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Dose-response and efficacy of ferric citrate to treat hyperphosphatemia in hemodialysis patients: a short-term randomized trial.
Am J Kidney Dis. 2013 May; 61(5):759-66.AJ

Abstract

BACKGROUND

Most dialysis patients require phosphate binders to control hyperphosphatemia. Ferric citrate has been tested in phase 2 trials as a phosphate binder. This trial was designed as a dose-response and efficacy trial.

STUDY DESIGN

Prospective, phase 3, multicenter, open-label, randomized clinical trial.

SETTING & PARTICIPANTS

151 participants with hyperphosphatemia on maintenance hemodialysis therapy.

INTERVENTION

Fixed dose of ferric citrate taken orally as a phosphate binder for up to 28 days (1, 6, or 8 g/d in 51, 52, and 48 participants, respectively).

OUTCOMES

Primary outcome is dose-response of ferric citrate on serum phosphorus level; secondary outcomes are safety and tolerability.

MEASUREMENTS

Serum chemistry tests including phosphorus, safety data.

RESULTS

151 participants received at least one dose of ferric citrate. Mean baseline phosphorus levels were 7.3 ± 1.7 (SD) mg/dL in the 1-g/d group, 7.6 ± 1.7 mg/dL in the 6-g/d group, and 7.5 ± 1.6 mg/dL in the 8-g/d group. Phosphorus levels decreased in a dose-dependent manner (mean change at end of treatment, -0.1 ± 1.3 mg/dL in the 1-g/d group, -1.9 ± 1.7 mg/dL in the 6-g/d group, and -2.1 ± 2.0 mg/dL in the 8-g/d group). The mean difference in reduction in phosphorus levels between the 6- and 1-g/d groups was 1.3 mg/dL (95% CI, 0.69 to 1.9; P < 0.001), between the 8- and 1-g/d groups was 1.5 mg/dL (95% CI, 0.86 to 2.1; P < 0.001), and between the 8- and 6-g/d groups was 0.21 mg/dL (95% CI, -0.39 to 0.81; P = 0.5). The most common adverse event was stool discoloration.

LIMITATIONS

Sample size and duration confirm efficacy, but limit our ability to confirm safety.

CONCLUSIONS

Ferric citrate is efficacious as a phosphate binder in a dose-dependent manner. A phase 3 trial is ongoing to confirm safety and efficacy.

Authors+Show Affiliations

Division of Nephrology and Hypertension, Vanderbilt University Medical Center, Nashville, TN 37232, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23369827

Citation

Dwyer, Jamie P., et al. "Dose-response and Efficacy of Ferric Citrate to Treat Hyperphosphatemia in Hemodialysis Patients: a Short-term Randomized Trial." American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation, vol. 61, no. 5, 2013, pp. 759-66.
Dwyer JP, Sika M, Schulman G, et al. Dose-response and efficacy of ferric citrate to treat hyperphosphatemia in hemodialysis patients: a short-term randomized trial. Am J Kidney Dis. 2013;61(5):759-66.
Dwyer, J. P., Sika, M., Schulman, G., Chang, I. J., Anger, M., Smith, M., Kaplan, M., Zeig, S., Koury, M. J., Blumenthal, S. S., & Lewis, J. B. (2013). Dose-response and efficacy of ferric citrate to treat hyperphosphatemia in hemodialysis patients: a short-term randomized trial. American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation, 61(5), 759-66. https://doi.org/10.1053/j.ajkd.2012.11.041
Dwyer JP, et al. Dose-response and Efficacy of Ferric Citrate to Treat Hyperphosphatemia in Hemodialysis Patients: a Short-term Randomized Trial. Am J Kidney Dis. 2013;61(5):759-66. PubMed PMID: 23369827.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Dose-response and efficacy of ferric citrate to treat hyperphosphatemia in hemodialysis patients: a short-term randomized trial. AU - Dwyer,Jamie P, AU - Sika,Mohammed, AU - Schulman,Gerald, AU - Chang,Ingrid J, AU - Anger,Michael, AU - Smith,Mark, AU - Kaplan,Mark, AU - Zeig,Steven, AU - Koury,Mark J, AU - Blumenthal,Samuel S, AU - Lewis,Julia B, AU - ,, Y1 - 2013/01/29/ PY - 2012/07/24/received PY - 2012/11/07/accepted PY - 2013/2/2/entrez PY - 2013/2/2/pubmed PY - 2013/6/5/medline SP - 759 EP - 66 JF - American journal of kidney diseases : the official journal of the National Kidney Foundation JO - Am J Kidney Dis VL - 61 IS - 5 N2 - BACKGROUND: Most dialysis patients require phosphate binders to control hyperphosphatemia. Ferric citrate has been tested in phase 2 trials as a phosphate binder. This trial was designed as a dose-response and efficacy trial. STUDY DESIGN: Prospective, phase 3, multicenter, open-label, randomized clinical trial. SETTING & PARTICIPANTS: 151 participants with hyperphosphatemia on maintenance hemodialysis therapy. INTERVENTION: Fixed dose of ferric citrate taken orally as a phosphate binder for up to 28 days (1, 6, or 8 g/d in 51, 52, and 48 participants, respectively). OUTCOMES: Primary outcome is dose-response of ferric citrate on serum phosphorus level; secondary outcomes are safety and tolerability. MEASUREMENTS: Serum chemistry tests including phosphorus, safety data. RESULTS: 151 participants received at least one dose of ferric citrate. Mean baseline phosphorus levels were 7.3 ± 1.7 (SD) mg/dL in the 1-g/d group, 7.6 ± 1.7 mg/dL in the 6-g/d group, and 7.5 ± 1.6 mg/dL in the 8-g/d group. Phosphorus levels decreased in a dose-dependent manner (mean change at end of treatment, -0.1 ± 1.3 mg/dL in the 1-g/d group, -1.9 ± 1.7 mg/dL in the 6-g/d group, and -2.1 ± 2.0 mg/dL in the 8-g/d group). The mean difference in reduction in phosphorus levels between the 6- and 1-g/d groups was 1.3 mg/dL (95% CI, 0.69 to 1.9; P < 0.001), between the 8- and 1-g/d groups was 1.5 mg/dL (95% CI, 0.86 to 2.1; P < 0.001), and between the 8- and 6-g/d groups was 0.21 mg/dL (95% CI, -0.39 to 0.81; P = 0.5). The most common adverse event was stool discoloration. LIMITATIONS: Sample size and duration confirm efficacy, but limit our ability to confirm safety. CONCLUSIONS: Ferric citrate is efficacious as a phosphate binder in a dose-dependent manner. A phase 3 trial is ongoing to confirm safety and efficacy. SN - 1523-6838 UR - https://www.unboundmedicine.com/medline/citation/23369827/Dose_response_and_efficacy_of_ferric_citrate_to_treat_hyperphosphatemia_in_hemodialysis_patients:_a_short_term_randomized_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0272-6386(12)01506-5 DB - PRIME DP - Unbound Medicine ER -