The Living Kidney Donor Safety Study

NCT00936078 | Completed DMC

• 2 other identifiers: R-09-1176056 (15974E)
• Study Type: observational
• Target: 1,438
• Locations: 2 countries
• Sites: 13

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. 1.risk of hypertension
2. 2.rate of kidney decline
3. 3.risk of albuminuria
4. 4.changes in health-related quality of life
5. 5.understand and quantify the expenses incurred by donors
6. 6.understand donor factors which influence recipient outcomes

Conditions

Living Kidney Donation

Keywords

blood pressure; glomerular filtration rate; hypertension; kidney transplantation; living kidney donation; unilateral nephrectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Annually (one data collection per year) for a minimum of 5 years to a maximum of 15 years after donation (baseline)

• Albuminuria

  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

  Annually (one data collection per year) for a minimum of 5 years to a maximum of 15 years after donation (baseline)

Other Outcomes (6)

• Death, kidney failure, and major cardiovascular events

  Annually (one data collection per year) for a minimum of 5 years to a maximum of 15 years after donation (baseline)

• Tinnitus (tracer outcome)

  Annually (one data collection per year) for a minimum of 5 years to a maximum of 15 years after donation (baseline)

• Physical component summary (PCS) score of the 36-Item Short Form Survey (SF-36)

  Annually (one data collection per year) for a maximum of 5 years, occurring up to a maximum of 15 years after donation (baseline)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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,
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Astellas Pharma Canada, Inc.: collaborator
• Novartis: collaborator

Study Sites (13)

Sir Charles Gairdner Hospital

Perth, Australia

Location

Foothills Medical Centre

Calgary, Alberta, Canada

Location

University of Alberta

Edmonton, Alberta, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

Health Sciences Centre

Winnipeg, Manitoba, Canada

Location

Queen Elizabeth II Hospital

Halifax, Nova Scotia, Canada

Location

St. Joseph's Hospital

Hamilton, Ontario, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

University Health Network

Toronto, Ontario, Canada

Location

The Montreal General Hospital

Montreal, Quebec, Canada

Location

Related Publications (9)

• 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.

  PMID: 36325263 BACKGROUND

• 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.

  PMID: 34394947 RESULT

• 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.

  PMID: 29580662 RESULT

• 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.

  PMID: 30404908 RESULT

• 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.

  PMID: 31246933 RESULT

• 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.

  PMID: 31367455 RESULT

• 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.

  PMID: 33741846 RESULT

• 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.

  PMID: 29215180 RESULT

• 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.

  PMID: 38780499 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Serum Urine

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Amit Garg, PhD, MD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean (Clinical Research - Schulich School of Medicine and Dentistry); Professor (Medicine - Western University); Nephrologist (London Health Sciences Centre); Director (ICES Western Facilitly) (As of October 19 2022)

Study Record Dates

• First Submitted: July 7, 2009
• First Posted: July 9, 2009
• Study Start: September 1, 2009
• Primary Completion: November 1, 2021
• Study Completion: March 1, 2022
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

AU (1); CA (12)