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Live Kidney Donor Study -Renal Function Study

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ClinicalTrials.gov Identifier: NCT01158742
Recruitment Status : Completed
First Posted : July 8, 2010
Last Update Posted : March 27, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Kidney Donation Kidney Failure Kidney Transplantation Other: Glomerular Filtration Rate with Iothalamate Other: Glomerular Filtration Rate with Iohexol

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.


Study Design

Study Type : Observational
Actual Enrollment : 402 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Live Kidney Donor Study -Renal Function Study
Study Start Date : September 2009
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
1
Caucasians who donated a kidney at Mayo Clinic in Rochester, Minnesota (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


Outcome Measures

Primary Outcome Measures :
  1. Change in measured GFR from before donor nephrectomy compared to early (within first 2 years) after donor nephrectomy. [ Time Frame: Throughout study ]
  2. 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 ]
  3. Differences in measured GFR in black donors compared to white donors matched by age, sex and time from donation [ Time Frame: Throughout study ]
  4. Incremental differences between measured GFR and estimated GFR before donor nephrectomy, early after donor nephrectomy, and late after donor nephrectomy [ Time Frame: Throughout study ]

Secondary Outcome Measures :
  1. Differences in measured GFR between hypertensive donors and normotensive donors [ Time Frame: Throughout study ]
  2. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institute of Allergy and Infectious Diseases (NIAID)
National Heart, Lung, and Blood Institute (NHLBI)
Health Resources and Services Administration (HRSA)
Investigators
Principal Investigator: Sandra J. Taler, MD Mayo Clinic Rochester, MN
More Information

Additional Information:
Publications:

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: SDY291
ImmPort study identifier is SDY291
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: SDY291
ImmPort study identifier is SDY291. The study protocol is available through the Design tab on the site.
Study summary, -design, -demographics, -files  This link exits the ClinicalTrials.gov site
Identifier: SDY291
ImmPort study identifier is SDY291

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01158742     History of Changes
Other Study ID Numbers: DAIT RELIVE-06
First Posted: July 8, 2010    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.

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

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases