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Living Kidney Donor Study (LKD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00936078
Recruitment Status : Active, not recruiting
First Posted : July 9, 2009
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Amit Garg, Lawson Health Research Institute

Brief Summary:
Living kidney donors and non-donor controls will be studied before and after the living donor transplant. The donor and non-donor will be followed for up to 5 years. The purpose of this study is to see if there are any differences between the two groups in regards to blood pressure, rate of hypertension, kidney function and psychological well being and economical status.

Condition or disease
Living Kidney Donation

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, proteinuria, reduced kidney function, 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 community. 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.

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Study Type : Observational
Actual Enrollment : 1442 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Effects of Becoming a Living Kidney Donor Study
Study Start Date : June 2009
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Group/Cohort
Non-donors/controls
People who have not donated a kidney.
Living Kidney Donors



Primary Outcome Measures :
  1. Hypertension in kidney donors [ Time Frame: Annually for 5 years post donation ]

Biospecimen Retention:   Samples With DNA
Serum Urine


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

  • Be able to speak and read English and/or French, and
  • Be able to provide informed consent, and
  • Be between the ages of 18 - 70

AND

Subjects must either:

  • Be approved by the LHSC team (or applicable medical team at the participating sites) as eligible to donate their kidney,

OR

  • Meet study eligibility for controls (non-donors) as follows:
  • Meet blood pressure criteria as follows;
  • Blood pressure < 140 mmHg systolic and < 90 mmHg diastolic based on an average of last 3 blood pressure measurements taken during the interview, or Average blood pressure < 140 mmHg systolic and < 90 mmHg diastolic based on a minimum of 12 readings taken at home.
  • Meet local lab criteria as follows;
  • Documented pre-donation serum creatinine < 115µmol/L (1.3 mg/dL) in men or < 90µmol/L (1.0mg/dL) in women, or Cockcroft-Gault estimated glomerular filtration rate > 80 mL/min.
  • Urine dipstick test for protein is negative or a random urine albumin to creatinine ratio < 8 mg/mmol (70 mg/g)
  • Urine dipstick test for hematuria is negative. Test should not occur during menses, and test should be repeated if there is evidence of urinary tract infection.
  • Have a Body mass index of < 35 kg/m2

Exclusion Criteria:

  • Be involved in another clinical study that would affect the outcome of this study.

AND

  • Control (non-donors)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 hr fast, or a two hour oral glucose test of 11.1 mmol/L, or
  • Have a history of diabetes during pregnancy
  • Have been symptomatic for kidney stones any time in the past 3 years
  • Have a known contraindication to anesthesia or surgery, or
  • Be currently pregnant or have been pregnant in the past month, or
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00936078


Locations
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Australia
Sir Charles Gairdner Hospital
Perth, Australia
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
Queen Elizabeth II Hospital
Halifax, Nova Scotia, Canada
Canada, Ontario
St. Joseph's Hospital
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
The Ottawa Hospital
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Canada, Quebec
The Montreal General Hospital
Montreal, Quebec, Canada
Sponsors and Collaborators
Lawson Health Research Institute
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Amit Garg, MD, MA, FRCPC, FACP London Health Sciences Centre
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amit Garg, Associate Professor, Medicine; Consultant Nephrology LHSC (as of July 1, 2003), Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00936078    
Other Study ID Numbers: R-09-117
15974 ( Other Identifier: REB )
First Posted: July 9, 2009    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Keywords provided by Amit Garg, Lawson Health Research Institute:
kidney transplantation
cohort study
qualitative research
health services research
hypertension