Live Kidney Donor Study -Renal Function Study

NCT ID: NCT01158742

Last Updated: 2017-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

402 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-06-30

Brief Summary

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Kidney transplantation from living donors has been shown to carry many benefits over deceased donor transplantation. Because of benefits such as shorter waiting times and improved outcome for transplant recipients, living kidney donation accounts for an increasing number of kidney transplants nationwide. Most published studies about living kidney donation demonstrate that the procedure is safe, but they also emphasize concerns that long-term data on live donor outcomes are insufficient. In particular, data concerning the extent of renal function decline after donation are inadequate. This study will measure glomerular filtration rate (GFR) in previous living donors and aims to more accurately describe renal function after kidney donation.

Detailed Description

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Previous studies poorly describe renal function after kidney donation. Most published studies of renal function after donation are based on predictive equations, which were not designed for living kidney donors. One concern is that use of these equations may underestimate glomerular filtration rate (GFR) following donation. Systematic underestimation of GFR may cause previous kidney donors to be inaccurately categorized as having chronic kidney disease (CKD).

While data for the entire kidney donor population are insufficient, there is even less available information about renal function after donation in black renal donors. In the general population, the incidence of end stage renal disease is higher among blacks compared to whites. Whether this pattern carries over to the black renal donor population is unclear.

The primary objectives of this study are to more accurately measure current GFR; evaluate the change in GFR before and after donation; compare measured GFR in donors matched by race, age, sex, time from donation, presence of hypertension, and presence of obesity; and evaluate differences between predictive equations and measured GFR.

This is an observational study to look at the long term outcomes in living kidney donors. Participants in this study will also be participants in DAIT RELIVE-04. As a part of this study, participants will have a brief medical history taken and a glomerular filtration rate test performed.

Conditions

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Kidney Donation Kidney Failure Kidney Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

Caucasians who donated a kidney at Mayo Clinic in Rochester, Minnesota (MN)

Glomerular Filtration Rate with Iothalamate

Intervention Type OTHER

used to determine kidney function

2

Caucasians who donated a kidney at the University of Minnesota

Glomerular Filtration Rate with Iohexol

Intervention Type OTHER

used to determine kidney function

3

African-Americans who donated a kidney at the University of Alabama

Glomerular Filtration Rate with Iothalamate

Intervention Type OTHER

used to determine kidney function

Interventions

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Glomerular Filtration Rate with Iothalamate

used to determine kidney function

Intervention Type OTHER

Glomerular Filtration Rate with Iohexol

used to determine kidney function

Intervention Type OTHER

Other Intervention Names

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GFR GFR

Eligibility Criteria

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Inclusion Criteria

* Underwent unilateral donor nephrectomy between 5 and 50 years ago; but no later than June 30, 2005 at Mayo Clinic or University of Minnesota
* Alive at the time of study recruitment
* Underwent GFR measurement before and early after donor nephrectomy (Mayo Clinic participants only)
* Underwent GFR measurement late after donor nephrectomy and 3 or more years prior to the invitation to participate in this study (UMN participants only)
* Self reported black race (UAB participants only)
* Negative serum pregnancy test (Total Beta Human Chorionic Gonadotropin (HCG) \<5) for women of child-bearing potential

Exclusion Criteria

* Less than 5 years out from time of kidney donation
* Inability to contact donor
* Inability or unwillingness to provide informed consent
* Iodine or iodinated contrast allergy.
* Pregnant or breast feeding women
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Health Resources and Services Administration (HRSA)

FED

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandra J. Taler, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic, Rochester, MN

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 23137211 (View on PubMed)

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.

Reference Type RESULT
PMID: 26463883 (View on PubMed)

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.

Reference Type RESULT
PMID: 25293374 (View on PubMed)

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.

Reference Type RESULT
PMID: 24011252 (View on PubMed)

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.

Reference Type RESULT
PMID: 21564530 (View on PubMed)

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.

Reference Type RESULT
PMID: 25136843 (View on PubMed)

Related Links

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https://www.niaid.nih.gov/

National Institute of Allergy and Infectious Diseases (NIAID) website

https://www.niaid.nih.gov/about/dait

Division of Allergy, Immunology, and Transplantation (DAIT) website

Other Identifiers

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DAIT RELIVE-06

Identifier Type: -

Identifier Source: org_study_id

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