Queen's University Investigation of Calcification in Chronic Kidney Disease

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Kidney disease is a fundamental part of medicine because of its prominence in Western society. Common conditions such as diabetes, hypertension and kidney infections can all progress to End-Stage Renal Disease (ESRD) also known as Stage 5 chronic kidney disease (CKD 5). Once ESRD has begun, kidney function is poor at best, thus the body is unable to effectively clear harmful toxins from the blood.

A common feature of ESRD is vascular calcification, a process where blood vessels (especially arteries) attract deposits of the mineral calcium. Over time, these deposits harden and thicken in the layers of blood vessels, which limit blood flow to body tissues and can produce significant disease including hypertension, heart disease and stroke. Although the process of vascular calcification is unknown, there is mounting evidence that it is mediated by cellular events that are similar to those seen in bone formation with in the body (osteogenesis). With this point in mind, it has been suggested that agents medicine employs to limit excess bone formation will reduce the rate of vascular calcification in CKD Stage 5.

This study will employ one group of drugs called bisphosphonates which have been used to limit bone formation. It will study their effect on vascular calcification in adult dialysis patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Queen's University
• Treatments: Diphosphonates

Criteria

Inclusion Criteria:

• 18 years of age

• receiving maintenance renal replacement therapy for less than 12 months

• incident patients starting renal replacement therapy for the first time

Exclusion Criteria:

• active vasculitis

• severe hypocalcemia

• previous adverse side effect to bisphosphonate use

• current use of corticosteroids

• weight greater than 300 pounds

• pregnancy

• not expected to survive greater than one year

• expected to discontinue renal replacement therapy during the study period or recover renal function

• evidence of adynamic bone disease

• current bisphosphonate use