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NCT02209636 · ClinicalTrials.gov registry record · Phase 4
Phosphate Lowering in CKD Trial
A Phase 4 study of Cardiovascular Disease and Chronic Kidney Disease, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 4
- Development phase
- 66
- Enrollment target
- 1
- Study location
NCT02209636: Completed Phase 4 study of Cardiovascular Disease and Chronic Kidney Disease, sponsored by VA Office of Research and Development.
NCT02209636 is a Phase 4 study of Cardiovascular Disease and Chronic Kidney Disease that has completed, run by VA Office of Research and Development. The registered enrollment target is 66 participants, below the 2,697-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02209636, a Phase 4 study of Cardiovascular Disease and Chronic Kidney Disease, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 66 participants
- Enrollment target
- 1
- Study location
Study Summary
The proposed research is a randomized-controlled trial to determine the effectiveness of reducing serum phosphorus using a phosphate binder, lanthanum carbonate, for improving the function of arteries in adults with moderate to severe chronic kidney disease (CKD). \[COMIRB 13-0328\] Additionally, it will determine phosphorus balance among adults with CKD and whether there is a difference in phosphorus balance after three months of treatment with lanthanum carbonate. \[COMIRB 15-0384\]
Primary Outcome
Measurement of how well the brachial artery dilates in response to shear stress. It is a measure of endothelial function. It is reported as "percent change", which represents the change in dilation of the artery before and after occlusion. Brachial artery flow-mediated dilation will be measured at baseline and at 12 weeks (end-of-study) in the treatment and placebo groups to determine if there is a change brachial artery flow mediated dilation from baseline to 12 weeks and if this change is sig
Conditions Studied
Interventions
- DRUG placebo
- DRUG Ascorbic Acid
- DRUG Nitroglycerin
- DRUG Lanthanum carbonate
- PROCEDURE Flow-mediated dilation measurement
Study Locations (1)
Colorado
- Rocky Mountain Regional VA Medical Center, Aurora, CO - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2014-09-15 |
| Est. Completion | 2019-12-20 |
| Phase | Phase 4 |
What the finished NCT02209636 record still lists
NCT02209636 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 2,697-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Cardiovascular Disease appearing as the primary indexed condition, and to 5 interventions - of which placebo is the first listed.
NCT02209636 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT02209636 about?
NCT02209636 is a clinical study titled "Phosphate Lowering in CKD Trial". The proposed research is a randomized-controlled trial to determine the effectiveness of reducing serum phosphorus using a phosphate binder, lanthanum carbonate, for improving the function of arteries in adults with moderate to severe chronic kidney disease (CKD). \[COMIRB 13-0328\] Additionally, it...
What is the current status of trial NCT02209636?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 66 participants. The study started on 2014-09-15. Estimated completion is 2019-12-20.
What conditions does trial NCT02209636 study?
This clinical trial studies the following conditions: Cardiovascular Disease, Chronic Kidney Disease.
What interventions are being tested in trial NCT02209636?
The interventions under investigation include: placebo (DRUG), Ascorbic Acid (DRUG), Nitroglycerin (DRUG), Lanthanum carbonate (DRUG), Flow-mediated dilation measurement (PROCEDURE).
Who is sponsoring clinical trial NCT02209636?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02209636 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02209636's enrollment target sits among peer trials
66 94th of 137 higher than 44 of 137 other Cardiovascular Disease trials
participants (enrollment target), bucketed by value
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