Kidney Donor Outcomes Cohort (KDOC) Study
Completed
Conditions studied: Living Donor Nephrectomy
In brief
Live donor kidney transplantation (LDKT) is important because its outcomes for recipients are superior to those of deceased donor transplantation, and it yields significant cost savings to the healthcare system overall. Despite efforts over the past few decades to enhance understanding of the short- and long-term outcomes of living kidney donation, it is clear that investigators have more knowledge in some areas (e.g., surgical and medical complications) than in others (e.g., psychological outcomes, financial impact). While the transplant community and changes in federal regulations have brought attention to the need for more systematic study of living donor outcomes, there remains a paucity of scientifically rigorous multisite, prospective outcome studies. The long-term goal of this research program is to characterize the short- and long-term surgical, medical, functional, psychological, and financial outcomes of living kidney donation. The objective of this study is to establish a multisite prospective cohort of living kidney donors, their recipients, and a healthy comparison group. This cohort will be used to examine three primary aims: (1) to assess donor outcomes (surgical, medical, functional, psychological, financial) over a 2-year period initially, with the intention of examining these outcomes over a more extended time period in subsequent years; (2) to identify the donor, recipient, and center variables that are most predictive of donor outcomes; and (3) to identify disparities in donor outcomes and their predictors. To accomplish these aims, six kidney transplant programs, representing six states (Massachusetts, Maine, Rhode Island, New York, Iowa, and Arizona) and with experience and expertise in caring for living donors and transplant recipients, will participate in the study. Donors, their recipients, and healthy controls will complete comprehensive assessments at baseline (pre-surgery) and at 1, 6, 12, and 24 months post-donation. This study will extend the investigators considerable preliminary work by simultaneously examining outcomes that are of importance to donors, recipients, healthcare providers, and policymakers. The rationale for this research is that, once these outcomes and their predictors are known, investigators can further develop and refine educational strategies and informed consent processes for both living donors and their intended recipients, as well as provide systematic data to inform policy discussions and clinical care practice.
Key facts
- Study ID
- NCT01427452
- Run by
- Beth Israel Deaconess Medical Center
- People needed
- 720
- Starts
- 2011-08-01
- Expected to finish
- 2018-02-01
- Last updated by the study team
- 2018-03-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- at least 18 years old
- residential or cell phone service
- written informed consent
- medically cleared for donor nephrectomy (donor)
- medically cleared for transplant surgery (recipient)
- did not progress to donation, although medically eligible (control)
- completed preliminary labs (control)
You may not qualify if…
- inability or unwillingness to provide informed consent
- inability to speak and read English or Spanish
Where it is running
- University of Arizona — Tucson, Arizona, United States
- University of Iowa — Iowa City, Iowa, United States
- Maine Medical Center — Portland, Maine, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Montefiore Medical Center — The Bronx, New York, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- Rhode Island Hospital — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
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