Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00936078




Registration number
NCT00936078
Ethics application status
Date submitted
7/07/2009
Date registered
9/07/2009
Date last updated
6/08/2024

Titles & IDs
Public title
The Living Kidney Donor Safety Study
Scientific title
The Living Kidney Donor Safety Study (Long-term Effects of Becoming a Living Kidney Donor)
Secondary ID [1] 0 0
6056 (15974E)
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 - 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:

1. Standard criteria donors (meet all screening criteria)
2. 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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hypertension
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)
Secondary outcome [1] 0 0
Kidney Function
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)
Secondary outcome [2] 0 0
Albuminuria
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)
Secondary outcome [3] 0 0
Hypertension, an eGFR<60, and/or albuminuria
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)

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
Minimum age
18 Years
Maximum age
70 Years
Sex
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-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)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2022
Sample size
Target
Accrual to date
Final
1438
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
Government body
Name [1] 0 0
Canadian Institutes of Health Research (CIHR)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Astellas Pharma Canada, Inc.
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/industry
Name [3] 0 0
Novartis
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amit Garg, PhD, MD
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results not provided in https://clinicaltrials.gov/study/NCT00936078