Queen's University Investigation of Calcification in Chronic Kidney Disease (QUICK)
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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 |
- Absolute change in coronary artery calcification score (CaSc) from baseline to study completion. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- 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 2012 |
| Estimated Primary Completion Date: | June 2012 (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 |
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 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: | October 12, 2011 |
| 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 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 May 16, 2013