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Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease

This study has been completed.
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Kenneth R. Phelps, M.D., Phelps, Kenneth R., M.D. Identifier:
First received: August 27, 2010
Last updated: July 30, 2014
Last verified: July 2014
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.

Condition Intervention Phase
Chronic Kidney Disease
Drug: sevelamer carbonate
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Sevelamer Carbonate on Critical Variables in the Pathogenesis of Secondary Hyperparathyroidism

Resource links provided by NLM:

Further study details as provided by Phelps, Kenneth R., M.D.:

Primary Outcome Measures:
  • Fractional Change in [PTH] in CKD After a 4-week Course of Sevelamer Carbonate [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    This outcome measure documented the effect of intestinal phosphate-binding on [PTH]. Fractional change was calculated as ([PTH]post - [PTH]pre)/[PTH]pre, where 'pre' and 'post' referred respectively to baseline [PTH] (before treatment) and [PTH] after four weeks of treatment. Reductions were cited as negative numbers, and increments were cited as positive numbers.

Secondary Outcome Measures:
  • Linear Regression of [PTH] on Phosphate Excretion Per Volume of Glomerular Filtrate (EP/Ccr) [ Time Frame: at 12 and 16 weeks of trial (pre- and post-treatment) ] [ Designated as safety issue: No ]
    EP/Ccr is proportional to the phosphate concentration in the cortical distal nephron ([P]f). The correlation of [PTH] with EP/Ccr tested the hypothesis that [PTH] varies with the phosphate concentration in filtrate of the cortical distal nephron.

Enrollment: 30
Study Start Date: April 2010
Study Completion Date: April 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: sevelamer carbonate
2400 mg (3 pills) with each meal
Drug: sevelamer carbonate
2400 mg with each meal for 4 weeks
Other Name: sevelamer carbonate = Renvela (Genzyme)
Placebo Comparator: placebo control
3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets.
Drug: placebo
3 tablets with each meal


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • eGFR < 60 ml/min
  • age at least 18 years

Exclusion Criteria:

  • any primary parathyroid disease
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Please refer to this study by its identifier: NCT01191762

United States, New York
Stratton Veterans Affairs Medical Center
Albany, New York, United States, 12208
Sponsors and Collaborators
Kenneth R. Phelps, M.D.
Genzyme, a Sanofi Company
Principal Investigator: Kenneth R. Phelps, M.D. Stratton VAMC, Albany, NY
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kenneth R. Phelps, M.D., Principal Investigator, Phelps, Kenneth R., M.D. Identifier: NCT01191762     History of Changes
Other Study ID Numbers: PhelpsK 
Study First Received: August 27, 2010
Results First Received: November 13, 2013
Last Updated: July 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Phelps, Kenneth R., M.D.:
secondary hyperparathyroidism
chronic kidney disease

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Hyperparathyroidism, Secondary
Urologic Diseases
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action processed this record on October 28, 2016