Live Kidney Donor Study - Cross-Sectional and Historical Cohort Study

Study Overview
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Brief Summary
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Kidney transplantation from living donors has been shown to carry many benefits over deceased donor transplantation. Because of benefits such as shorter waiting times and improved outcome for transplant recipients, living kidney donation accounts for an increasing number of kidney transplants nationwide. Most published studies about living kidney donation demonstrate that the procedure is safe, but they also emphasize concerns that long-term data on live donor outcomes are insufficient. The purpose of this study is to assess the long term outcomes and risks that may arise from living kidney donation.

Detailed Description
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Living donor transplants provide several advantages over deceased donor kidneys, including a shorter waiting time. Living donor grafts also appear to have a lower rate of delayed graft function and improved long-term recipient and graft survival. Most published studies of living kidney donation have supported that the donation process is relatively safe for the donor. However, these reports also emphasize concerns that comprehensive long-term data on U.S. live donor outcomes are insufficient. One concern is that current data may underestimate the true long-term morbidity and mortality of living kidney donation. Additionally, older studies might not apply to the current donor population that includes older and more obese individuals. This is an observational study to look at the long term outcomes in living kidney donors. This study also seeks to find out if living kidney donors are at higher risk for certain conditions when compared to people of similar backgrounds who have not donated a kidney. Medical history, completed questionnaires, and blood and urine tests will be collected from donors and non donors. The compiled data from donors and non donors will be compared. Risks for diseases related to the kidney, heart, and blood vessels will be examined between the two groups. Quality of life and health insurance status will also be compared. The study will be conducted in 2 phases. All donors who donated a kidney between 5 and 50 years ago at one of the three study transplant centers will be asked to take part in Phase 1. Phase 1 aims to collect limited medical information using a short questionnaire. Phase 2 will include Phase 1 donors who agree to further assessments and matched community control participants. Participants in Phase 2 will be asked to complete more in-depth questionnaires on health status and quality of life. Phase 2 also involves height, weight, and blood pressure measurements. Blood and urine will be collected for this study if the participant does not have the necessary tests within 3 years of study participation. Seven thousand-eight hundred-sixty four (7864) previous kidney donors and about two thousand-five hundred (2500) control subjects will be asked to take part in this study. Participants will be recruited for this study over a 2.5.

Official Title
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Live Kidney Donor Study - Cross-Sectional and Historical Cohort Study

Conditions
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End Stage Renal Disease, Transplantation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Underwent a unilateral donor nephrectomy between 5 and 50 years ago; but no later than June 30, 2005 Alive at the time of study recruitment Exclusion Criteria: Inability to contact donor Community Control Inclusion Criteria: Matched to donor as healthy subject with a medical encounter date within 5 years of the date of donation and alive at the time of study recruitment Same gender as donor Same race as donor Matched by age, not to differ by more than 2 years Matched by BMI, not to differ by more than 5 kg/m^2 (JHS only) Community Control Exclusion Criteria: Inability to contact control participant Inability or unwillingness to provide informed consent Hypertension or identified Charlson comorbidity index variable diagnosed prior to or on the encounter date matched to the donor date of donation (REP only)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects who have formerly donated a kidney<br> | |
| Matched community control Subjects<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence and incidence of hypertension, proteinuria, renal disease, and anemia |  | Since donation | 
| Prevalence and incidence of cardiovascular disease as manifested by myocardial infarction (MI), heart failure (HF), stroke, and CABG/PTCA |  | Since donation | 
| Quality of life and insurance status |  | Since donation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hypertension, proteinuria, renal disease, anemia, and QOL in black and white donors. |  | Since donation | 
| Incidence of hypertension, proteinuria, renal disease, anemia, and QOL in donors with open nephrectomy and in donors with laparoscopic nephrectomy. |  | Since donation | 
| The operative morbidity in living kidney donors with open nephrectomy and in donors with laparoscopic nephrectomy. |  | Since donation | 
| Incidence of hypertension, proteinuria, renal disease, anemia, and QOL in standard living kidney donors and extended criteria donors. |  | Since donation | 
| Incidence of hypertension, proteinuria, renal disease, anemia, and QOL in donors more than 20 years since donation and in donors between 5 and 20 years since donation. |  | Since donation | 
| The identification of donor family characteristics that correlated with living kidney donor risk for morbidity and renal disease. |  | Retrospective | 
| Donor physical health and recipient post-transplant course as it correlates with positive QOL scores and negative QOL scores. |  | Since donation | 
| Identify the predictors and correlates of donors' quality of life outcomes |  | Throughout study | 
| Compare post-donation blood pressures, estimated glomerular filtration rate (GFR), urine protein levels and hemoglobin levels with those derived from population-based studies and matched community control participants |  | After donation | 
| Recipient outcomes for donors participating in the study and those who decline to participate. |  | After donation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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End Stage Renal Disease (ESRD), Transplantation, Living Kidney Donation, Kidney Transplant