Kidney Donor Outcomes Cohort (KDOC) Study (KDOC)
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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
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Condition or disease |
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Living Donor Nephrectomy |

Study Type : | Observational |
Estimated Enrollment : | 720 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 |

Group/Cohort |
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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.
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- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
A total of 280 living kidney donors, 280 LDKT recipients, and 160 healthy comparison subjects meeting all eligibility criteria will be enrolled.
We will enroll both English and Spanish speaking participants into the study. All questionnaire outcomes will be translated into Spanish using conventional translational procedures and we will ensure that an interviewer at BIDMC is fluent in Spanish. It is important to emphasize that not all of the questionnaires used in this study have been validated in Spanish or with Hispanic patients. While this is an important limitation, we feel that this limitation is outweighed by the potential benefits of including primarily Spanish-speaking participants in the study.
Inclusion Criteria:
- 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)
Exclusion Criteria:
- inability or unwillingness to provide informed consent
- inability to speak and read English or Spanish

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 Clinic | |
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | James Rodrigue, Professor, Beth Israel Deaconess Medical Center |
ClinicalTrials.gov Identifier: | NCT01427452 |
Other Study ID Numbers: |
2010P000286 R01DK085185 ( U.S. NIH Grant/Contract ) |
First Posted: | September 1, 2011 Key Record Dates |
Last Update Posted: | March 20, 2018 |
Last Verified: | March 2018 |
Live Donor Kidney Donation Living Donation Live Donor Kidney Transplantation Donor Nephrectomy |