Kidney Donor Outcomes Cohort (KDOC) Study
Public ClinicalTrials.gov record NCT01427452. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01427452
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 720 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2011
- Primary completion
- Jan 31, 2018
- Completion
- Jan 31, 2018
- Last update posted
- Mar 19, 2018
2011 – 2018
United States locations
- U.S. sites
- 7
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | — | — |
| University of Iowa | Iowa City | Iowa | — | — |
| Maine Medical Center | Portland | Maine | — | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | — | — |
| Montefiore Medical Center | The Bronx | New York | — | — |
| Cleveland Clinic | Cleveland | Ohio | — | — |
| Rhode Island Hospital | Providence | Rhode Island | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01427452, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 19, 2018 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01427452 live on ClinicalTrials.gov.