Live Kidney Donor Study - Cross-Sectional and Historical Cohort Study

[debbie]

Hi all,
I am curious as to your thoughts & opinions about getting involved with any study such as this one that I copied. 
Thanks for your input,
Debbie

Live Kidney Donor Study - Cross-Sectional and Historical Cohort Study
Questions to Consider Before Participating
Learn More
NCT ID:

NCT00951977
Trial status:

Open for Enrollment
Why is this study being done?

Living donor transplants provide several advantages over deceased donor kidneys, including a shorter waiting time. Living donor grafts also appear to have a lower rate of delayed graft function and improved long-term recipient and graft survival. Most published studies of living kidney donation have supported that the donation process is relatively safe for the donor. However, these reports also emphasize concerns that comprehensive long-term data on U.S. live donor outcomes are insufficient. One concern is that current data may underestimate the true long-term morbidity and mortality of living kidney donation. Additionally, older studies might not apply to the current donor population that includes older and more obese individuals.

This is an observational study to look at the long term outcomes in living kidney donors. This study also seeks to find out if living kidney donors are at higher risk for certain conditions when compared to people of similar backgrounds who have not donated a kidney. Medical history, completed questionnaires, and blood and urine tests will be collected from donors and non donors. The compiled data from donors and non donors will be compared. Risks for diseases related to the kidney, heart, and blood vessels will be examined between the two groups. Quality of life and health insurance status will also be compared.

The study will be conducted in 2 phases. All donors who donated a kidney between 5 and 50 years ago at one of the three study transplant centers will be asked to take part in Phase 1. Phase 1 aims to collect limited medical information using a short questionnaire. Phase 2 will include Phase 1 donors who agree to further assessments and matched community control participants. Participants in Phase 2 will be asked to complete more in-depth questionnaires on health status and quality of life. Phase 2 also involves height, weight, and blood pressure measurements. Blood and urine will be collected for this study if the participant does not have the necessary tests within 3 years of study participation.

Seven thousand-eight hundred-sixty four (7864) previous kidney donors and about two thousand-five hundred (2500) control subjects will be asked to take part in this study. Participants will be recruited for this study over a 2.5.

Who is eligible to participate?

Inclusion Criteria:

- Underwent a unilateral donor nephrectomy between 5 and 50 years ago; but no later than June 30, 2005

- Alive at the time of study recruitment

Exclusion Criteria:

- Inability to contact donor

Community Control Inclusion Criteria:

- Matched to donor as healthy subject with a medical encounter date within 5 years of the date of donation and alive at the time of study recruitment

- Same gender as donor

- Same race as donor

- Matched by age, not to differ by more than 2 years

- Matched by BMI, not to differ by more than 5 kg/m^2 (JHS only)

Community Control Exclusion Criteria:

- Inability to contact control participant

- Inability or unwillingness to provide informed consent

- Hypertension or identified Charlson comorbidity index variable diagnosed prior to or on the encounter date matched to the donor date of donation (REP only)

Who can I contact for additional information?

Rochester: Susanne Capelle - 507-266-8147


Where is the trial located?

    * Rochester, MN

Last updated: 09/15/2010

[sherri]

Debbie,

the study sounds very interesting and hopefully will add to research on living donor outcomes. It appears that only questionnaires, blood tests, urine are necessary and no invasive testing so that is also a plus. Considering the complications you have shared with us, you might be a great candidate for researchers to study.

I have participated in several studies related to living donation, most involving answering questions with some of my medical labs submitted as well. I do not qualiy for this study, as I donated in 2007, but it sounds like one I would like to participate in. Is there a down side or anything that makes you uncomfortable about participation?

Sherri

[Clark]

Thanks, Debbie! Which three transplant centers are they recruiting from? I, too, have participated in a couple of studies, and welcome the opportunity whenever it's presented. If you consent, I hope you have a good experience.

[Fr Pat]

     Looks to me like an excellent way of collecting solid data. I hope many will participate.
          Fr. Pat

[debbie]

Hi all,

I don't have much to say yet about this study except that I am getting involved...I will be involved with this one that I posted above and an additional one (don't remember what it is called, but will let you know when I receive the forms from the research team at the Fairview Minnesota facility - and, let you know which facilities are involved with this particular research)....Actually, the University of Minnesota - now Fairview - had been trying to find me for several years as that was the facility where the transplant occured....My name changed back to my maiden name after my divorce in addition to my address and I never notified the facility of those changes.....

Debbie

[Michael]

This study has been underway for more than a year although I haven't heard much of anything about it. Here are the details: http://clinicaltrials.gov/show/NCT00951977

The three participating transplant centers are University of Alabama - Birmingham (not yet recruiting), the Mayo Clinic, and University of Minnesota.