Living Kidney DonationLKDNCT00936078
The Living Kidney Donor Safety Study
An observational study of Living Kidney Donation, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 13 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Living Kidney Donation
- How many people
- 1,438 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Sep 2009to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The donors will come from the identified population of people who will be donating their kidney at the hospital sites participating in this study. The non-donor population will be people who the donors identify and ask to act as their control person. As well, controls will also be found using pamphlet and poster board advertising.
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Canada12 sites
Foothills Medical Centre
Calgary, Alberta
University of Alberta
Edmonton, Alberta
Queen Elizabeth II Hospital
Halifax, Nova Scotia
St. Joseph's Hospital
Hamilton, Ontario
London Health Sciences Centre
London, Ontario, N6A 5W9
The Montreal General Hospital
Montreal, Quebec
The Ottawa Hospital
Ottawa, Ontario
St. Michael's Hospital
Toronto, Ontario
University Health Network
Toronto, Ontario
St. Paul's Hospital
Vancouver, British Columbia
Vancouver General Hospital
Vancouver, British Columbia
Health Sciences Centre
Winnipeg, Manitoba
About this study
Official title: The Living Kidney Donor Safety Study (Long-term Effects of Becoming a Living Kidney Donor)
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:
- risk of hypertension
- rate of kidney decline
- risk of albuminuria
- changes in health-related quality of life
Read more
The study also looks to assess other outcomes, including:
- understand and quantify the expenses incurred by donors
- 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.
Read the detailed description
Transplantation is the preferred treatment option for patients with kidney failure. Compared to dialysis, patients who receive a transplant have a substantial reduction in the risk of death, an improved quality of life, and decreased health care costs. The demand for kidneys has resulted in long waiting lists for deceased donor kidneys. Therefore, living kidney donations have been on the increase over the years in order to meet this demand for kidneys. Living donation also has the added benefit of a shorter waiting time, increased graft success and increased recipient survival compared to deceased donor transplantation.
Aside from the advantages for the recipient, living transplantation is a complex medical practice which we must conduct in a safe and ethical manner. The premise for accepting living donors is that the "minimal" risk of short and long-term medical harm realized by the donor is outweighed by the definite advantages to the recipient and potential psychosocial benefits of altruism to the donor. The short-term potential medical consequences for living kidney donors have been well established. Yet, the long-term implications of living kidney donation are far less certain. Potential medical risks include hypertension, reduced kidney function, albuminuria, premature cardiovascular disease, and death. Estimates of these outcomes vary substantially in the literature. As well, the potential long-term medical risks are also communicated inconsistently across transplant communities. It is accepted that most living donors experience increased self-esteem, feelings of well-being and an improved quality of life after their altruistic act. However, some donors have negative psychosocial outcomes which require further clarification. There is also a financial burden to the donor from the donation process. Concerns about future life, disability, and medical insurance have been raised. These issues will be addressed through this research study on the long term implications of donation. A better understanding of post-donation risk and the timing of new disease onset is critical for donor selection, informed consent, and follow-up. The study will assess the attributable risk of living kidney donation using study techniques that meet modern criteria for high methodological quality. Non-donors will have similar indicators of baseline health as donors and will complete the same schedule of follow-up assessments.
Data was collected as follows:
- Pre-donation/baseline (informed consent was obtained, eligibility was assessed, surveys were completed, a basic physical exam was completed, blood and urine samples were collected and training on the home blood pressure machine was completed). This occurred for both donors and non-donor controls either on site or long distance.
- Three months post-donation (mailed 3 month surveys)
- Annual post-donation follow-up visits (mailed surveys and blood pressure machine, lab testing completed). The number of annual follow-up visits varied depending on the year of nephrectomy, or simulated nephrectomy year for controls (between 5 years to 15 years)
Living kidney donation is practiced with the expectation that minimal risks of donor harm are outweighed by psychological benefits of altruism to the donor and improved recipient health. Our multicentre prospective cohort study of living kidney donors will inform the practice and safety of living kidney donation, including transplant center medical policies on donor selection, patient counseling, informed consent, and long-term patient follow-up and care.
- Conditions
- Living Kidney Donation
- Keywords
- blood pressure, glomerular filtration rate, hypertension, kidney transplantation, living kidney donation, unilateral nephrectomy
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypertension
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.
Measured: Annually (one data collection per year) for a minimum of 5 years to a maximum of 15 years after donation (baseline)
Secondary outcomes (3)
Kidney Function
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.
Measured: Annually (one data collection per year) for a minimum of 5 years to a maximum of 15 years after donation (baseline)
Albuminuria
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.
Measured: Annually (one data collection per year) for a minimum of 5 years to a maximum of 15 years after donation (baseline)
Hypertension, an eGFR<60, and/or albuminuria
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.
Measured: Annually (one data collection per year) for a minimum of 5 years to a maximum of 15 years after donation (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionNov 2021
- Study completionMar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Living Kidney DonationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,438 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Astellas Pharma Canada, Inc., Novartis
- Responsible party
- Principal investigator, Amit Garg, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Amit Garg, PhD, MD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936078
- Sponsor's protocol ID
- R-09-117
- Other IDs
- 6056 (15974E)
- Acronym
- LKD
- Status last verified
- Aug 2024
- First submitted
- 7 Jul 2009
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 36325263Garcia-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.
PubMed 34394947Habbous 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.
PubMed 29580662Przech 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.
PubMed 30404908Barnieh 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.
PubMed 31246933Garcia-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.
PubMed 31367455Barnieh 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.
PubMed 33741846Barnieh 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.
PubMed 29215180Garg 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.
PubMed 38780499
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Living Kidney Donor Safety Study (Long-term Effects of Becoming a Living Kidney Donor)
- ClinicalTrials.gov ID
- NCT00936078
- Acronym / sponsor ID
- LKD / R-09-117
- Conditions
- Living Kidney Donation
- Keywords
- blood pressure, glomerular filtration rate, hypertension, kidney transplantation, living kidney donation, unilateral nephrectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,438 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Astellas Pharma Canada, Inc., Novartis
- Study start
- Sep 2009 (actual)
- Primary completion
- Nov 2021 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 9 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- risk of hypertension
- rate of kidney decline
- risk of albuminuria
- changes in health-related quality of life
The study also looks to assess other outcomes, including:
- understand and quantify the expenses incurred by donors
- 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.
Detailed description
Transplantation is the preferred treatment option for patients with kidney failure. Compared to dialysis, patients who receive a transplant have a substantial reduction in the risk of death, an improved quality of life, and decreased health care costs. The demand for kidneys has resulted in long waiting lists for deceased donor kidneys. Therefore, living kidney donations have been on the increase over the years in order to meet this demand for kidneys. Living donation also has the added benefit of a shorter waiting time, increased graft success and increased recipient survival compared to deceased donor transplantation.
Aside from the advantages for the recipient, living transplantation is a complex medical practice which we must conduct in a safe and ethical manner. The premise for accepting living donors is that the "minimal" risk of short and long-term medical harm realized by the donor is outweighed by the definite advantages to the recipient and potential psychosocial benefits of altruism to the donor. The short-term potential medical consequences for living kidney donors have been well established. Yet, the long-term implications of living kidney donation are far less certain. Potential medical risks include hypertension, reduced kidney function, albuminuria, premature cardiovascular disease, and death. Estimates of these outcomes vary substantially in the literature. As well, the potential long-term medical risks are also communicated inconsistently across transplant communities. It is accepted that most living donors experience increased self-esteem, feelings of well-being and an improved quality of life after their altruistic act. However, some donors have negative psychosocial outcomes which require further clarification. There is also a financial burden to the donor from the donation process. Concerns about future life, disability, and medical insurance have been raised. These issues will be addressed through this research study on the long term implications of donation. A better understanding of post-donation risk and the timing of new disease onset is critical for donor selection, informed consent, and follow-up. The study will assess the attributable risk of living kidney donation using study techniques that meet modern criteria for high methodological quality. Non-donors will have similar indicators of baseline health as donors and will complete the same schedule of follow-up assessments.
Data was collected as follows:
- Pre-donation/baseline (informed consent was obtained, eligibility was assessed, surveys were completed, a basic physical exam was completed, blood and urine samples were collected and training on the home blood pressure machine was completed). This occurred for both donors and non-donor controls either on site or long distance.
- Three months post-donation (mailed 3 month surveys)
- Annual post-donation follow-up visits (mailed surveys and blood pressure machine, lab testing completed). The number of annual follow-up visits varied depending on the year of nephrectomy, or simulated nephrectomy year for controls (between 5 years to 15 years)
Living kidney donation is practiced with the expectation that minimal risks of donor harm are outweighed by psychological benefits of altruism to the donor and improved recipient health. Our multicentre prospective cohort study of living kidney donors will inform the practice and safety of living kidney donation, including transplant center medical policies on donor selection, patient counseling, informed consent, and long-term patient follow-up and care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The donors will come from the identified population of people who will be donating their kidney at the hospital sites participating in this study. The non-donor population will be people who the donors identify and ask to act as their control person. As well, controls will also be found using pamphlet and poster board advertising.
Key inclusion criteria (16 listed)
- Be able to speak and read English and/or French, and
- Be able to provide informed consent, and
- AND
- 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
Key exclusion criteria (12 listed)
- Be involved in another clinical study that would affect the outcome of this study.
- AND
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hypertension
Time frame: Annually (one data collection per year) for a minimum of 5 years to a maximum of 15 years after donation (baseline)
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.
3 secondary outcomes
Kidney Function
Time frame: Annually (one data collection per year) for a minimum of 5 years to a maximum of 15 years after donation (baseline)
Albuminuria
Time frame: Annually (one data collection per year) for a minimum of 5 years to a maximum of 15 years after donation (baseline)
Hypertension, an eGFR<60, and/or albuminuria
Time frame: Annually (one data collection per year) for a minimum of 5 years to a maximum of 15 years after donation (baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Background: PubMed 36325263Garg 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.
- Results publication: PubMed 34394947Garcia-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.
- Results publication: PubMed 29580662Habbous 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.
- Results publication: PubMed 30404908Przech 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.
- Results publication: PubMed 31246933Barnieh 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.
- Results publication: PubMed 31367455Garcia-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.
- Results publication: PubMed 33741846Barnieh 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.
- Results publication: PubMed 29215180Barnieh 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.
- Results publication: PubMed 38780499Garg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Garg, PhD, MD principal investigator
London Health Sciences Centre
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Living Kidney Donation, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypertension (time frame: Annually (one data collection per year) for a minimum of 5 years to a maximum of 15 years after donation (baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00936078, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.