Status:
COMPLETED
The Living Kidney Donor Safety Study
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Astellas Pharma Canada, Inc.
Conditions:
Living Kidney Donation
Eligibility:
All Genders
18-70 years
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 ...
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 improv...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
September 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
1438 Patients enrolled
Trial Details
Trial ID
NCT00936078
Start Date
September 1 2009
End Date
March 1 2022
Last Update
August 6 2024
Active Locations (13)
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1
Sir Charles Gairdner Hospital
Perth, Australia
2
Foothills Medical Centre
Calgary, Alberta, Canada
3
University of Alberta
Edmonton, Alberta, Canada
4
St. Paul's Hospital
Vancouver, British Columbia, Canada