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Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease

This study has been completed.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Kenneth R. Phelps, M.D., Phelps, Kenneth R., M.D.
ClinicalTrials.gov Identifier:
NCT01191762
First received: August 27, 2010
Last updated: July 30, 2014
Last verified: July 2014

August 27, 2010
July 30, 2014
April 2010
August 2012   (final data collection date for primary outcome measure)
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.
Fractional reduction in [PTH] in CKD after a 4-week course of sevelamer carbonate [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01191762 on ClinicalTrials.gov Archive Site
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.
Correlation of [PTH] to phosphate excretion per volume of glomerular filtrate [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease
The Effect of Sevelamer Carbonate on Critical Variables in the Pathogenesis of Secondary Hyperparathyroidism

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Hyperparathyroidism
  • Chronic Kidney Disease
  • Drug: sevelamer carbonate
    2400 mg with each meal for 4 weeks
    Other Name: sevelamer carbonate = Renvela (Genzyme)
  • Drug: placebo
    3 tablets with each meal
  • Active Comparator: sevelamer carbonate
    2400 mg (3 pills) with each meal
    Intervention: Drug: sevelamer carbonate
  • Placebo Comparator: placebo control
    3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets.
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
April 2013
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • any primary parathyroid disease
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01191762
PhelpsK
No
Kenneth R. Phelps, M.D., Phelps, Kenneth R., M.D.
Kenneth R. Phelps, M.D.
Genzyme, a Sanofi Company
Principal Investigator: Kenneth R. Phelps, M.D. Stratton VAMC, Albany, NY
Phelps, Kenneth R., M.D.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP