Live Kidney Donor Study

March 23, 2017 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Live Kidney Donor Study (RELIVE-01)

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

8951

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

  • Donated kidney at one of the three participating study centers

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Live Kidney Donors
People who are going to donate a kidney at one of the three transplant centers from August 2007 until June 2011

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall mortality
Time Frame: Throughout study
Throughout study
Cause-specific mortality
Time Frame: Throughout study
Throughout study
End stage renal disease as defined in the protocol
Time Frame: Throughout study
Throughout study

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular and renal morbidity
Time Frame: Throughout study
Throughout study
6 months incidence of adverse events
Time Frame: At 6 months after kidney donation
At 6 months after kidney donation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

February 5, 2008

First Submitted That Met QC Criteria

February 5, 2008

First Posted (Estimate)

February 6, 2008

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 23, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAIT RELIVE-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: SDY289
    Information comments: ImmPort study identifier is SDY289
  2. Study Protocol
    Information identifier: SDY289
    Information comments: ImmPort study identifier is SDY289
  3. Study summary, -design, -demographics, -files
    Information identifier: SDY289
    Information comments: ImmPort study identifier is SDY289

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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