Live Kidney Donor Study -Renal Function Study

March 23, 2017 updated by: National Institute of Allergy and Infectious Diseases (NIAID)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

402

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • GFR
2
Caucasians who donated a kidney at the University of Minnesota
Other: Glomerular Filtration Rate with Iohexol
used to determine kidney function
Other Names:
  • 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 Names:
  • GFR

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Differences in measured GFR between hypertensive donors and normotensive donors
Time Frame: Throughout study
Throughout study
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
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Health Resources and Services Administration (HRSA)

Investigators

  • Principal Investigator: Sandra J. Taler, MD, Mayo Clinic, Rochester, MN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

July 7, 2010

First Submitted That Met QC Criteria

July 7, 2010

First Posted (ESTIMATE)

July 8, 2010

Study Record Updates

Last Update Posted (ACTUAL)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 23, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAIT RELIVE-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: SDY291
    Information comments: ImmPort study identifier is SDY291
  2. Study Protocol
    Information identifier: SDY291
    Information comments: ImmPort study identifier is SDY291. The study protocol is available through the Design tab on the site.
  3. Study summary, -design, -demographics, -files
    Information identifier: SDY291
    Information comments: ImmPort study identifier is SDY291

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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