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Prospective randomized multicenter trial of sevelamer hydrochloride and calcium carbonate for the treatment of hyperphosphatemia in hemodialysis patients in Japan.
Ther Apher Dial. 2005 Aug; 9(4):340-6.TA

Abstract

A prospective, randomized open-label trial of sevelamer hydrochloride with or without calcium carbonate (CC) involved 86 hemodialysis patients in Japan. The dosage of CC was fixed at 3.0 g/day for the 12-week study. After the first 4 weeks all subjects were changed from CC to sevelamer 3.0 g/day for another 4 weeks, then allocated randomly to three groups for the final 4 weeks: group A, sevelamer 6.0 g/day; group B, sevelamer 3.0 g/day and CC 3.0 g/day; group C, CC 3.0 g/day. The target serum phosphorous concentration (P)=5.5 mg/dL and the corrected calcium concentration (Ca) was 9.0-10.0 mg/dL. Of the 86 patients, 62 finished the study without a change of dosage and their data were analyzed (group A, N=16; group B, N=26; group C, N=20). At week 8 compared with week 4, the concentration of P increased from 5.7+/-1.4 to 6.4+/-1.7 mg/dL in group A, and decreased significantly in groups B and C, and in group B compared with groups A and C; groups A and C had similar concentrations at week 8. The Ca concentration decreased significantly from 9.7+/-1.0 to 9.1+/-0.7 mg/dL after the change to sevelamer. At week 8 Ca was not significantly changed in group A, whereas a significant increase occurred in groups B and C. Side-effects with sevelamer administration occurred in 34 of the 86 patients and 24 dropped out of the study, with a high frequency in group A (13/29; 44.8%). In conclusion, there was an additive effect of sevelamer for the treatment of hyperphosphatemia with CC. The combination therapy was better tolerated and showed higher patient compliance than CC or sevelamer monotherapy.

Authors+Show Affiliations

Division of Nephrology, Showa University Fujigaoka Hospital, Yokohama, 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)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

16076379

Citation

Koiwa, Fumihiko, et al. "Prospective Randomized Multicenter Trial of Sevelamer Hydrochloride and Calcium Carbonate for the Treatment of Hyperphosphatemia in Hemodialysis Patients in Japan." Therapeutic Apheresis and Dialysis : Official Peer-reviewed Journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy, vol. 9, no. 4, 2005, pp. 340-6.
Koiwa F, Onoda N, Kato H, et al. Prospective randomized multicenter trial of sevelamer hydrochloride and calcium carbonate for the treatment of hyperphosphatemia in hemodialysis patients in Japan. Ther Apher Dial. 2005;9(4):340-6.
Koiwa, F., Onoda, N., Kato, H., Tokumoto, A., Okada, T., Fukagawa, M., & Shigematsu, T. (2005). Prospective randomized multicenter trial of sevelamer hydrochloride and calcium carbonate for the treatment of hyperphosphatemia in hemodialysis patients in Japan. Therapeutic Apheresis and Dialysis : Official Peer-reviewed Journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy, 9(4), 340-6.
Koiwa F, et al. Prospective Randomized Multicenter Trial of Sevelamer Hydrochloride and Calcium Carbonate for the Treatment of Hyperphosphatemia in Hemodialysis Patients in Japan. Ther Apher Dial. 2005;9(4):340-6. PubMed PMID: 16076379.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Prospective randomized multicenter trial of sevelamer hydrochloride and calcium carbonate for the treatment of hyperphosphatemia in hemodialysis patients in Japan. AU - Koiwa,Fumihiko, AU - Onoda,Noritaka, AU - Kato,Hitoshi, AU - Tokumoto,Akihide, AU - Okada,Tomoyuki, AU - Fukagawa,Masashi, AU - Shigematsu,Takashi, AU - ,, PY - 2005/8/4/pubmed PY - 2005/12/15/medline PY - 2005/8/4/entrez SP - 340 EP - 6 JF - Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy JO - Ther Apher Dial VL - 9 IS - 4 N2 - A prospective, randomized open-label trial of sevelamer hydrochloride with or without calcium carbonate (CC) involved 86 hemodialysis patients in Japan. The dosage of CC was fixed at 3.0 g/day for the 12-week study. After the first 4 weeks all subjects were changed from CC to sevelamer 3.0 g/day for another 4 weeks, then allocated randomly to three groups for the final 4 weeks: group A, sevelamer 6.0 g/day; group B, sevelamer 3.0 g/day and CC 3.0 g/day; group C, CC 3.0 g/day. The target serum phosphorous concentration (P)=5.5 mg/dL and the corrected calcium concentration (Ca) was 9.0-10.0 mg/dL. Of the 86 patients, 62 finished the study without a change of dosage and their data were analyzed (group A, N=16; group B, N=26; group C, N=20). At week 8 compared with week 4, the concentration of P increased from 5.7+/-1.4 to 6.4+/-1.7 mg/dL in group A, and decreased significantly in groups B and C, and in group B compared with groups A and C; groups A and C had similar concentrations at week 8. The Ca concentration decreased significantly from 9.7+/-1.0 to 9.1+/-0.7 mg/dL after the change to sevelamer. At week 8 Ca was not significantly changed in group A, whereas a significant increase occurred in groups B and C. Side-effects with sevelamer administration occurred in 34 of the 86 patients and 24 dropped out of the study, with a high frequency in group A (13/29; 44.8%). In conclusion, there was an additive effect of sevelamer for the treatment of hyperphosphatemia with CC. The combination therapy was better tolerated and showed higher patient compliance than CC or sevelamer monotherapy. SN - 1744-9979 UR - https://www.unboundmedicine.com/medline/citation/16076379/Prospective_randomized_multicenter_trial_of_sevelamer_hydrochloride_and_calcium_carbonate_for_the_treatment_of_hyperphosphatemia_in_hemodialysis_patients_in_Japan_ L2 - https://doi.org/10.1111/j.1744-9987.2005.00294.x DB - PRIME DP - Unbound Medicine ER -