SO050DIFFERENT FERRIC CITRATE DOSE REGIMENS IN THE TREATMENT OF IRON DEFICIENCY ANAEMIA IN PATIENTS WITH NON-DIALYSIS-DEPENDENT CKD: THE COMPASS TRIAL
| Autor: | Diogo Belo, Paul W Crawford, Pablo E. Pergola, Moustafa Moustafa, Alexander Goldfarb-Rumyantezev, Dennis Vargo, Wenli Luo |
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| Rok vydání: | 2020 |
| Předmět: |
Transplantation
medicine.medical_specialty biology business.industry Anemia medicine.medical_treatment Iron deficiency medicine.disease Gastroenterology Ferritin Hyperphosphatemia Regimen Iron-deficiency anemia Nephrology Internal medicine Diabetes mellitus medicine biology.protein Hemodialysis business |
| Zdroj: | Nephrology Dialysis Transplantation. 35 |
| ISSN: | 1460-2385 0931-0509 |
| Popis: | Background and Aims Ferric citrate (FC) is approved in the US as oral iron replacement for the treatment of iron deficiency anaemia (IDA) in adult patients with non-dialysis dependent (NDD) chronic kidney disease (CKD) and for the treatment of hyperphosphatemia in adult patients with dialysis dependent CKD. For IDA, a starting dose FC of 1 tablet three times daily (TID) is recommended with titration to maintain haemoglobin (Hb) at goal. This study was designed to investigate the possibility of dosing FC twice daily (BID) for flexibility in clinical practice. The efficacy and safety of different FC dosing regimens for the treatment of IDA were examined in adults with NDD-CKD. Method In this 48-wk, Phase 4, randomized, open-label, multicentre study, subjects with IDA of NDD-CKD (stage 3-5) were randomized 1:1 to receive 1 FC tablet (1gm containing 210mg ferric iron) TID or 2 tablets BID. At wk 12, subjects whose Hb increased Results 206 subjects were randomized, 183 were included in this analysis after completing the 24-wk dose titration period. Groups were well matched with mean age of 69.5 +/- 10.32 years, 64% female and 54% had diabetes as a cause of CKD. Mean BL eGFR was 33.6 +/- 10.85 ml/min/1.73m2 and Hb 10.45 +/-0.744 g/dL. In subjects who did not require an increase in the FC dose at wk 12, mean changes in Hb at wk 24 were 1.05 and 1.24 g/dL in the 1 tablet TID and 2 tablet BID dosage groups, respectively. In subjects who required an increase in the FC dose at wk 12, mean changes in Hb at wk 24 were 0.41 and 0.13 g/dL in the 2 tablet TID and 3 tablet BID groups, respectively. Mean changes in TSAT, ferritin and phosphate are presented in the Table. The incidence of TEAEs was 78.2% and 75.0% in the BID and TID groups, respectively. The most common AEs reported were diarrhoea, stool discoloration and constipation. The incidence of SAEs was 13.9% and 17.3% in the BID and TID groups, respectively. Five deaths were reported, none were deemed related to FC per the investigator. Conclusion FC was effective and generally well tolerated in the treatment of IDA in this NDD-CKD population. Subjects who had per protocol FC dose increases at wk 12 had less pronounced iron deficiency at BL and smaller increases in Hb suggesting an additional underlying cause of anaemia. Mean changes in Hb, TSAT, ferritin, and phosphate and AE profiles were similar in the BID and TID regimens as well as in 3 g/day and 4 g/day dosing groups supporting the potential for dosing flexibility with FC. Clinicaltrials.gov identifier NCT03236246 Funding provided by Akebia Therapeutics, Inc. |
| Databáze: | OpenAIRE |
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