Live Kidney Donor Study

End Stage Renal Disease Clinical Trial

Official title:

Live Kidney Donor Study (RELIVE-01)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00608283
• Other study ID #: DAIT RELIVE-01
• Status: Completed
• Phase: N/A
• First received: February 5, 2008
• Last updated: March 23, 2017
• Start date: August 2007
• Est. completion date: June 2011

Study information

• Verified date: March 2017
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8951
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Donated kidney at one of the three participating study centers

Exclusion Criteria:

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic
• Kidney Transplantation

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Minnesota	Minneapolis	Minnesota
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Health Resources and Services Administration (HRSA), National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (9)

Baid-Agrawal S, Frei UA. Living donor renal transplantation: recent developments and perspectives. Nat Clin Pract Nephrol. 2007 Jan;3(1):31-41. Review. — View Citation

Fehrman-Ekholm I, Nordén G, Lennerling A, Rizell M, Mjörnstedt L, Wramner L, Olausson M. Incidence of end-stage renal disease among live kidney donors. Transplantation. 2006 Dec 27;82(12):1646-8. — View Citation

Gross CR, Messersmith EE, Hong BA, Jowsey SG, Jacobs C, Gillespie BW, Taler SJ, Matas AJ, Leichtman A, Merion RM, Ibrahim HN; RELIVE Study Group.. Health-related quality of life in kidney donors from the last five decades: results from the RELIVE study. A — View Citation

Jacobs CL, Gross CR, Messersmith EE, Hong BA, Gillespie BW, Hill-Callahan P, Taler SJ, Jowsey SG, Beebe TJ, Matas AJ, Odim J, Ibrahim HN; RELIVE Study Group.. Emotional and Financial Experiences of Kidney Donors over the Past 50 Years: The RELIVE Study. C — View Citation

Jowsey SG, Jacobs C, Gross CR, Hong BA, Messersmith EE, Gillespie BW, Beebe TJ, Kew C, Matas A, Yusen RD, Hill-Callahan M, Odim J, Taler SJ; RELIVE Study Group.. Emotional well-being of living kidney donors: findings from the RELIVE Study. Am J Transplant — View Citation

Messersmith EE, Gross CR, Beil CA, Gillespie BW, Jacobs C, Taler SJ, Merion RM, Jowsey SG, Leichtman AB, Hong BA; RELIVE Study Group.. Satisfaction With Life Among Living Kidney Donors: A RELIVE Study of Long-Term Donor Outcomes. Transplantation. 2014 Dec — View Citation

Noppakun K, Cosio FG, Dean PG, Taler SJ, Wauters R, Grande JP. Living donor age and kidney transplant outcomes. Am J Transplant. 2011 Jun;11(6):1279-86. doi: 10.1111/j.1600-6143.2011.03552.x. — View Citation

Øien CM, Reisaeter AV, Leivestad T, Dekker FW, Line PD, Os I. Living donor kidney transplantation: the effects of donor age and gender on short- and long-term outcomes. Transplantation. 2007 Mar 15;83(5):600-6. — View Citation

Taler SJ, Messersmith EE, Leichtman AB, Gillespie BW, Kew CE, Stegall MD, Merion RM, Matas AJ, Ibrahim HN; RELIVE Study Group.. Demographic, metabolic, and blood pressure characteristics of living kidney donors spanning five decades. Am J Transplant. 2013 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall mortality		Throughout study
Primary	Cause-specific mortality		Throughout study
Primary	End stage renal disease as defined in the protocol		Throughout study
Secondary	Cardiovascular and renal morbidity		Throughout study
Secondary	6 months incidence of adverse events		At 6 months after kidney donation

External Links

•   Division of Allergy, Immunology, and Transplantation (DAIT)
•   Health Resources and Services Administration (HRSA)
•   National Heart, Lung, and Blood Institute (NHLBI)
•   National Institute of Allergy and Infectious Diseases (NIAID)