Long-term safety and efficacy of ferric citrate in phosphate-lowering and iron-repletion effects among patients with on hemodialysis: A multicenter, open-label, Phase IV trial.

Abstract

BACKGROUND:

We explored the long-term safety and efficacy of ferric citrate in hemodialysis patients in Taiwan, and further evaluated the iron repletion effect and change of iron parameters by different baseline groups.

METHODS:

This was a 12-month, Phase IV, multicenter, open-label study. The initial dose of ferric citrate was administered by patients' clinical condition and further adjusted to maintain serum phosphorus at 3.5-5.5 mg/dL. The primary endpoint was to assess the safety profiles of ferric citrate. The secondary endpoints were to evaluate the efficacy by the time-course changes and the number of subjects who achieved the target range of serum phosphorus.

RESULTS:

A total of 202 patients were enrolled. No apparent or unexpected safety concerns were observed. The most common treatment-emergent adverse events were gastrointestinal-related with discolored feces (41.6%). Serum phosphorus was well controlled, with a mean dose of 3.35±1.49 g/day, ranging from 1.5 to 6.0 g/day. Iron parameters were significantly improved. The change from baseline of ferritin and TSAT were 227.17 ng/mL and 7.53%, respectively (p-trend<0.001), and the increase started to slow down after 3-6 months of treatment. In addition, the increase trend was found only in patients with lower baseline level of ferritin (≤500 ng/mL) and TSAT (<30%).

CONCLUSIONS:

Ferric citrate is an effective phosphate binder with favorable safety profile in ESRD patients. The iron-repletion by ferric citrate is effective, and the increase is limited in patients with a higher baseline. In addition to controlling hyperphosphatemia, ferric citrate also shows additional benefits in the treatment of renal anemia.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov ID: NCT03256838; 12/04/2017.

• Authors: Chien-Te Lee, Chin-Chan Lee, Ming-Ju Wu, Yi-Wen Chiu, Jyh-Gang Leu, Ming-Shiou Wu, Yu-Sen Peng, Mai-Szu Wu, Der-Cherng Tarng
• Journal: PloS one (PLoS One) Vol. 17 Issue 3 Pg. e0264727 ( 2022) ISSN: 1932-6203 [Electronic] United States
• PMID: 35239732 (Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Ferric Compounds
• Phosphates
• Phosphorus
• ferric citrate
• Ferritins
• Iron

Topics

• Anemia, Iron-Deficiency (drug therapy)
• Ferric Compounds (adverse effects)
• Ferritins
• Humans
• Iron
• Phosphates
• Phosphorus
• Renal Dialysis (adverse effects)