Kidney Donor Outcomes Cohort (KDOC) Study (KDOC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01427452|
Recruitment Status : Completed
First Posted : September 1, 2011
Last Update Posted : March 20, 2018
|Condition or disease|
|Living Donor Nephrectomy|
|Study Type :||Observational|
|Estimated Enrollment :||720 participants|
|Official Title:||Kidney Donor Outcomes Cohort (KDOC) Study|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||February 2018|
|Actual Study Completion Date :||February 2018|
Living Kidney Donor, Transplant Recipient, Healthy Control
Living kidney donors and their transplant recipient will be enrolled. Also, a smaller cohort of healthy controls (potential donors who were medically suitable but not used) will be enrolled.
- Surgical Outcomes [ Time Frame: 1, 6, 12, and 24 Months Post-Surgery ]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.
- Medical Outcomes [ Time Frame: Baseline (pre-donation), 1, 6, 12, and 24 Months Post-Surgery ]Multiple medical outcomes will be measured, including: blood pressure, creatinine, body mass index, serum creatinine, 24 hr creatinine clearance, 24 hr protein, 24 hr albumin, fasting glucose, hemoglobin, total cholesterol, LDL, and HDL.
- Functional Outcomes [ Time Frame: Baseline, 1, 6, 12, and 24 Months Post-Surgery ]Several functional outcomes will be measured, including: health-related quality of life, fatigue, physical activity, and return to work/school.
- Psychological Outcomes [ Time Frame: Baseline, 1, 6, 12, and 24 Months Post-Surgery ]Multiple psychological outcomes will be measured, including: donation pressure/coercion, mood, body image, donation benefits, life satisfaction, fear of kidney failure, decision stability, and donor-recipient relationship.
- Costs [ Time Frame: Baseline, 1, 6, 12, and 24 Months Post-Surgery ]We are assessing the financial impact of living kidney donation by assessing both direct and indirect costs associated with donor evaluation, surgical recovery and rehabilitation, and long-term recovery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01427452
|United States, Arizona|
|University of Arizona|
|Tucson, Arizona, United States|
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States|
|United States, Maine|
|Maine Medical Center|
|Portland, Maine, United States|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States|
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States|
|United States, Ohio|
|Cleveland, Ohio, United States|
|United States, Rhode Island|
|Rhode Island Hospital|
|Providence, Rhode Island, United States|
|Principal Investigator:||James R Rodrigue, Ph.D.||Beth Israel Deaconess Medical Center|
|Principal Investigator:||Didier Mandelbrot, M.D.||Beth Israel Deaconess Medical Center|