The Living Kidney Donor Safety Study
Condition: Living Kidney Donation
Study type: Observational

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 was started 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:

        1. 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.

        2. Three months post-donation (mailed 3 month surveys)

        3. 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.
    

Observational model: Cohort
Time perspective: Prospective
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.
      
Biospecimen description: 
      Serum Urine
    
Keywords: blood pressure; glomerular filtration rate; hypertension; kidney transplantation; living kidney donation; unilateral nephrectomy