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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
7/07/2009
Date last updated
27/08/2018

Titles & IDs
Public title
Living Kidney Donor Study
Scientific title
Long-term Effects of Becoming a Living Kidney Donor Study
Secondary ID [1] 0 0
15974
Secondary ID [2] 0 0
R-09-117
Universal Trial Number (UTN)
Trial acronym
LKD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Living Kidney Donation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Non-donors/controls - People who have not donated a kidney.

Living Kidney Donors -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hypertension in kidney donors
Timepoint [1] 0 0
Annually for 5 years post donation

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
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
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)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Manitoba
Country [4] 0 0
Canada
State/province [4] 0 0
Nova Scotia
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Other
Name
Lawson Health Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Canadian Institutes of Health Research (CIHR)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00936078
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amit Garg, MD, MA, FRCPC, FACP
Address 0 0
London Health Sciences Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jennifer Arnold, BA, BSc
Address 0 0
Country 0 0
Phone 0 0
519-685-8147
Fax 0 0
Email 0 0
Jennifer.Arnold@lhsc.on.ca
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00936078