Live Kidney Donor Study
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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: NCT00608283 |
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Recruitment Status :
Completed
First Posted : February 6, 2008
Last Update Posted : March 27, 2017
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| Condition or disease |
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| Kidney Transplantation End Stage Renal Disease |
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.
| Study Type : | Observational |
| Actual Enrollment : | 8951 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Live Kidney Donor Study (RELIVE-01) |
| Study Start Date : | August 2007 |
| Actual Primary Completion Date : | June 2011 |
| Actual Study Completion Date : | June 2011 |
| Group/Cohort |
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Live Kidney Donors
People who are going to donate a kidney at one of the three transplant centers from August 2007 until June 2011
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- Overall mortality [ Time Frame: Throughout study ]
- Cause-specific mortality [ Time Frame: Throughout study ]
- End stage renal disease as defined in the protocol [ Time Frame: Throughout study ]
- Cardiovascular and renal morbidity [ Time Frame: Throughout study ]
- 6 months incidence of adverse events [ Time Frame: At 6 months after kidney donation ]
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, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Donated kidney at one of the three participating study centers
Exclusion Criteria:
- None
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): NCT00608283
| 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 | |
| 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 |
Study Data/Documents: Individual Participant Data Set
ImmPort study identifier is SDY289
Publications of Results:
Other Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00608283 |
| Other Study ID Numbers: |
DAIT RELIVE-01 |
| First Posted: | February 6, 2008 Key Record Dates |
| Last Update Posted: | March 27, 2017 |
| Last Verified: | March 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts. |
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Kidney transplant Live donor transplant |
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Kidney Failure, Chronic Kidney Diseases Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency |