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

This study has been completed.
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00951977
First received: July 31, 2009
Last updated: March 10, 2017
Last verified: March 2017
  Purpose
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.

Condition
End Stage Renal Disease Transplantation

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Live Kidney Donor Study - Cross-Sectional and Historical Cohort Study

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Prevalence and incidence of hypertension, proteinuria, renal disease, and anemia [ Time Frame: Since donation ]
  • Prevalence and incidence of cardiovascular disease as manifested by myocardial infarction (MI), heart failure (HF), stroke, and CABG/PTCA [ Time Frame: Since donation ]
  • Quality of life and insurance status [ Time Frame: Since donation ]

Secondary Outcome Measures:
  • Incidence of hypertension, proteinuria, renal disease, anemia, and QOL in black and white donors. [ Time Frame: Since donation ]
  • Incidence of hypertension, proteinuria, renal disease, anemia, and QOL in donors with open nephrectomy and in donors with laparoscopic nephrectomy. [ Time Frame: Since donation ]
  • The operative morbidity in living kidney donors with open nephrectomy and in donors with laparoscopic nephrectomy. [ Time Frame: Since donation ]
  • Incidence of hypertension, proteinuria, renal disease, anemia, and QOL in standard living kidney donors and extended criteria donors. [ Time Frame: 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. [ Time Frame: Since donation ]
  • The identification of donor family characteristics that correlated with living kidney donor risk for morbidity and renal disease. [ Time Frame: Retrospective ]
  • Donor physical health and recipient post-transplant course as it correlates with positive QOL scores and negative QOL scores. [ Time Frame: Since donation ]
  • Identify the predictors and correlates of donors' quality of life outcomes [ Time Frame: 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 [ Time Frame: After donation ]
  • Recipient outcomes for donors participating in the study and those who decline to participate. [ Time Frame: After donation ]

Enrollment: 7029
Study Start Date: October 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Subjects who have formerly donated a kidney
Matched community control Subjects

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants who have either donated a kidney or control subjects who are matched to have similar demographics and health condition a donor in the study.
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951977

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
National Heart, Lung, and Blood Institute (NHLBI)
Health Resources and Services Administration (HRSA)
Investigators
Principal Investigator: Sandra J. Taler, MD Mayo Clinic, Division of Nephrology and Hypertension
  More Information

Additional Information:
Publications:

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: SDY290
ImmPort study identifier is SDY290
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: SDY290
ImmPort study identifier is SDY290
Study summary, -design, -demographics, -files.  This link exits the ClinicalTrials.gov site
Identifier: SDY290
ImmPort study identifier is SDY290

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00951977     History of Changes
Other Study ID Numbers: DAIT RELIVE-04
Study First Received: July 31, 2009
Last Updated: March 10, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
End Stage Renal Disease (ESRD)
Transplantation
Living Kidney Donation
Kidney Transplant

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on July 26, 2017