Queen's University Investigation of Calcification in Chronic Kidney Disease (QUICK)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Karen Yeates, Queen's University
ClinicalTrials.gov Identifier:
NCT00687661
First received: May 28, 2008
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
Drug: Bisphosphonate
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: The Use of Bisphosphonates to Prevent or Delay the Progression of Vascular Calcification in End-Stage Renal Disease: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Absolute change in coronary artery calcification score (CaSc) from baseline to study completion. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Arm #1 will include patients randomized to receive bisphosphonate therapy for 24 months.
Drug: Bisphosphonate
35mg given orally once weekly for 24 months
Other Name: Residronate
Placebo Comparator: 2
Arm #2 will include patients randomized to receive placebo therapy for 24 months
Drug: Placebo
identical placebo pill once weekly for 24 months
Other Name: Placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687661

Locations
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Karen E Yeates, Dr Queen's University
  More Information

No publications provided

Responsible Party: Karen Yeates, Dr Karen E. Yeates, Department of Medicine Queen's University., Queen's University
ClinicalTrials.gov Identifier: NCT00687661     History of Changes
Other Study ID Numbers: QUICK Study, J.P.Bickell Foundation Grant, 8 April 2005
Study First Received: May 28, 2008
Last Updated: September 30, 2013
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
Chronic Kidney Failure
Vascular Calcification
Bisphosphonates

Additional relevant MeSH terms:
Calcinosis
Kidney Diseases
Kidney Failure, Chronic
Vascular Calcification
Renal Insufficiency, Chronic
Calcium Metabolism Disorders
Metabolic Diseases
Urologic Diseases
Renal Insufficiency
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014