Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00936078
Registration number
NCT00936078
Ethics application status
Date submitted
7/07/2009
Date registered
9/07/2009
Date last updated
5/12/2022
Titles & IDs
Public title
The Living Kidney Donor Safety Study
Query!
Scientific title
The Living Kidney Donor Safety Study (Long-term Effects of Becoming a Living Kidney Donor)
Query!
Secondary ID [1]
0
0
6056 (15974E)
Query!
Secondary ID [2]
0
0
R-09-117
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
LKD
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Living Kidney Donation
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
Non-donors/controls - Healthy normotensive people who have not donated a kidney including relatives or friends of the donor, or candidates who were ineligible to donate due to blood group or cross-match incompatibility. These non-donor/controls must meet all screening criteria (same as standard criteria donors).
Living Kidney Donors - Living kidney donors who went on to donate their kidney. All donors were recruited and are divided into 2 groups:
Standard criteria donors (meet all screening criteria)
Expanded-criteria donors (did not meet one or more of the screening criteria)
Expanded criteria donors will be examined in a separate protocol and analysis.
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Hypertension
Query!
Assessment method [1]
0
0
Incident hypertension will be adjudicated by a physician who is blinded to the participant's donation status. Adjudication will occur if a participant meets the following criteria in follow-up: (1) the participant reports a physician diagnosis of hypertension, (2) the participant reports taking medication for hypertension, or (3) the participant has a systolic blood pressure (SBP) =140 or a diastolic blood pressure (DBP) =90 mmHg based on the average blood pressure (BP) measurements at any follow-up visit. Stage 1 hypertension will be defined as SBP/DBP 130 to 139/80 to 89 mmHg. We will also assess the average change in SBP and DBP over time accounting for the use of antihypertensive medications. Donors with pre-donation hypertension will be excluded from this primary analysis.
Query!
Timepoint [1]
0
0
Annually (one data collection per year) for a minimum of 5 years to a maximum of 15 years after donation (baseline)
Query!
Secondary outcome [1]
0
0
Kidney Function
Query!
Assessment method [1]
0
0
We will assess the annualized change in eGFR over time (in mL/min per 1.73 m2 per year) in donors and non-donors using all available eGFR measurements, setting the starting eGFR value to be the one obtained (1) 1 year after the nephrectomy date (or 1 year after the assigned nephrectomy date for non-donors), (2) 3 years after the nephrectomy date, and (3) at baseline (pre-donation). We will also examine the proportion of participants whose eGFR fell below 60 mL/min per 1.73 m2 in follow-up, the proportion whose eGFR fell below 45 mL/min per 1.73 m2, and the proportion whose eGFR fell below 30 mL/min per 1.73 m2.
Query!
Timepoint [1]
0
0
Annually (one data collection per year) for a minimum of 5 years to a maximum of 15 years after donation (baseline)
Query!
Secondary outcome [2]
0
0
Albuminuria
Query!
Assessment method [2]
0
0
We will compare the geometric mean albumin-to-creatinine ratio in donors versus non-donors at the final follow-up visit, adjusted for the baseline (pre-donation) value. Values that are too low to measure will be recoded as 0.2 mg/mmol. We will also examine the proportion of participants who have an albumin-to-creatinine ratio =3 mg/mmol (=30 mg/g) or >30 mg/mmol (>300 mg/g) at any time in follow-up.
Query!
Timepoint [2]
0
0
Annually (one data collection per year) for a minimum of 5 years to a maximum of 15 years after donation (baseline)
Query!
Secondary outcome [3]
0
0
Hypertension, an eGFR<60, and/or albuminuria
Query!
Assessment method [3]
0
0
We will examine the proportion of participants who develop hypertension, an eGFR <60 mL/min per 1.73 m2, or an albumin-to-creatinine ratio =3 mg/mmol. This outcome will be assessed as a composite, with death (expected to be rare during the follow-up period) treated as a competing event. We will also report the proportions of participants who develop (1) 2 or 3 of these components and (2) all 3 of these components.
Query!
Timepoint [3]
0
0
Annually (one data collection per year) for a minimum of 5 years to a maximum of 15 years after donation (baseline)
Query!
Eligibility
Key inclusion criteria
- Be able to speak and read English and/or French, and
- Be able to provide informed consent, and
AND
Subjects must either:
- Be approved by the LHSC team (or applicable medical team at the participating sites)
as eligible to donate their kidney and donated a kidney,
OR
- Meet study eligibility for controls (non-donors) as follows:
Be between the ages of 18 and 70 years
Meet blood pressure criteria as follows:
- Blood pressure <140 mmHg systolic and <90 mmHg diastolic based on an average of at
least 3 blood pressure measurements taken during the recruitment interview, or an
average blood pressure < 140 mmHg systolic and < 90 mmHg diastolic based on a minimum
of 12 readings taken at home.
- All participants need to successfully record at least 12 home blood pressure readings
using the self-monitoring device to be eligible
Meet local lab criteria as follows:
- Documented pre-donation serum creatinine <115 µmol/L in men or <90 µmol/L in women, or
Cockcroft-Gault estimated glomerular filtration rate >80 mL/min
- Urine dipstick test for protein is negative or if trace or 0.3 g/L, a random urine
albumin to creatinine ratio <8 mg/mmol (70 mg/g)
- Urine dipstick test for hematuria is negative. Those with non-persistent hematuria are
eligible to participate. Those with initial evidence of dipstick hematuria may have a
second assessment. Test should not occur during menses. Test should be repeated if
there is evidence of urinary tract infection once treated.
- Have a body mass index of <35 kg/m2
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
70
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
- Be involved in another clinical study that would affect the outcome of this study.
AND
Control (non-donor) 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 hour fast (if available), or a two hour
oral glucose test of >11.1 mmol/L (if available), or have a history of diabetes during
pregnancy
- Have been symptomatic or had evidence of kidney stones any time in the past 3 years
- Have a known contraindication to anesthesia or surgery
- Be currently pregnant or have been pregnant in the past month
- 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, diabetes)
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/09/2009
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/03/2022
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1438
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Sir Charles Gairdner Hospital - Perth
Query!
Recruitment postcode(s) [1]
0
0
- Perth
Query!
Recruitment outside Australia
Country [1]
0
0
Canada
Query!
State/province [1]
0
0
Alberta
Query!
Country [2]
0
0
Canada
Query!
State/province [2]
0
0
British Columbia
Query!
Country [3]
0
0
Canada
Query!
State/province [3]
0
0
Manitoba
Query!
Country [4]
0
0
Canada
Query!
State/province [4]
0
0
Nova Scotia
Query!
Country [5]
0
0
Canada
Query!
State/province [5]
0
0
Ontario
Query!
Country [6]
0
0
Canada
Query!
State/province [6]
0
0
Quebec
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Lawson Health Research Institute
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Canadian Institutes of Health Research (CIHR)
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Commercial sector/Industry
Query!
Name [2]
0
0
Astellas Pharma Canada, Inc.
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Other collaborator category [3]
0
0
Commercial sector/Industry
Query!
Name [3]
0
0
Novartis
Query!
Address [3]
0
0
Query!
Country [3]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The main goal of this study is to understand the long-term effects of kidney donation on
blood pressure, kidney function, and patient-reported health-related quality of life. Living
kidney donors and non-donor controls will be studied before and after the living donor
transplant. The donors and non-donors will be followed for a minimum of 5 years and a maximum
of 15 years. Both groups will be made up of healthy normotensive adults. The purpose of this
study is to see if there are any long-term differences between the two groups regarding:
1. risk of hypertension
2. rate of kidney decline
3. risk of albuminuria
4. changes in health-related quality of life
The study also looks to assess other outcomes, including:
1. understand and quantify the expenses incurred by donors
2. understand donor factors which influence recipient outcomes
The pilot version of this study was started in 2004. Donors and controls in the pilot study
were given the opportunity to continue on in the main study once it started in 2009.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00936078
Query!
Trial related presentations / publications
Garg AX, Arnold JB, Cuerden M, Dipchand C, Feldman LS, Gill JS, Karpinski M, Klarenbach S, Knoll GA, Lok C, Miller M, Monroy-Cuadros M, Nguan C, Prasad GVR, Sontrop JM, Storsley L, Boudville N. The Living Kidney Donor Safety Study: Protocol of a Prospective Cohort Study. Can J Kidney Health Dis. 2022 Oct 28;9:20543581221129442. doi: 10.1177/20543581221129442. eCollection 2022.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Amit Garg, PhD, MD
Query!
Address
0
0
London Health Sciences Centre
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00936078
Download to PDF