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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
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 (The Long Term Medical and Psychological Implications of Becoming a Living Kidney Donor: A Prospective Pilot Study) began 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.
Trial website
https://clinicaltrials.gov/study/NCT00936078
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.
Garcia-Ochoa C, Feldman LS, Nguan C, Monroy-Caudros M, Arnold JB, Barnieh L, Boudville N, Cuerden MS, Dipchand C, Gill JS, Karpinski M, Klarenbach S, Knoll G, Lok CE, Miller M, Prasad GVR, Sontrop JM, Storsley L, Garg AX. Impact of Perioperative Complications on Living Kidney Donor Health-Related Quality of Life and Mental Health: Results From a Prospective Cohort Study. Can J Kidney Health Dis. 2021 Aug 11;8:20543581211037429. doi: 10.1177/20543581211037429. eCollection 2021.
Habbous S, Arnold J, Begen MA, Boudville N, Cooper M, Dipchand C, Dixon SN, Feldman LS, Gozdzik D, Karpinski M, Klarenbach S, Knoll GA, Lam NN, Lentine KL, Lok C, McArthur E, McKenzie S, Miller M, Monroy-Cuadros M, Nguan C, Prasad GVR, Przech S, Sarma S, Segev DL, Storsley L, Garg AX; Donor Nephrectomy Outcomes Research (DONOR) Network. Duration of Living Kidney Transplant Donor Evaluations: Findings From 2 Multicenter Cohort Studies. Am J Kidney Dis. 2018 Oct;72(4):483-498. doi: 10.1053/j.ajkd.2018.01.036. Epub 2018 Mar 24.
Przech S, Garg AX, Arnold JB, Barnieh L, Cuerden MS, Dipchand C, Feldman L, Gill JS, Karpinski M, Knoll G, Lok C, Miller M, Monroy M, Nguan C, Prasad GVR, Sarma S, Sontrop JM, Storsley L, Klarenbach S; Donor Nephrectomy Outcomes Research (DONOR) Network. Financial Costs Incurred by Living Kidney Donors: A Prospective Cohort Study. J Am Soc Nephrol. 2018 Dec;29(12):2847-2857. doi: 10.1681/ASN.2018040398. Epub 2018 Nov 7.
Barnieh L, Klarenbach S, Arnold J, Cuerden M, Knoll G, Lok C, Sontrop JM, Miller M, Ramesh Prasad GV, Przech S, Garg AX; Donor Nephrectomy Outcomes Research (DONOR) Network. Nonreimbursed Costs Incurred by Living Kidney Donors: A Case Study From Ontario, Canada. Transplantation. 2019 Jun;103(6):e164-e171. doi: 10.1097/TP.0000000000002685.
Garcia-Ochoa C, Feldman LS, Nguan C, Monroy-Cuadros M, Arnold J, Boudville N, Cuerden M, Dipchand C, Eng M, Gill J, Gourlay W, Karpinski M, Klarenbach S, Knoll G, Lentine KL, Lok CE, Luke P, Prasad GVR, Sener A, Sontrop JM, Storsley L, Treleaven D, Garg AX; Donor Nephrectomy Outcomes Research (DONOR) Network. Perioperative Complications During Living Donor Nephrectomy: Results From a Multicenter Cohort Study. Can J Kidney Health Dis. 2019 Jul 18;6:2054358119857718. doi: 10.1177/2054358119857718. eCollection 2019.
Barnieh L, Arnold JB, Boudville N, Cuerden MS, Dew MA, Dipchand C, Feldman LS, Gill JS, Karpinski M, Klarenbach S, Knoll G, Lok C, Miller M, Monroy M, Nguan C, Prasad GVR, Sontrop JM, Storsley L, Garg AX; Donor Nephrectomy Outcomes Research (DONOR) Network. Living Kidney Donors' Financial Expenses and Mental Health. Transplantation. 2021 Jun 1;105(6):1356-1364. doi: 10.1097/TP.0000000000003401.
Barnieh L, Kanellis J, McDonald S, Arnold J, Sontrop JM, Cuerden M, Klarenbach S, Garg AX, Boudville N; Donor Nephrectomy Outcomes Research (DONOR) Network. Direct and indirect costs incurred by Australian living kidney donors. Nephrology (Carlton). 2018 Dec;23(12):1145-1151. doi: 10.1111/nep.13205.
Garg AX, Arnold JB, Cuerden MS, Dipchand C, Feldman LS, Gill JS, Karpinski M, Klarenbach S, Knoll G, Lok CE, Miller M, Monroy-Cuadros M, Nguan C, Prasad GVR, Sontrop JM, Storsley L, Boudville N. Hypertension and Kidney Function After Living Kidney Donation. JAMA. 2024 Jul 23;332(4):287-299. doi: 10.1001/jama.2024.8523.
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



Summary Results

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