CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 66 enrolled
Drug / intervention
Lanthanum carbonate +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02209636
NCT02209636Phase 4Completed

Phosphate Lowering to Treat Vascular Dysfunction in Chronic Kidney Disease

VA Office of Research and Development·interventional·Posted Aug 6, 2014·Updated Aug 26, 2022

In Brief

A Phase 4 clinical trial evaluating Lanthanum carbonate, placebo, and 5 other interventions for Chronic Kidney Disease and Cardiovascular Disease. Completed, enrolled 66 participants across 1 site.

Detailed 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. \[COMIRB 15-0384\]

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 6, 2014
Enrollment StartSep 15, 2014
Primary CompletionJun 28, 2019
Study CompletionDec 20, 2019
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 11.9 years ago

Interventions

Lanthanum carbonatedrug

Non-calcium containing phosphorus binder

placebodrug

Table identical to lanthanum carbonate but with no active ingredient

Ascorbic Aciddrug

Intravenous administration during measurement of flow mediated dilation.

Nitroglycerindrug

Drug that is administered under the tongue that relaxes blood vessels. To be administered during measurement of flow mediated dilation.

Flow-mediated dilation measurementprocedure

Measurement of the blood flow in the brachial artery, an artery in the upper arm, using ultrasound.

Aortic pulse-wave velocityprocedure

Measurement of the stiffness of the arteries using a transcutaneous tonometer, a small device placed over the skin over the carotid, brachial, radial and femoral arteries.

Endothelial cell collectionprocedure

Collection of endothelial cells from vein in arm. A flexible wire is inserted through an IV into a forearm vein to collect endothelial cells for further study. This is performed at the baseline visit and and the final study visit.