Clinical trial NCT01158742: Live Kidney Donor Study -Renal Function Study
Official title: Live Kidney Donor Study -Renal Function Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Donation
Kidney Failure
Kidney Transplantation
Keywords: Glomerular Filtration Rate
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Health Resources and Services Administration (HRSA)
First posted: 2010-07-08
Enrollment: 402
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in measured GFR from before donor nephrectomy compared to early (within first 2 years) after donor nephrectomy.
timeFrame: Throughout study
measure: 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
timeFrame: Throughout study
measure: Differences in measured GFR in black donors compared to white donors matched by age, sex and time from donation
timeFrame: Throughout study
measure: Incremental differences between measured GFR and estimated GFR before donor nephrectomy, early after donor nephrectomy, and late after donor nephrectomy
timeFrame: Throughout study
Secondary outcomes:
measure: Differences in measured GFR between hypertensive donors and normotensive donors
timeFrame: Throughout study
measure: Differences in measured GFR between donors with familial history of renal disease (LRD) and donors without familial history of renal disease (LURD)
timeFrame: Throughout study
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic, Rochester, MN
name: Sandra J. Taler, MD
role: PRINCIPAL_INVESTIGATOR
References:
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 Feb;13(2):390-8. doi: 10.1111/j.1600-6143.2012.04321.x. Epub 2012 Nov 8.
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. Clin J Am Soc Nephrol. 2015 Dec 7;10(12):2221-31. doi: 10.2215/CJN.07120714. Epub 2015 Oct 13.
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. 2014 Nov;14(11):2535-44. doi: 10.1111/ajt.12906. Epub 2014 Oct 7.
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. Am J Transplant. 2013 Nov;13(11):2924-34. doi: 10.1111/ajt.12434. Epub 2013 Sep 6.
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. Epub 2011 May 12.
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 27;98(12):1294-300. doi: 10.1097/TP.0000000000000360.