghai, China

Weiwei Qi, PhD

• Hwang, Won Min, Konyang University Hospital, Daejeon, Korea (the Republic of)

Won Min Hwang, MD, PhD

• Ahn, Shin-Young, Korea University Guro Hospital, Guro-gu, Seoul, Korea (the Republic of)

Shin-Young Ahn, MD, PhD

• Lee, Young-Ki, Hallym University Kangnam Sacred Heart Hospital, Yeongdeungpo-gu, Seoul, Korea (the Republic of)

Young-Ki Lee, MD, PhD

• Shin, Byung Chul, Chosun University Hospital, Gwangju, Korea (the Republic of)

Byung Chul Shin

• Lee, Jong hoon, Gimpo Woori hospital, Seoul, Korea (the Republic of)

Jong hoon Lee, MD

• Kim, Seon Gun, Fresenius Medical Care Korea Ltd, Seoul, Korea (the Republic of)

Seon Gun Kim

• Kim, Hye-Jung, Fresenius Medical Care Korea Ltd, Seoul, Korea (the Republic of)

Hye-Jung Kim

• Stauss-Grabo, Manuela, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany

Manuela Stauss-Grabo, PhD

• So, Carmen, Fresenius Medical Care Asia Pacific Ltd, Hong Kong, Hong Kong

Carmen So, MSc

• Feuersenger, Astrid, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany

Astrid Feuersenger

Background

Hyperphosphatemia is a frequent sequalae of chronic kidney disease and often requires phosphate binders to control. Velphoro® (calcium-free polynuclear iron (III)-oxyhydroxide phosphate binder, Vifor Fresenius Medical Care Renal Pharma Ltd., Switzerland) is a chewable tablet and had been approved in adult dialysis patients in Europe and the US since 2013 and in Korea since 2018. As clinical trials may not reflect real-world use of medications, we performed a post-marketing study (PMS) to monitor the safety profile of Velphoro® in Korea.

Methods

We conducted a non-interventional, prospective PMS in 647 dialysis patients from 18 sites with a 6-week short term and 24-week long term observation. Subjects enrolled in this study should newly receive Velphoro® for up to 1 week. Both safety and efficacy information were observed.

Results

A total of 596 subjects finished short-term observation and were included in safety analysis. Of these, 82 subjects finished the long-term observation.
For short-term cohort, 284 adverse events (AE) and 91 adverse drug reactions (ADR) were reported. Gastrointestinal (GI) disorders were the most common ADR reported at 10.91% mainly diarrhea (5.37%). 27 serious AEs were reported but none of them was serious ADR. Besides, unexpected ADRs were reported for 15 cases mainly GI disorders, and none was severe.
The 82 subjects who comprised the long-term cohort reported 46 AEs and 3 of them were ADR. None of the ADR was serious but 2 were reported as unexpected which were chest pain and abdominal discomfort.
For iron test, a small increase in ferritin was observed at week 6 (351.51±286.99ng/ml) and week 24 (420.82±325.74ng/ml) while only an increase trend at week 6 (35.65±17.38%) but no further increase was observed at week 24 (38.05±15.11%) in TSAT level.
For serum phosphorus control, the average serum phosphorus reduction at week 6 was -0.97±1.6 mg/dl while at week 24 from baseline was -0.82±1.48mg/dl.

Conclusion

In this PMS, GI disorders were the main ADR. No obvious iron accumulation was observed. In conclusion, Velphoro® has a favourable safety and tolerability profile in Korean patients that is consistent with that observed in Phase 3 trial (PA-CL-05A).

Funding

• Commercial Support – Fresenius Medical Care