This study is led by principal investigator Macey L. Levan, JD, PhD, a faculty member in the Departments of Surgery and Population Health, and lead co-investigators Dorry L. Segev, MD, PhD, and Allan B. Massie, PhD. This study is conducted in collaboration with the Scientific Registry of Transplant Recipients (SRTR) under the leadership of Jon Snyder, PhD. SRTR provides advanced statistical and epidemiological analyses related to solid organ allocation and transplantation in support of the U.S. Department of Health and Human Services and its agents in their oversight of the national organ transplantation system. The purpose of this study is to learn about the long-term risk of kidney failure after kidney donation.

This study will also measure the prevalence of genetic mutations among living donors. The information from this study will help us to better understand the impact of genetic testing in order to improve counseling and evaluation for potential living donors.

We are actively recruiting participants to take part in this study. Your participation is voluntary, which means you can choose whether or not you want to take part.

Information About Gene Mutations Related to Kidney Health

A positive genetic test result means that a person does have a genetic variant present, but it does not mean that the person will develop kidney disease and kidney failure. A negative test result means that a person does not have the gene variant, but that does not mean they are less likely to develop kidney disease and kidney failure. There are several other factors that contribute to developing kidney disease, including health-related problems and family history of kidney disease.

You will have the opportunity to talk to a genetic counselor to learn more about genetic testing before deciding to participate in this study.

Key Information About the Study

This study will last about two years. Approximately 100 study subjects ages 18 and older are to be enrolled in this study. Some participants will be selected to participate in remote interviews, in which about 20 to 30 study subjects ages 18 or older will be enrolled.

In this study, you will be asked to complete a survey, genetic testing, and genetic counseling. Participants who are selected to participate in the remote interviews will be asked to complete one pre-genetic testing interview and one post-genetic testing interview.

Your participation in this study will last for approximately one and a half hours. The survey will take 15 to 30 minutes to complete. If you are asked to participate in the remote interviews, your participation will last up to an additional one hour. Each interview will take 15 to 30 minutes. We will schedule interviews at a time that is convenient for you.

Information About Natera

Natera is a genetic testing company that conducts noninvasive genetic testing. Natera offers the Renasight panel, which is focused on kidney health. If you choose to participate in this study, Natera will mail you a kit for at-home saliva genetic testing.

Information About Genome Medical

Genome Medical’s national network of genetic experts includes both medical geneticists and genetic counselors. Your consultation will most likely be with a genetic counselor who is a medical provider specially trained to understand the complexities of genetic tests and how to interpret your unique results. In certain cases, you may also work with a medical geneticist, a physician trained in general medicine, genetic diagnosis, and the treatment of patients with genetic disorders.

You will receive a clinical action plan that is provided to you once results are complete. The plan is a written summary of the results and guidance on any actionable insights.

Foreseeable Risk and Benefits

A comprehensive list of all possible risks and discomforts related to this research is included in the full consent form. The most common risks experienced include frustration or anxiety associated with completing the surveys or interviews and being recorded as well as stress, anxiety, and/or confusion related to genetic testing results.

You may or may not benefit personally from being in this study. You might feel that knowing your genetic testing results provides useful information to you or to your family members. We hope that others may benefit from what is learned by doing this study.

Alternatives to Participation

You may choose not to participate in this research study.

Next Steps for Interested Participants

For in-depth details regarding this study, please refer to the full informed consent form.

We will have both an opt-in and opt-out process. You can respond by phone to let us know whether or not you are interested in participating. Please contact our study to let us know if you are interested in participating in the study. You can reach our study team by calling 646-754-7404 or emailing kidneydonorresearch@nyulangone.org between 9:00AM and 5:00PM ET on Monday through Friday. You can also call this number if you do not want to be contacted about this study in the future.