Kidney Week

Abstract: FR-PO243

A Randomized Trial of Ferric Citrate in Advanced CKD: Safety

Session Information

• CKD: Clinical, Outcomes, Trials - II
  October 26, 2018 | Location: Exhibit Hall, San Diego Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: CKD (Non-Dialysis)

• 1902 CKD (Non-Dialysis): Clinical, Outcomes, and Trials

Authors

• Block, Geoffrey A., Colorado Kidney Care, Denver, Colorado, United States

Geoffrey A. Block,

• Persky, Martha, Denver Nephrology Research Division, Denver, Colorado, United States

Martha Persky,

• Mehta, Rupal, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, United States

Rupal Mehta,

• Isakova, Tamara, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, United States

Tamara Isakova,

• Wolf, Myles, Duke University, Durham, North Carolina, United States

Myles Wolf,

• Chertow, Glenn Matthew, Stanford University School of Medicine, Palo Alto, California, United States

Glenn Matthew Chertow,

Background

We hypothesized that provision of fixed dose ferric citrate (FC), independent of serum phosphate (P) or degree of anemia, would improve multiple biochemical manifestations of advanced chronic kidney disease and reduce associated complications.

Methods

Patients with eGFR ≤ 20 ml/min (50% eGFR ≤ 15 ml/min), P ≥3.0 mg/dL, hemoglobin (Hb) >8.0 g and who were not anticipated to start dialysis within 8 weeks were randomized 2:1 to received fixed dose FC, (two per meal) or standard of care treatment (SOC). 199 patients (133 FC, 66 SOC) attended at least 1 follow-up visit. Patients were seen monthly for 9 months, or, for individuals who started hemo- or peritoneal dialysis, for 3 months thereafter.

Results

Baseline characteristics were similar with the exception of diabetes, which was more common in the SOC arm. Mean baseline eGFR was 14 ml/min.
Table 1 shows the proportion of patients with any AE and serious AEs by treatment arm.
“Gastrointestinal” (GI) was the only SOC in which related AE’s occurred in ≥ 5% of FC patients: discolored feces (28%), constipation (12%) and diarrhea (9%). No related serious adverse events occurred.
Annualized admission rates were lower with FC than with SOC (median (10%, 90% range), 0 (0,1.9) versus 0 (0,5.2), Wilcoxon Rank Sum p=0.001). After adjusting for age, race, sex, baseline eGFR and diabetes, treatment with FC significantly reduced hospital admissions (p=0.002) and hospital days (p=0.0006).

Conclusion

In this randomized, unblinded trial in patients with advanced CKD, treatment with fixed-dose FC resulted in an increase in GI AEs and a reduction in annualized hospital admission rates and hospital days. Larger, placebo-controlled trials of FC in this patient population are warranted to determine the reproducibility of these findings.

Funding

• Commercial Support –