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Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease

Information source: Phelps, Kenneth R., M.D.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hyperparathyroidism; Chronic Kidney Disease

Intervention: sevelamer carbonate (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Kenneth R. Phelps, M.D.

Official(s) and/or principal investigator(s):
Kenneth R. Phelps, M.D., Principal Investigator, Affiliation: Stratton VAMC, Albany, NY

Summary

The hypothesis underlying this study is that phosphate interferes with PTH-mediated calcium reabsorption in the distal nephron and thereby necessitates supranormal [PTH]to maintain normocalcemia in chronic kidney disease. This study will examine the hypothesis with measures of phosphate homeostasis and calcium reabsorption. A double-blind trial of the intestinal phosphate binder sevelamer carbonate will be employed to examine whether reductions in phosphate influx alter distal nephron phosphate concentration and the [PTH] required for calcium reabsorption in the expected manner.

Clinical Details

Official title: The Effect of Sevelamer Carbonate on Critical Variables in the Pathogenesis of Secondary Hyperparathyroidism

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Fractional Change in [PTH] in CKD After a 4-week Course of Sevelamer Carbonate

Secondary outcome: Linear Regression of [PTH] on Phosphate Excretion Per Volume of Glomerular Filtrate (EP/Ccr)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- eGFR < 60 ml/min

- age at least 18 years

Exclusion Criteria:

- any primary parathyroid disease

Locations and Contacts

Stratton Veterans Affairs Medical Center, Albany, New York 12208, United States
Additional Information

Starting date: April 2010
Last updated: July 30, 2014

Page last updated: August 23, 2015

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