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Live Kidney Donor Study

This study has been completed.
Sponsor:
Collaborators:
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00608283
First received: February 5, 2008
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

Kidney transplants from living donors now account for 40% of all the kidney transplants done in the United States. However, the current information on how donating a kidney can affect the donor's long term health needs further investigation. The purpose of this study is to collect data on a large number of live kidney donors and create and analyze a comprehensive database. Information about the number of living kidney donors, including those who have experienced kidney failure, heart problems, and death will be gathered for the database. Investigators will then use the database to identify the risks of kidney failure, associated conditions, and death after living donation. The database will also be used to identify characteristics that put donors at higher risk for health problems after donation.


Condition
Kidney Transplantation
End Stage Renal Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Live Kidney Donor Study (RELIVE-01)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Overall mortality [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Cause-specific mortality [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • End stage renal disease as defined in the protocol [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular and renal morbidity [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • 6 months incidence of adverse events [ Time Frame: At 6 months after kidney donation ] [ Designated as safety issue: No ]

Enrollment: 8951
Study Start Date: August 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Live Kidney Donors
People who are going to donate a kidney at one of the three transplant centers from August 2007 until June 2011

Detailed Description:

Kidney transplantation is the preferred treatment to dialysis for most people with kidney failure. However, the current waiting time to receive a kidney from a deceased donor is greater than 5 years in some parts of the United States. Kidneys from living donors have increased the number of kidneys available for transplantation and decreased the waiting period for those needing a transplant. Living kidney donation also provides several advantages over deceased donor kidneys, including more timely transplantation and longer function of the transplanted kidney. Despite these facts, there is inadequate information about whether living kidney donation may have serious adverse effects on the donor's health. Long-term data on the health risks of living donation are needed.

The purpose of this study is to establish and analyze a database of information on living donors who have or are going to donate a kidney at three transplant centers with longstanding live kidney donation programs through June 2011. Donor and recipient characteristics as well as specific data on kidney failure, heart disease, and death will be collected. National databases such as the Scientific Registry of Transplant Recipients, the Social Security Death Master File, the National Death Index and records maintained by the Centers for Medicare and Medicaid Services for patients with end stage renal disease (ESRD) will be used to supplement data provided by the participating transplant centers. After establishing the database, researchers expect to 1) determine the long-term risk of live kidney donation and 2) identify donor characteristics associated with higher risk for health problems after donation. Death, cause of death, and incidence of ESRD will be compared to those rates reported by the Centers for Disease Control and Prevention for the U.S. population during the same time period.

There will be no study visits for this study. Investigators will gather data from the medical charts of all live kidney donors from the three transplant centers through June 2011.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

People who will donate kidneys at one of the three transplant centers between August 2007 and June 2011

Criteria

Inclusion Criteria:

  • Donated kidney at one of the three participating study centers

Exclusion Criteria:

  • None
  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: NCT00608283

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
Health Resources and Services Administration (HRSA)
Investigators
Principal Investigator: Sandra J. Taler, MD Division of Nephrology and Hypertension, Mayo Clinic
Principal Investigator: Clifton Kew, MD University of Alabama at Birmingham
Principal Investigator: Hassan Ibrahim, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00608283     History of Changes
Other Study ID Numbers: DAIT RELIVE-01
Study First Received: February 5, 2008
Last Updated: December 11, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Kidney transplant
Live donor transplant

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

ClinicalTrials.gov processed this record on November 25, 2014