Phosphate Lowering in CKD Trial

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. \[COMIRB 15-0384\]

Conditions

• Chronic Kidney Disease
• Cardiovascular Disease

Interventions

DRUG

Lanthanum carbonate

Non-calcium containing phosphorus binder

DRUG

placebo

Table identical to lanthanum carbonate but with no active ingredient

DRUG

Ascorbic Acid

Intravenous administration during measurement of flow mediated dilation.

DRUG

Nitroglycerin

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

PROCEDURE

Flow-mediated dilation measurement

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

PROCEDURE

Aortic pulse-wave velocity

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.

PROCEDURE

Endothelial cell collection

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.

Sponsors & Collaborators

• VA Office of Research and Development

  lead FED

Principal Investigators

• Anna J Jovanovich, MD · Rocky Mountain Regional VA Medical Center, Aurora, CO

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-09-15

Primary Completion

2019-06-28

Completion

2019-12-20

FDA Drug

Yes

Countries

• United States

Study Locations