Live Kidney Donor Study -Renal Function Study

Kidney Transplantation Clinical Trial

Official title:

Live Kidney Donor Study -Renal Function Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01158742
• Other study ID #: DAIT RELIVE-06
• Status: Completed
• Phase: N/A
• First received: July 7, 2010
• Last updated: March 23, 2017
• Start date: September 2009
• Est. completion date: June 2012

Study information

• Verified date: March 2017
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Donation
• Kidney Failure
• Kidney Transplantation
• Renal Insufficiency

Intervention

Other:
• Glomerular Filtration Rate with Iothalamate
used to determine kidney function
• Glomerular Filtration Rate with Iohexol
used to determine kidney function

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Minnesota	Minneapolis	Minnesota
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Health Resources and Services Administration (HRSA), National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. A — View 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. C — View 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 — View 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 — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in measured GFR from before donor nephrectomy compared to early (within first 2 years) after donor nephrectomy.		Throughout study
Primary	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
Primary	Differences in measured GFR in black donors compared to white donors matched by age, sex and time from donation		Throughout study
Primary	Incremental differences between measured GFR and estimated GFR before donor nephrectomy, early after donor nephrectomy, and late after donor nephrectomy		Throughout study
Secondary	Differences in measured GFR between hypertensive donors and normotensive donors		Throughout study
Secondary	Differences in measured GFR between donors with familial history of renal disease (LRD) and donors without familial history of renal disease (LURD)		Throughout study

External Links

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