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NCT01191762 · ClinicalTrials.gov registry record · Phase 3
Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease
A Phase 3 study of Chronic Kidney Disease and Hyperparathyroidism, sponsored by Kenneth R. Phelps, M.D..
- Completed
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT01191762: Completed Phase 3 study of Chronic Kidney Disease and Hyperparathyroidism, sponsored by Kenneth R. Phelps, M.D..
NCT01191762 is a Phase 3 study of Chronic Kidney Disease and Hyperparathyroidism that has completed, run by Kenneth R. Phelps, M.D.. The registered enrollment target is 30 participants, below the 3,207-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01191762, a Phase 3 study of Chronic Kidney Disease and Hyperparathyroidism, has completed, sponsored by Kenneth R. Phelps, M.D..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG placebo
- DRUG sevelamer carbonate
Study Locations (1)
New York
- Stratton Veterans Affairs Medical Center - Albany
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2010-04 |
| Est. Completion | 2013-04 |
| Phase | Phase 3 |
What the finished NCT01191762 record still lists
NCT01191762 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 3,207-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Chronic Kidney Disease appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT01191762 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01191762 about?
NCT01191762 is a clinical study titled "Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease". 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 homeostasi...
What is the current status of trial NCT01191762?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2010-04. Estimated completion is 2013-04.
What conditions does trial NCT01191762 study?
This clinical trial studies the following conditions: Chronic Kidney Disease, Hyperparathyroidism.
What interventions are being tested in trial NCT01191762?
The interventions under investigation include: placebo (DRUG), sevelamer carbonate (DRUG).
Who is sponsoring clinical trial NCT01191762?
This trial is sponsored by Kenneth R. Phelps, M.D., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01191762 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01191762's enrollment target sits among peer trials
30 84th of 101 higher than 17 of 101 other Chronic Kidney Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Kidney Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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