Keryx Biopharmaceuticals Shares Results of Clinical Trial for Treating Patients with Advanced Chronic Kidney Disease with Ferric Citrate
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Details of the Clinical Study
The clinical trial was an open-label, single-center study that evaluated the use of ferric citrate in treating late-stage non-dialysis dependent CKD patients compared to the standard of care treatment (SOC). The clinical trial was conducted on patients who had an eGFR < 20 ml/min and who were not expected to start renal replacement therapy (dialysis) within 8 weeks of the start of the study. The patients were randomly segregated into two groups in the ratio of 2:1. One group received a fixed dose of ferric citrate (two tablets per meal), and the second group received SOC. A total of 199 patients were chosen for the study, of which 133 were treated with ferric citrate while the balance 66 patients were treated with SOC. Nearly 37% of the patients treated with SOC received phosphate binders during the pre-dialysis period. The patients who were a part of this trial were observed monthly for a nine-month period, whereas those patients who had started the dialysis treatment were observed three months after the start of dialysis. The data presented by the Company refers to the statistics from the non-dialysis period of the trial. This includes those patients who were observed for nine months and did not progress to dialysis or the time leading up to dialysis for patients who progressed.
Results of the Clinical Study
While analyzing the data from the clinical trial, the Company used many biochemical parameters associated with CKD, viz., hemoglobin, transferrin saturation (TSAT), ferritin, phosphorus, and intact-FGF23 in all the enrolled patients. At baseline, these parameters were consistent between the treatment groups. However, there were more diabetic patients who were randomly assigned to receive the SOC treatment.
Out of the 133 patients who were chosen to receive ferric citrate treatment, 76 patients completed the full nine months of the study; 30 patients started renal replacement therapy; 16 patients terminated early; 8 patients received a transplant; and 3 patients died.
In the 66 patients’ group that received SOC treatment, 29 patients completed the nine months of the study; 31 patients started renal replacement therapy; 4 patients terminated early; and 2 patients died.
At the end of the nine months of the clinical trial, patients who had received the ferric citrate during the non-dialysis period showed significant improvements across all biochemical parameters of the trial compared to those patients who were treated with SOC. Overall, when comparing the patients progress towards death, dialysis, or transplant in each treatment scenario, it was noticed that patients who were treated with ferric citrate were less likely to reach dialysis or death.
Commenting on the results of the clinical study, Geoffrey Block, M.D, Director of Clinical Research at Denver Nephrology, said: