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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/show/NCT00936078
Registration number
NCT00936078
Ethics application status
Date submitted
7/07/2009
Date registered
9/07/2009
Date last updated
2/09/2020
Titles & IDs
Public title
Living Kidney Donor Study
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Scientific title
Long-term Effects of Becoming a Living Kidney Donor Study
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Secondary ID [1]
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15974
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Secondary ID [2]
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R-09-117
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Universal Trial Number (UTN)
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Trial acronym
LKD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Living Kidney Donation
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Non-donors/controls - People who have not donated a kidney.
Living Kidney Donors -
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Hypertension in kidney donors
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Timepoint [1]
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Annually for 5 years post donation
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Eligibility
Key inclusion criteria
- Be able to speak and read English and/or French, and
- Be able to provide informed consent, and
- Be between the ages of 18 - 70
AND
Subjects must either:
- Be approved by the LHSC team (or applicable medical team at the participating sites)
as eligible to donate their kidney,
OR
- Meet study eligibility for controls (non-donors) as follows:
- Meet blood pressure criteria as follows;
- Blood pressure < 140 mmHg systolic and < 90 mmHg diastolic based on an average of last
3 blood pressure measurements taken during the interview, or Average blood pressure <
140 mmHg systolic and < 90 mmHg diastolic based on a minimum of 12 readings taken at
home.
- Meet local lab criteria as follows;
- Documented pre-donation serum creatinine < 115µmol/L (1.3 mg/dL) in men or < 90µmol/L
(1.0mg/dL) in women, or Cockcroft-Gault estimated glomerular filtration rate > 80
mL/min.
- Urine dipstick test for protein is negative or a random urine albumin to creatinine
ratio < 8 mg/mmol (70 mg/g)
- Urine dipstick test for hematuria is negative. Test should not occur during menses,
and test should be repeated if there is evidence of urinary tract infection.
- Have a Body mass index of < 35 kg/m2
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Minimum age
18
Years
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Maximum age
70
Years
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Gender
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Be involved in another clinical study that would affect the outcome of this study.
AND
- Control (non-donors)subjects must not:
- Ever have received dialysis, even for a short period of time
- Ever have had a kidney transplant
- Be taking any hypertension class medication for any reason
- Have any history of hypertension, currently or in the past
- Have plasma glucose of >7 mmol/L after a 6 hr fast, or a two hour oral glucose test of
11.1 mmol/L, or
- Have a history of diabetes during pregnancy
- Have been symptomatic for kidney stones any time in the past 3 years
- Have a known contraindication to anesthesia or surgery, or
- Be currently pregnant or have been pregnant in the past month, or
- Have a medical condition that would prevent him or her from becoming a kidney donor
(e.g. History of renal disease, Permanent protein in urine, Cancer other than cured
non-melanoma skin cancer, Cardiovascular disease, Pulmonary disease)
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2021
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Actual
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Sample size
Target
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Accrual to date
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Final
1442
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Sir Charles Gairdner Hospital - Perth
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Recruitment postcode(s) [1]
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- Perth
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Alberta
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Country [2]
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Canada
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State/province [2]
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British Columbia
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Country [3]
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Canada
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State/province [3]
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Manitoba
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Country [4]
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Canada
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State/province [4]
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Nova Scotia
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Country [5]
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Canada
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State/province [5]
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Ontario
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Country [6]
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Canada
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State/province [6]
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Quebec
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Funding & Sponsors
Primary sponsor type
Other
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Name
Lawson Health Research Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Canadian Institutes of Health Research (CIHR)
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Living kidney donors and non-donor controls will be studied before and after the living donor
transplant. The donor and non-donor will be followed for up to 5 years. The purpose of this
study is to see if there are any differences between the two groups in regards to blood
pressure, rate of hypertension, kidney function and psychological well being and economical
status.
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Trial website
https://clinicaltrials.gov/show/NCT00936078
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Amit Garg, MD, MA, FRCPC, FACP
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Address
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London Health Sciences Centre
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary results
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Other publications
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