Methodology and Baseline Data of a Comparative Exploratory Double-Blinded Randomized Study of Intravenous Iron on Fibroblast Growth Factor 23 and Phosphate in Chronic Kidney Disease
Modern intravenous iron compounds (e.g., ferric carboxymaltose [FCM] and ferric derisomaltose [FDI]) are utilized in the treatment of iron deficiency anemia in non-dialysis-dependent chronic kidney disease (ND-CKD). Product-specific alterations in the metabolism of fibroblast growth factor 23 (FGF-2...
| Main Authors: | , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Karger Publishers
2023-05-01
|
| Series: | Kidney & Blood Pressure Research |
| Subjects: | |
| Online Access: | https://beta.karger.com/Article/FullText/528313 |
| _version_ | 1797797615354511360 |
|---|---|
| author | Xenophon Kassianides Sunil Bhandari |
| author_facet | Xenophon Kassianides Sunil Bhandari |
| author_sort | Xenophon Kassianides |
| collection | DOAJ |
| description | Modern intravenous iron compounds (e.g., ferric carboxymaltose [FCM] and ferric derisomaltose [FDI]) are utilized in the treatment of iron deficiency anemia in non-dialysis-dependent chronic kidney disease (ND-CKD). Product-specific alterations in the metabolism of fibroblast growth factor 23 (FGF-23) leading to hypophosphatemia have been described for certain intravenous iron compounds, such as FCM, with potential effects on bone and cardiovascular health and quality of life. No prior head-to-head comparison between FCM and FDI exists in ND-CKD. This single-center exploratory double-blind randomized controlled trial primarily aimed to investigate the differential impact of FCM and FDI on FGF-23 and phosphate in patients with iron deficiency +/− anemia and ND-CKD (stages 3a–5 – serum ferritin <200 μg/L or serum ferritin 200–299 μg/L and transferrin saturation <20%). Patients were randomized (1:1) to receive either FCM or FDI over two infusions (1 month apart). Follow-up was 3 months. Measurements of serum intact FGF-23, phosphate, vitamin D metabolites, parathyroid hormone, other bone metabolism, cardiovascular, and quality of life markers were monitored. 168 patients were prescreened. Thirty-five patients were screened; 26 patients were randomized. The mean (standard deviation) age was 67.9 (12.4) years and 17 participants were male. Most participants had stage 4 CKD (median [interquartile range] estimated glomerular filtration rate [eGFR]: 18.0 [11.3] mL/min/1.73 m2). A higher than normal median (interquartile range) level of intact FGF-23 (212.1 [116.4] pg/mL) was noted. Serum phosphate was within normal range, while parathyroid hormone was higher and 1,25 (OH)2 vitamin D lower than the normal range. The “Iron and Phosphaturia – ExplorIRON-CKD” trial will provide important information regarding the differential effect of intravenous iron products in terms of FGF-23, phosphate, and other markers of bone and cardiovascular metabolism, alongside patient-reported outcome measures in patients with ND-CKD. |
| first_indexed | 2024-03-13T03:51:02Z |
| format | Article |
| id | doaj.art-9d1770c5ba844b88ad1625c0e53e05aa |
| institution | Directory Open Access Journal |
| issn | 1420-4096 1423-0143 |
| language | English |
| last_indexed | 2024-03-13T03:51:02Z |
| publishDate | 2023-05-01 |
| publisher | Karger Publishers |
| record_format | Article |
| series | Kidney & Blood Pressure Research |
| spelling | doaj.art-9d1770c5ba844b88ad1625c0e53e05aa2023-06-22T13:45:56ZengKarger PublishersKidney & Blood Pressure Research1420-40961423-01432023-05-0148115116410.1159/000528313528313Methodology and Baseline Data of a Comparative Exploratory Double-Blinded Randomized Study of Intravenous Iron on Fibroblast Growth Factor 23 and Phosphate in Chronic Kidney DiseaseXenophon Kassianides0Sunil Bhandari1https://orcid.org/0000-0002-0996-9622Academic Renal Research Department, Hull University Teaching Hospitals NHS Trust and Hull York Medical School, Kingston upon Hull, UKAcademic Renal Research Department, Hull University Teaching Hospitals NHS Trust and Hull York Medical School, Kingston upon Hull, UKModern intravenous iron compounds (e.g., ferric carboxymaltose [FCM] and ferric derisomaltose [FDI]) are utilized in the treatment of iron deficiency anemia in non-dialysis-dependent chronic kidney disease (ND-CKD). Product-specific alterations in the metabolism of fibroblast growth factor 23 (FGF-23) leading to hypophosphatemia have been described for certain intravenous iron compounds, such as FCM, with potential effects on bone and cardiovascular health and quality of life. No prior head-to-head comparison between FCM and FDI exists in ND-CKD. This single-center exploratory double-blind randomized controlled trial primarily aimed to investigate the differential impact of FCM and FDI on FGF-23 and phosphate in patients with iron deficiency +/− anemia and ND-CKD (stages 3a–5 – serum ferritin <200 μg/L or serum ferritin 200–299 μg/L and transferrin saturation <20%). Patients were randomized (1:1) to receive either FCM or FDI over two infusions (1 month apart). Follow-up was 3 months. Measurements of serum intact FGF-23, phosphate, vitamin D metabolites, parathyroid hormone, other bone metabolism, cardiovascular, and quality of life markers were monitored. 168 patients were prescreened. Thirty-five patients were screened; 26 patients were randomized. The mean (standard deviation) age was 67.9 (12.4) years and 17 participants were male. Most participants had stage 4 CKD (median [interquartile range] estimated glomerular filtration rate [eGFR]: 18.0 [11.3] mL/min/1.73 m2). A higher than normal median (interquartile range) level of intact FGF-23 (212.1 [116.4] pg/mL) was noted. Serum phosphate was within normal range, while parathyroid hormone was higher and 1,25 (OH)2 vitamin D lower than the normal range. The “Iron and Phosphaturia – ExplorIRON-CKD” trial will provide important information regarding the differential effect of intravenous iron products in terms of FGF-23, phosphate, and other markers of bone and cardiovascular metabolism, alongside patient-reported outcome measures in patients with ND-CKD.https://beta.karger.com/Article/FullText/528313chronic kidney diseasemineral bone diseasefibroblast growth factor 23iron deficiency anemiaintravenous ironphosphate |
| spellingShingle | Xenophon Kassianides Sunil Bhandari Methodology and Baseline Data of a Comparative Exploratory Double-Blinded Randomized Study of Intravenous Iron on Fibroblast Growth Factor 23 and Phosphate in Chronic Kidney Disease Kidney & Blood Pressure Research chronic kidney disease mineral bone disease fibroblast growth factor 23 iron deficiency anemia intravenous iron phosphate |
| title | Methodology and Baseline Data of a Comparative Exploratory Double-Blinded Randomized Study of Intravenous Iron on Fibroblast Growth Factor 23 and Phosphate in Chronic Kidney Disease |
| title_full | Methodology and Baseline Data of a Comparative Exploratory Double-Blinded Randomized Study of Intravenous Iron on Fibroblast Growth Factor 23 and Phosphate in Chronic Kidney Disease |
| title_fullStr | Methodology and Baseline Data of a Comparative Exploratory Double-Blinded Randomized Study of Intravenous Iron on Fibroblast Growth Factor 23 and Phosphate in Chronic Kidney Disease |
| title_full_unstemmed | Methodology and Baseline Data of a Comparative Exploratory Double-Blinded Randomized Study of Intravenous Iron on Fibroblast Growth Factor 23 and Phosphate in Chronic Kidney Disease |
| title_short | Methodology and Baseline Data of a Comparative Exploratory Double-Blinded Randomized Study of Intravenous Iron on Fibroblast Growth Factor 23 and Phosphate in Chronic Kidney Disease |
| title_sort | methodology and baseline data of a comparative exploratory double blinded randomized study of intravenous iron on fibroblast growth factor 23 and phosphate in chronic kidney disease |
| topic | chronic kidney disease mineral bone disease fibroblast growth factor 23 iron deficiency anemia intravenous iron phosphate |
| url | https://beta.karger.com/Article/FullText/528313 |
| work_keys_str_mv | AT xenophonkassianides methodologyandbaselinedataofacomparativeexploratorydoubleblindedrandomizedstudyofintravenousirononfibroblastgrowthfactor23andphosphateinchronickidneydisease AT sunilbhandari methodologyandbaselinedataofacomparativeexploratorydoubleblindedrandomizedstudyofintravenousirononfibroblastgrowthfactor23andphosphateinchronickidneydisease |