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
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