Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease
This study is currently recruiting participants.
Verified June 2011 by Phelps, Kenneth R., M.D.
Sponsor:
Phelps, Kenneth R., M.D.
Information provided by:
Phelps, Kenneth R., M.D.
ClinicalTrials.gov Identifier:
NCT01191762
First received: August 27, 2010
Last updated: June 17, 2011
Last verified: June 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 27, 2010 | ||||||||
| Last Updated Date | June 17, 2011 | ||||||||
| Start Date ICMJE | April 2010 | ||||||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Fractional reduction in [PTH] in CKD after a 4-week course of sevelamer carbonate [ Time Frame: 16 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01191762 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Correlation of [PTH] to phosphate excretion per volume of glomerular filtrate [ Time Frame: 16 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease | ||||||||
| Official Title ICMJE | The Effect of Sevelamer Carbonate on Critical Variables in the Pathogenesis of Secondary Hyperparathyroidism | ||||||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Intervention ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||
| Estimated Completion Date | August 2012 | ||||||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01191762 | ||||||||
| Other Study ID Numbers ICMJE | PhelpsK | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Kenneth R. Phelps, M.D. | ||||||||
| Study Sponsor ICMJE | Phelps, Kenneth R., M.D. | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Phelps, Kenneth R., M.D. | ||||||||
| Verification Date | June 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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