findmyKOL
Clinical trialNCT01427452CompletedObservational

Kidney Donor Outcomes Cohort (KDOC) Study

SponsorBeth Israel Deaconess Medical CenterEnrollment720Living Donor Nephrectomy
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

7 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • 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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Aug 2011
Primary completion
28 Feb 2018
Completion
28 Feb 2018
Last update posted
20 Mar 2018
Registered enrollment
720
Registry id
NCT01427452

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.