Live Kidney Donor Study - Cross-Sectional and Historical Cohort Study

NCT00951977 | Completed DMC

• 1 other identifier: DAIT RELIVE-04
• Study Type: observational
• Target: 7,029
• 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. The purpose of this study is to assess the long term outcomes and risks that may arise from living kidney donation.

Conditions

End Stage Renal Disease; Transplantation

Keywords

End Stage Renal Disease (ESRD); Transplantation; Living Kidney Donation; Kidney Transplant

Outcome Measures

Primary Outcomes (3)

• Prevalence and incidence of hypertension, proteinuria, renal disease, and anemia

  Since donation

• Prevalence and incidence of cardiovascular disease as manifested by myocardial infarction (MI), heart failure (HF), stroke, and CABG/PTCA

  Since donation

• Quality of life and insurance status

  Since donation

Secondary Outcomes (10)

• Incidence of hypertension, proteinuria, renal disease, anemia, and QOL in black and white donors.

  Since donation

• Incidence of hypertension, proteinuria, renal disease, anemia, and QOL in donors with open nephrectomy and in donors with laparoscopic nephrectomy.

  Since donation

• The operative morbidity in living kidney donors with open nephrectomy and in donors with laparoscopic nephrectomy.

  Since donation

• Incidence of hypertension, proteinuria, renal disease, anemia, and QOL in standard living kidney donors and extended criteria donors.

  Since donation

• Incidence of hypertension, proteinuria, renal disease, anemia, and QOL in donors more than 20 years since donation and in donors between 5 and 20 years since donation.

  Since donation

Study Arms (2)

Subjects who have formerly donated a kidney

Matched community control Subjects

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who have either donated a kidney or control subjects who are matched to have similar demographics and health condition a donor in the study.

You may qualify if:

• Underwent a unilateral donor nephrectomy between 5 and 50 years ago; but no later than June 30, 2005
• Alive at the time of study recruitment

You may not qualify if:

• Inability to contact donor
• Matched to donor as healthy subject with a medical encounter date within 5 years of the date of donation and alive at the time of study recruitment
• Same gender as donor
• Same race as donor
• Matched by age, not to differ by more than 2 years
• Matched by BMI, not to differ by more than 5 kg/m\^2 (JHS only)
• Inability to contact control participant
• Inability or unwillingness to provide informed consent
• Hypertension or identified Charlson comorbidity index variable diagnosed prior to or on the encounter date matched to the donor date of donation (REP only)

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 (10)

• Bieniasz M, Domagala P, Kwiatkowski A, Gozdowska J, Krzysztof O, Kieszek RA, Trzebicki J, Durlik M, Rowinski W, Chmura A. The assessment of residual kidney function after living donor nephrectomy. Transplant Proc. 2009 Jan-Feb;41(1):91-2. doi: 10.1016/j.transproceed.2008.08.160.

  PMID: 19249485 BACKGROUND

• Hernandez D, Alvarez A, Armas A, Rufino M, Porrini E, Torres A. [Metabolic syndrome and live kidney donor: is this syndrome a contraindication to donation?]. Nefrologia. 2009;29(1):20-9. doi: 10.3265/Nefrologia.2009.29.1.20.1.en.full.pdf. Spanish.

  PMID: 19240768 BACKGROUND

• Horvat LD, Shariff SZ, Garg AX; Donor Nephrectomy Outcomes Research (DONOR) Network. Global trends in the rates of living kidney donation. Kidney Int. 2009 May;75(10):1088-98. doi: 10.1038/ki.2009.20. Epub 2009 Feb 18.

  PMID: 19225540 BACKGROUND

• Rowinski W, Chmura A, Wlodarczyk Z, Ostrowski M, Rutkowski B, Domagala P, Dziewanowski K, Matych J, Durlik M, Grenda R. Are we taking proper care of living donors? A follow-up study of living kidney donors in Poland and further management proposal. Transplant Proc. 2009 Jan-Feb;41(1):79-81. doi: 10.1016/j.transproceed.2008.08.140.

  PMID: 19249481 BACKGROUND

• 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
• National Heart, Lung, and Blood Institute website
• National Kidney Registry website

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sandra J. Taler, MD

  Mayo Clinic, Division of Nephrology and Hypertension

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 31, 2009
• First Posted: August 4, 2009
• Study Start: October 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 14, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

US (3)