NCT00608283

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,951

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2007

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

3.8 years

First QC Date

February 5, 2008

Last Update Submit

March 23, 2017

Conditions

Kidney TransplantationEnd Stage Renal Disease

Keywords

Kidney transplantLive donor transplant

Outcome Measures

Primary Outcomes (3)

  • Overall mortality

    Throughout study

  • Cause-specific mortality

    Throughout study

  • End stage renal disease as defined in the protocol

    Throughout study

Secondary Outcomes (2)

  • Cardiovascular and renal morbidity

    Throughout study

  • 6 months incidence of adverse events

    At 6 months after kidney donation

Study Arms (1)

Live Kidney Donors

People who are going to donate a kidney at one of the three transplant centers from August 2007 until June 2011

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Donated kidney at one of the three participating study centers

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related 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. doi: 10.1038/ncpneph0383.

    PMID: 17183260BACKGROUND

  • Fehrman-Ekholm I, Norden G, Lennerling A, Rizell M, Mjornstedt L, Wramner L, Olausson M. Incidence of end-stage renal disease among live kidney donors. Transplantation. 2006 Dec 27;82(12):1646-8. doi: 10.1097/01.tp.0000250728.73268.e3.

    PMID: 17198252BACKGROUND

  • Oien 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. doi: 10.1097/01.tp.0000255583.34329.dd.

    PMID: 17353781BACKGROUND

  • 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 Feb;13(2):390-8. doi: 10.1111/j.1600-6143.2012.04321.x. Epub 2012 Nov 8.

    PMID: 23137211RESULT

  • 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. Clin J Am Soc Nephrol. 2015 Dec 7;10(12):2221-31. doi: 10.2215/CJN.07120714. Epub 2015 Oct 13.

    PMID: 26463883RESULT

  • 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. 2014 Nov;14(11):2535-44. doi: 10.1111/ajt.12906. Epub 2014 Oct 7.

    PMID: 25293374RESULT

  • 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. Am J Transplant. 2013 Nov;13(11):2924-34. doi: 10.1111/ajt.12434. Epub 2013 Sep 6.

    PMID: 24011252RESULT

  • 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. Epub 2011 May 12.

    PMID: 21564530RESULT

  • 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 27;98(12):1294-300. doi: 10.1097/TP.0000000000000360.

    PMID: 25136843RESULT

Related Links

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2008

First Posted

February 6, 2008

Study Start

August 1, 2007

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

March 27, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

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.

Available IPD Datasets

Individual Participant Data Set (SDY289)Access
Study Protocol (SDY289)Access
Study summary, -design, -demographics, -files (SDY289)Access

Locations

US(3)