Live Kidney Donor Study -Renal Function Study

This study has been completed.
Sponsor:
Collaborators:
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01158742
First received: July 7, 2010
Last updated: September 13, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Kidney Donation
Kidney Failure
Kidney Transplantation
Other: Glomerular Filtration Rate with Iothalamate
Other: Glomerular Filtration Rate with Iohexol

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Live Kidney Donor Study -Renal Function Study

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Change in measured GFR from before donor nephrectomy compared to early (within first 2 years) after donor nephrectomy. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Differences in measured GFR in black donors compared to white donors matched by age, sex and time from donation [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Incremental differences between measured GFR and estimated GFR before donor nephrectomy, early after donor nephrectomy, and late after donor nephrectomy [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Differences in measured GFR between hypertensive donors and normotensive donors [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Differences in measured GFR between donors with familial history of renal disease (LRD) and donors without familial history of renal disease (LURD) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 402
Study Start Date: September 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Caucasians who donated a kidney at Mayo Clinic in Rochester, MN
Other: Glomerular Filtration Rate with Iothalamate
used to determine kidney function
Other Name: GFR
2
Caucasians who donated a kidney at the University of Minnesota
Other: Glomerular Filtration Rate with Iohexol
used to determine kidney function
Other Name: GFR
3
African-Americans who donated a kidney at the University of Alabama
Other: Glomerular Filtration Rate with Iothalamate
used to determine kidney function
Other Name: GFR

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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 participlants only)
  • Negative serum pregnancy test (Total Beta 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01158742

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Health Resources and Services Administration (HRSA)
Investigators
Principal Investigator: Sandra J. Taler, MD Mayo Clinic Rochester, MN
  More Information

No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01158742     History of Changes
Other Study ID Numbers: DAIT RELIVE-06
Study First Received: July 7, 2010
Last Updated: September 13, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Glomerular Filtration Rate

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 23, 2014