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Effect of oral JTT-751 (ferric citrate) on hyperphosphatemia in hemodialysis patients: results of a randomized, double-blind, placebo-controlled trial.
Am J Nephrol. 2012; 36(5):478-87.AJ

Abstract

BACKGROUND/AIMS

JTT-751 (ferric citrate hydrate) is a novel oral, iron-based phosphate binder being developed for the treatment of hyperphosphatemia among chronic kidney disease patients who are on dialysis. This study investigated the dose-response and safety of JTT-751 among Japanese hemodialysis patients.

METHODS

This was a multicenter, randomized, placebo-controlled, double-blind, parallel-group, comparative study. A total of 192 subjects with serum phosphorus (P) levels between 6.1 and 10.0 mg/dl were randomized to JTT-751 (1.5, 3 or 6 g/day) or to placebo treatment for 28 days. Changes in serum P level from baseline were examined.

RESULTS

In the full analysis set, the mean change in serum P level at week 4 was 0.04, -1.28, -2.16 and -4.10 mg/dl in the placebo, 1.5-grams, 3-grams and 6-grams/day groups, respectively, demonstrating a dose-response relationship up to 6 g/day. Overall, a reduction in serum P levels to ≤5.5 mg/dl was achieved in 2.5, 16.7, 50.0 and 92.6% of subjects, in the placebo, 1.5-grams, 3-grams and 6-grams/day groups, respectively. The most common adverse events (AEs) were gastrointestinal disorders. Most AEs were mild. In 25 patients, treatment was discontinued due to increased transferrin saturation ≥50%; however, this was not considered to be a safety issue.

CONCLUSIONS

When hemodialysis subjects received JTT-751 at doses between 1.5 and 6 g/day for 28 days, serum P levels were significantly reduced in a dose-dependent manner (p < 0.001). JTT-751 was found to be efficacious and safe, with the majority of subjects in the 6-grams/day group achieving a serum P level of ≤5.5 mg/dl.

Authors+Show Affiliations

Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan. keitaro@jikei.ac.jpNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

23147696

Citation

Yokoyama, Keitaro, et al. "Effect of Oral JTT-751 (ferric Citrate) On Hyperphosphatemia in Hemodialysis Patients: Results of a Randomized, Double-blind, Placebo-controlled Trial." American Journal of Nephrology, vol. 36, no. 5, 2012, pp. 478-87.
Yokoyama K, Hirakata H, Akiba T, et al. Effect of oral JTT-751 (ferric citrate) on hyperphosphatemia in hemodialysis patients: results of a randomized, double-blind, placebo-controlled trial. Am J Nephrol. 2012;36(5):478-87.
Yokoyama, K., Hirakata, H., Akiba, T., Sawada, K., & Kumagai, Y. (2012). Effect of oral JTT-751 (ferric citrate) on hyperphosphatemia in hemodialysis patients: results of a randomized, double-blind, placebo-controlled trial. American Journal of Nephrology, 36(5), 478-87. https://doi.org/10.1159/000344008
Yokoyama K, et al. Effect of Oral JTT-751 (ferric Citrate) On Hyperphosphatemia in Hemodialysis Patients: Results of a Randomized, Double-blind, Placebo-controlled Trial. Am J Nephrol. 2012;36(5):478-87. PubMed PMID: 23147696.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of oral JTT-751 (ferric citrate) on hyperphosphatemia in hemodialysis patients: results of a randomized, double-blind, placebo-controlled trial. AU - Yokoyama,Keitaro, AU - Hirakata,Hideki, AU - Akiba,Takashi, AU - Sawada,Kenichi, AU - Kumagai,Yuji, Y1 - 2012/11/07/ PY - 2012/07/11/received PY - 2012/10/09/accepted PY - 2012/11/14/entrez PY - 2012/11/14/pubmed PY - 2013/5/15/medline SP - 478 EP - 87 JF - American journal of nephrology JO - Am J Nephrol VL - 36 IS - 5 N2 - BACKGROUND/AIMS: JTT-751 (ferric citrate hydrate) is a novel oral, iron-based phosphate binder being developed for the treatment of hyperphosphatemia among chronic kidney disease patients who are on dialysis. This study investigated the dose-response and safety of JTT-751 among Japanese hemodialysis patients. METHODS: This was a multicenter, randomized, placebo-controlled, double-blind, parallel-group, comparative study. A total of 192 subjects with serum phosphorus (P) levels between 6.1 and 10.0 mg/dl were randomized to JTT-751 (1.5, 3 or 6 g/day) or to placebo treatment for 28 days. Changes in serum P level from baseline were examined. RESULTS: In the full analysis set, the mean change in serum P level at week 4 was 0.04, -1.28, -2.16 and -4.10 mg/dl in the placebo, 1.5-grams, 3-grams and 6-grams/day groups, respectively, demonstrating a dose-response relationship up to 6 g/day. Overall, a reduction in serum P levels to ≤5.5 mg/dl was achieved in 2.5, 16.7, 50.0 and 92.6% of subjects, in the placebo, 1.5-grams, 3-grams and 6-grams/day groups, respectively. The most common adverse events (AEs) were gastrointestinal disorders. Most AEs were mild. In 25 patients, treatment was discontinued due to increased transferrin saturation ≥50%; however, this was not considered to be a safety issue. CONCLUSIONS: When hemodialysis subjects received JTT-751 at doses between 1.5 and 6 g/day for 28 days, serum P levels were significantly reduced in a dose-dependent manner (p < 0.001). JTT-751 was found to be efficacious and safe, with the majority of subjects in the 6-grams/day group achieving a serum P level of ≤5.5 mg/dl. SN - 1421-9670 UR - https://www.unboundmedicine.com/medline/citation/23147696/Effect_of_oral_JTT_751__ferric_citrate__on_hyperphosphatemia_in_hemodialysis_patients:_results_of_a_randomized_double_blind_placebo_controlled_trial_ L2 - https://www.karger.com?DOI=10.1159/000344008 DB - PRIME DP - Unbound Medicine ER -