Live Kidney Donor Study -Renal Function Study

NCT01158742 | Completed DMC

• 1 other identifier: DAIT RELIVE-06
• Study Type: observational
• Target: 402
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Kidney Donation; Kidney Failure; Kidney Transplantation

Keywords

Glomerular Filtration Rate

Outcome Measures

Primary Outcomes (4)

• Change in measured GFR from before donor nephrectomy compared to early (within first 2 years) after donor nephrectomy.

  Throughout study

• Change in measured GFR from early after donor nephrectomy compared to late donor nephrectomy. Change in measured GFR from early to late after donor nephrectomy stratified by: time since donation, hypertensive donors, obese donors, and age of donors

  Throughout study

• Differences in measured GFR in black donors compared to white donors matched by age, sex and time from donation

  Throughout study

• Incremental differences between measured GFR and estimated GFR before donor nephrectomy, early after donor nephrectomy, and late after donor nephrectomy

  Throughout study

Secondary Outcomes (2)

• Differences in measured GFR between hypertensive donors and normotensive donors

  Throughout study

• Differences in measured GFR between donors with familial history of renal disease (LRD) and donors without familial history of renal disease (LURD)

  Throughout study

Study Arms (3)

1

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

Other: Glomerular Filtration Rate with Iothalamate

2

Caucasians who donated a kidney at the University of Minnesota

Other: Glomerular Filtration Rate with Iohexol

3

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

Other: Glomerular Filtration Rate with Iothalamate

Interventions

Glomerular Filtration Rate with Iothalamate OTHER

used to determine kidney function

Also known as: GFR

1; 3

Glomerular Filtration Rate with Iohexol OTHER

used to determine kidney function

Also known as: GFR

2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

individuals participating in DAIT RELIVE-04 who donated a kidney at the Mayo Clinic-Rochester, University of Minnesota, or the University of Alabama

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Health Resources and Services Administration (HRSA): collaborator

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 (6)

• 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: 23137211 RESULT

• 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: 26463883 RESULT

• 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: 25293374 RESULT

• 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: 24011252 RESULT

• 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: 21564530 RESULT

• 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: 25136843 RESULT

Related Links

• National Institute of Allergy and Infectious Diseases (NIAID) website
• Division of Allergy, Immunology, and Transplantation (DAIT) website

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Glomerular Filtration Rate; Iothalamic Acid; Iohexol

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Kidney Function Tests; Diagnostic Techniques, Urological; Diagnostic Techniques and Procedures; Diagnosis; Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Sandra J. Taler, MD

  Mayo Clinic, Rochester, MN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2010
• First Posted: July 8, 2010
• Study Start: September 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 27, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

US (3)