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A randomized trial of JTT-751 versus sevelamer hydrochloride in patients on hemodialysis.
Nephrol Dial Transplant. 2014 May; 29(5):1053-60.ND

Abstract

BACKGROUND

JTT-751 is a novel phosphate binder containing ferric citrate as the active ingredient.

METHODS

In this Phase 3, multicenter, randomized, open-label, parallel-group study, we compared the efficacy and safety of JTT-751 and sevelamer hydrochloride in patients undergoing hemodialysis. A total of 230 patients with a serum phosphate ≥1.97 and <3.23 mmol/L were randomized to JTT-751 (dose adjusted between 1.5 and 6.0 g/day) or sevelamer hydrochloride (dose adjusted between 3.0 and 9.0 g/day) for 12 weeks. The primary outcome was change in serum phosphate from baseline to end of treatment. Secondary outcomes included the changes in corrected serum calcium and intact parathyroid hormone (PTH). The changes in ferritin, transferrin saturation and erythropoiesis-stimulating agent dose were additional outcomes.

RESULTS

Changes in serum phosphate at the end of treatment were -0.82 mmol/L in the JTT-751 group and -0.78 mmol/L in the sevelamer group, establishing non-inferiority of JTT-751 compared with sevelamer (least squares mean, -0.03 mmol/L; 95% confidence interval, -0.13 to 0.07 mmol/L). Corrected serum calcium increased and PTH decreased from baseline within both groups; changes between groups were similar. Gastrointestinal disorders were the most common adverse events in both groups; the incidence of diarrhea was higher in the JTT-751 group, while constipation occurred frequently in the sevelamer group. Treatment with JTT-751 resulted in significant relative increases in serum ferritin and transferrin saturation.

CONCLUSIONS

Efficacy and safety of JTT-751 was comparable to sevelamer in patients on hemodialysis with hyperphosphatemia. Differential adverse effects were observed; biochemical markers of iron status increased in patients treated with JTT-751.

TRIAL REGISTRATION NUMBER

CTI-111433 (The Japan Pharmaceutical Information Center at: http//www.clinicaltrials.jp). Date of registration: 7 March 2011.

Authors+Show Affiliations

Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.No 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

24376274

Citation

Yokoyama, Keitaro, et al. "A Randomized Trial of JTT-751 Versus Sevelamer Hydrochloride in Patients On Hemodialysis." Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association, vol. 29, no. 5, 2014, pp. 1053-60.
Yokoyama K, Akiba T, Fukagawa M, et al. A randomized trial of JTT-751 versus sevelamer hydrochloride in patients on hemodialysis. Nephrol Dial Transplant. 2014;29(5):1053-60.
Yokoyama, K., Akiba, T., Fukagawa, M., Nakayama, M., Sawada, K., Kumagai, Y., Chertow, G. M., & Hirakata, H. (2014). A randomized trial of JTT-751 versus sevelamer hydrochloride in patients on hemodialysis. Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association, 29(5), 1053-60. https://doi.org/10.1093/ndt/gft483
Yokoyama K, et al. A Randomized Trial of JTT-751 Versus Sevelamer Hydrochloride in Patients On Hemodialysis. Nephrol Dial Transplant. 2014;29(5):1053-60. PubMed PMID: 24376274.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized trial of JTT-751 versus sevelamer hydrochloride in patients on hemodialysis. AU - Yokoyama,Keitaro, AU - Akiba,Takashi, AU - Fukagawa,Masafumi, AU - Nakayama,Masaaki, AU - Sawada,Kenichi, AU - Kumagai,Yuji, AU - Chertow,Glenn M, AU - Hirakata,Hideki, Y1 - 2013/12/26/ PY - 2013/12/31/entrez PY - 2014/1/1/pubmed PY - 2014/9/27/medline KW - clinical trial KW - ferric citrate KW - hemodialysis KW - hyperphosphatemia KW - phosphate binder SP - 1053 EP - 60 JF - Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association JO - Nephrol Dial Transplant VL - 29 IS - 5 N2 - BACKGROUND: JTT-751 is a novel phosphate binder containing ferric citrate as the active ingredient. METHODS: In this Phase 3, multicenter, randomized, open-label, parallel-group study, we compared the efficacy and safety of JTT-751 and sevelamer hydrochloride in patients undergoing hemodialysis. A total of 230 patients with a serum phosphate ≥1.97 and <3.23 mmol/L were randomized to JTT-751 (dose adjusted between 1.5 and 6.0 g/day) or sevelamer hydrochloride (dose adjusted between 3.0 and 9.0 g/day) for 12 weeks. The primary outcome was change in serum phosphate from baseline to end of treatment. Secondary outcomes included the changes in corrected serum calcium and intact parathyroid hormone (PTH). The changes in ferritin, transferrin saturation and erythropoiesis-stimulating agent dose were additional outcomes. RESULTS: Changes in serum phosphate at the end of treatment were -0.82 mmol/L in the JTT-751 group and -0.78 mmol/L in the sevelamer group, establishing non-inferiority of JTT-751 compared with sevelamer (least squares mean, -0.03 mmol/L; 95% confidence interval, -0.13 to 0.07 mmol/L). Corrected serum calcium increased and PTH decreased from baseline within both groups; changes between groups were similar. Gastrointestinal disorders were the most common adverse events in both groups; the incidence of diarrhea was higher in the JTT-751 group, while constipation occurred frequently in the sevelamer group. Treatment with JTT-751 resulted in significant relative increases in serum ferritin and transferrin saturation. CONCLUSIONS: Efficacy and safety of JTT-751 was comparable to sevelamer in patients on hemodialysis with hyperphosphatemia. Differential adverse effects were observed; biochemical markers of iron status increased in patients treated with JTT-751. TRIAL REGISTRATION NUMBER: CTI-111433 (The Japan Pharmaceutical Information Center at: http//www.clinicaltrials.jp). Date of registration: 7 March 2011. SN - 1460-2385 UR - https://www.unboundmedicine.com/medline/citation/24376274/A_randomized_trial_of_JTT_751_versus_sevelamer_hydrochloride_in_patients_on_hemodialysis_ L2 - https://academic.oup.com/ndt/article-lookup/doi/10.1093/ndt/gft483 DB - PRIME DP - Unbound Medicine ER -