Queen's University Investigation of Calcification in Chronic Kidney Disease

NCT00687661 | Completed Phase 3 DMC

• 3 other identifiers: QUICK StudyJ.P.Bickell Foundation Grant8 April 2005
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney Failure; Vascular Calcification; Bisphosphonates

Outcome Measures

Primary Outcomes (1)

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

  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.

  24 months

Study Arms (2)

1

ACTIVE COMPARATOR

Arm #1 will include patients randomized to receive bisphosphonate therapy for 24 months.

Drug: Bisphosphonate

2

PLACEBO COMPARATOR

Arm #2 will include patients randomized to receive placebo therapy for 24 months

Drug: Placebo

Interventions

Bisphosphonate DRUG

35mg given orally once weekly for 24 months

Also known as: Residronate

1

Placebo DRUG

identical placebo pill once weekly for 24 months

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• receiving maintenance renal replacement therapy for less than 12 months
• incident patients starting renal replacement therapy for the first time

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic; Vascular Calcification

Interventions

Diphosphonates

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Karen E Yeates, Dr

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Karen E. Yeates, Department of Medicine Queen's University.

Study Record Dates

• First Submitted: May 28, 2008
• First Posted: June 2, 2008
• Study Start: October 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 28, 2015

Record last verified: 2015-09

Locations

CA (1)