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JTT-751 for treatment of patients with hyperphosphatemia on peritoneal dialysis.
Nephron Clin Pract. 2014; 128(1-2):135-40.NC

Abstract

BACKGROUND/AIMS

JTT-751 (ferric citrate hydrate) is a novel iron-based phosphate approved in Japan for the treatment of hyperphosphatemia in dialysis and nondialysis patients with chronic kidney disease.

METHODS

In this phase 3, multicenter, open-label, dose-adjusted study, we investigated the efficacy and safety of JTT-751 in peritoneal dialysis patients. A total of 56 patients with serum phosphate ≥5.6 and <10.0 mg/dl were enrolled in the study. The dose of JTT-751 was adjusted to between 1.5 and 6.0 g/day, according to the target range of serum phosphate (3.5-5.5 mg/dl), for 12 weeks. The primary endpoint was change in serum phosphate from baseline to end of treatment. Secondary endpoints included the percentage of patients achieving target serum phosphate levels and changes in intact parathyroid hormone.

RESULTS

Serum phosphate was significantly reduced by 2.26 mg/dl (p < 0.001). The percentage of patients achieving target serum phosphate levels was 76.8%. Intact parathyroid hormone decreased significantly (p < 0.001). The most common adverse drug reactions were diarrhea and constipation. Most of the events were considered to be mild. Treatment with JTT-751 resulted in significant increases in serum ferritin and transferrin saturation (p < 0.001).

CONCLUSION

In peritoneal dialysis patients with hyperphosphatemia, 12-week treatment with JTT-751 resulted in significant reductions in serum phosphate while simultaneously increasing serum iron parameters. JTT-751 was well tolerated.

Authors+Show Affiliations

Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

25401266

Citation

Yokoyama, Keitaro, et al. "JTT-751 for Treatment of Patients With Hyperphosphatemia On Peritoneal Dialysis." Nephron. Clinical Practice, vol. 128, no. 1-2, 2014, pp. 135-40.
Yokoyama K, Akiba T, Fukagawa M, et al. JTT-751 for treatment of patients with hyperphosphatemia on peritoneal dialysis. Nephron Clin Pract. 2014;128(1-2):135-40.
Yokoyama, K., Akiba, T., Fukagawa, M., Nakayama, M., & Hirakata, H. (2014). JTT-751 for treatment of patients with hyperphosphatemia on peritoneal dialysis. Nephron. Clinical Practice, 128(1-2), 135-40. https://doi.org/10.1159/000366482
Yokoyama K, et al. JTT-751 for Treatment of Patients With Hyperphosphatemia On Peritoneal Dialysis. Nephron Clin Pract. 2014;128(1-2):135-40. PubMed PMID: 25401266.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - JTT-751 for treatment of patients with hyperphosphatemia on peritoneal dialysis. AU - Yokoyama,Keitaro, AU - Akiba,Takashi, AU - Fukagawa,Masafumi, AU - Nakayama,Masaaki, AU - Hirakata,Hideki, Y1 - 2014/11/11/ PY - 2014/05/07/received PY - 2014/08/04/accepted PY - 2014/11/18/entrez PY - 2014/11/18/pubmed PY - 2015/7/24/medline SP - 135 EP - 40 JF - Nephron. Clinical practice JO - Nephron Clin Pract VL - 128 IS - 1-2 N2 - BACKGROUND/AIMS: JTT-751 (ferric citrate hydrate) is a novel iron-based phosphate approved in Japan for the treatment of hyperphosphatemia in dialysis and nondialysis patients with chronic kidney disease. METHODS: In this phase 3, multicenter, open-label, dose-adjusted study, we investigated the efficacy and safety of JTT-751 in peritoneal dialysis patients. A total of 56 patients with serum phosphate ≥5.6 and <10.0 mg/dl were enrolled in the study. The dose of JTT-751 was adjusted to between 1.5 and 6.0 g/day, according to the target range of serum phosphate (3.5-5.5 mg/dl), for 12 weeks. The primary endpoint was change in serum phosphate from baseline to end of treatment. Secondary endpoints included the percentage of patients achieving target serum phosphate levels and changes in intact parathyroid hormone. RESULTS: Serum phosphate was significantly reduced by 2.26 mg/dl (p < 0.001). The percentage of patients achieving target serum phosphate levels was 76.8%. Intact parathyroid hormone decreased significantly (p < 0.001). The most common adverse drug reactions were diarrhea and constipation. Most of the events were considered to be mild. Treatment with JTT-751 resulted in significant increases in serum ferritin and transferrin saturation (p < 0.001). CONCLUSION: In peritoneal dialysis patients with hyperphosphatemia, 12-week treatment with JTT-751 resulted in significant reductions in serum phosphate while simultaneously increasing serum iron parameters. JTT-751 was well tolerated. SN - 1660-2110 UR - https://www.unboundmedicine.com/medline/citation/25401266/JTT_751_for_treatment_of_patients_with_hyperphosphatemia_on_peritoneal_dialysis_ L2 - https://www.karger.com?DOI=10.1159/000366482 DB - PRIME DP - Unbound Medicine ER -