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NCT Number: NCT00687661

Queen's University Investigation of Calcification in Chronic Kidney Disease

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.

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Key information

Conditions

Chronic Kidney Disease Calcinosis Calcium Metabolism Disorders Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Calcification

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

About this study

Presently, there exist few therapies aimed at retarding the progression of vascular calcification. One study showed that agents that limit the absorption of phosphate from food (phosphate binders) slow the progression of vascular calcification, and as a result, treatments emphasize phosphate control through diet and phosphate binders. Other studies have shown that the use of statins, to lower LDL cholesterol levels may reduce the progression of coronary calcification in non-ESRD patients, but data from ESRD are lacking. While these treatments have been helpful, the improvements in patients' outcomes have not been overwhelming positive.

This proposed study is not the first to study the use of bisphosphonates on vascular calcification. Repeated studies have shown impressive reduction in calcification rates in several animal models, which begs the question, how will bisphosphonates fare in human subjects? Preliminary research has begun, but clearly an expansive trial on humans is needed to explore the use of a promising therapy. Our study hopes to provide insight into this area of cardiovascular research.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bisphosphonate

Drug

35mg given orally once weekly for 24 months

Other names: Residronate

Placebo

Drug

identical placebo pill once weekly for 24 months

Primary outcomes

  1. Absolute change in coronary artery calcification score (CaSc) from baseline to study completion.

    Time frame: 24 months

Secondary outcomes

  1. Change in bone density score (wrist/hip) as calculated by Ct scanning method, # fractures, MI, Stroke, amputation/surgery for peripheral revascularization.

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Registry information

Official study title

The Use of Bisphosphonates to Prevent or Delay the Progression of Vascular Calcification in End-Stage Renal Disease: A Randomized Controlled Trial

Acronym: QUICK

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jun 2, 2008
Registry last updated
Sep 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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