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Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease

NCT01191762 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-11-01

Study results available
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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.

Conditions

Interventions

DRUG

sevelamer carbonate

2400 mg with each meal for 4 weeks

DRUG

placebo

3 tablets with each meal

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • Kenneth R. Phelps, M.D.

    lead INDIV

Principal Investigators

  • Kenneth R. Phelps, M.D. · Stratton VAMC, Albany, NY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-08-31
Completion
2013-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01191762 on ClinicalTrials.gov