Tags

Type your tag names separated by a space and hit enter

A randomized trial of sevelamer hydrochloride (RenaGel) with and without supplemental calcium. Strategies for the control of hyperphosphatemia and hyperparathyroidism in hemodialysis patients.
Clin Nephrol. 1999 Jan; 51(1):18-26.CN

Abstract

OBJECTIVE

We have previously shown sevelamer hydrochloride (RenaGel) to be an effective and well-tolerated treatment for hyperphosphatemia in hemodialysis patients.

PATIENTS AND METHODS

We performed a randomized clinical trial to compare the efficacy of RenaGel alone and RenaGel with calcium, using the serum phosphorus concentration and intact parathyroid hormone (PTH) as the principal outcomes of interest. Calcium (900 mg elemental) was provided as a once-nightly dose on an empty stomach. 71 patients were randomized and included in the intent-to-treat population; 55 completed the 16-week study period (2 weeks washout, 12 weeks treatment, 2 weeks washout). 49% of subjects were taking vitamin D metabolites.

RESULTS

Serum phosphorus and PTH rose significantly when patients stopped their phosphate binders during both washout periods. RenaGel and RenaGel with calcium were equally effective at reducing serum phosphorus (mean change -2.4 mg/dL vs. -2.3 mg/dL). RenaGel with calcium was associated with a small increase in serum calcium (mean change 0.3 mg/dL vs. 0.0 mg/dL in RenaGel group, P = 0.09) that was not statistically significant. During the treatment phase, the reduction in PTH tended to be greater in the RenaGel with calcium group (median change -67.0 vs. -22.5 pg/mL in RenaGel group, P = 0.07). Non-users of vitamin D metabolites treated with RenaGel with calcium experienced a significant decrease in PTH (median change -114.5 vs. -22 pg/mL in RenaGel group, P = 0.006). Adverse events were seen with equal frequency in both groups, being generally mild in intensity, and rarely attributable to the drugs.

CONCLUSION

We conclude that RenaGel and RenaGel with calcium are similarly effective in the treatment of ESRD-related hyperphosphatemia. Provision of supplemental calcium or metabolites of vitamin D with RenaGel may enhance control of hyperparathyroidism.

Authors+Show Affiliations

Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, 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 available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

9988142

Citation

Chertow, G M., et al. "A Randomized Trial of Sevelamer Hydrochloride (RenaGel) With and Without Supplemental Calcium. Strategies for the Control of Hyperphosphatemia and Hyperparathyroidism in Hemodialysis Patients." Clinical Nephrology, vol. 51, no. 1, 1999, pp. 18-26.
Chertow GM, Dillon M, Burke SK, et al. A randomized trial of sevelamer hydrochloride (RenaGel) with and without supplemental calcium. Strategies for the control of hyperphosphatemia and hyperparathyroidism in hemodialysis patients. Clin Nephrol. 1999;51(1):18-26.
Chertow, G. M., Dillon, M., Burke, S. K., Steg, M., Bleyer, A. J., Garrett, B. N., Domoto, D. T., Wilkes, B. M., Wombolt, D. G., & Slatopolsky, E. (1999). A randomized trial of sevelamer hydrochloride (RenaGel) with and without supplemental calcium. Strategies for the control of hyperphosphatemia and hyperparathyroidism in hemodialysis patients. Clinical Nephrology, 51(1), 18-26.
Chertow GM, et al. A Randomized Trial of Sevelamer Hydrochloride (RenaGel) With and Without Supplemental Calcium. Strategies for the Control of Hyperphosphatemia and Hyperparathyroidism in Hemodialysis Patients. Clin Nephrol. 1999;51(1):18-26. PubMed PMID: 9988142.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized trial of sevelamer hydrochloride (RenaGel) with and without supplemental calcium. Strategies for the control of hyperphosphatemia and hyperparathyroidism in hemodialysis patients. AU - Chertow,G M, AU - Dillon,M, AU - Burke,S K, AU - Steg,M, AU - Bleyer,A J, AU - Garrett,B N, AU - Domoto,D T, AU - Wilkes,B M, AU - Wombolt,D G, AU - Slatopolsky,E, PY - 1999/2/13/pubmed PY - 1999/2/13/medline PY - 1999/2/13/entrez SP - 18 EP - 26 JF - Clinical nephrology JO - Clin Nephrol VL - 51 IS - 1 N2 - OBJECTIVE: We have previously shown sevelamer hydrochloride (RenaGel) to be an effective and well-tolerated treatment for hyperphosphatemia in hemodialysis patients. PATIENTS AND METHODS: We performed a randomized clinical trial to compare the efficacy of RenaGel alone and RenaGel with calcium, using the serum phosphorus concentration and intact parathyroid hormone (PTH) as the principal outcomes of interest. Calcium (900 mg elemental) was provided as a once-nightly dose on an empty stomach. 71 patients were randomized and included in the intent-to-treat population; 55 completed the 16-week study period (2 weeks washout, 12 weeks treatment, 2 weeks washout). 49% of subjects were taking vitamin D metabolites. RESULTS: Serum phosphorus and PTH rose significantly when patients stopped their phosphate binders during both washout periods. RenaGel and RenaGel with calcium were equally effective at reducing serum phosphorus (mean change -2.4 mg/dL vs. -2.3 mg/dL). RenaGel with calcium was associated with a small increase in serum calcium (mean change 0.3 mg/dL vs. 0.0 mg/dL in RenaGel group, P = 0.09) that was not statistically significant. During the treatment phase, the reduction in PTH tended to be greater in the RenaGel with calcium group (median change -67.0 vs. -22.5 pg/mL in RenaGel group, P = 0.07). Non-users of vitamin D metabolites treated with RenaGel with calcium experienced a significant decrease in PTH (median change -114.5 vs. -22 pg/mL in RenaGel group, P = 0.006). Adverse events were seen with equal frequency in both groups, being generally mild in intensity, and rarely attributable to the drugs. CONCLUSION: We conclude that RenaGel and RenaGel with calcium are similarly effective in the treatment of ESRD-related hyperphosphatemia. Provision of supplemental calcium or metabolites of vitamin D with RenaGel may enhance control of hyperparathyroidism. SN - 0301-0430 UR - https://www.unboundmedicine.com/medline/citation/9988142/A_randomized_trial_of_sevelamer_hydrochloride__RenaGel__with_and_without_supplemental_calcium__Strategies_for_the_control_of_hyperphosphatemia_and_hyperparathyroidism_in_hemodialysis_patients_ L2 - https://medlineplus.gov/kidneyfailure.html DB - PRIME DP - Unbound Medicine ER -