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NCT01427452 · ClinicalTrials.gov registry record
Kidney Donor Outcomes Cohort (KDOC) Study
A clinical trial of Living Donor Nephrectomy, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- 720
- Enrollment target
- 7
- Study locations
NCT01427452: Completed study of Living Donor Nephrectomy, sponsored by Beth Israel Deaconess Medical Center.
NCT01427452 is a study of Living Donor Nephrectomy that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 720 participants. The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01427452, a study of Living Donor Nephrectomy, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- 720 participants
- Enrollment target
- 7
- Study locations
Study Summary
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 exte
Primary Outcome
Multiple surgical outcomes will be measured, including: operative time, surgical complications, re-operation, hospital length of stay, wound pain intensity, surgical scarring, and hospital readmissions.
Conditions Studied
Study Locations (7)
Arizona
- University of Arizona - Tucson
Iowa
- University of Iowa - Iowa City
Maine
- Maine Medical Center - Portland
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
New York
- Montefiore Medical Center - The Bronx
Ohio
- Cleveland Clinic - Cleveland
Rhode Island
- Rhode Island Hospital - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 720 participants |
| Start Date | 2011-08 |
| Est. Completion | 2018-02 |
What the finished NCT01427452 record still lists
NCT01427452 is an observational study that tracks outcomes without assigning an intervention. The registered 720 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Living Donor Nephrectomy appearing as the primary indexed condition, and to 0 interventions.
NCT01427452 lists 7 locations in 7 states (Arizona, Iowa, Maine).
Frequently Asked Questions
What is clinical trial NCT01427452 about?
NCT01427452 is a clinical study titled "Kidney Donor Outcomes Cohort (KDOC) Study". 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-...
What is the current status of trial NCT01427452?
This trial is currently completed. The enrollment target is 720 participants. The study started on 2011-08. Estimated completion is 2018-02.
What conditions does trial NCT01427452 study?
This clinical trial studies the following conditions: Living Donor Nephrectomy.
Who is sponsoring clinical trial NCT01427452?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01427452 being conducted?
This trial has 7 study locations across Arizona, Iowa, Maine, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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