Trial record 1 of 1 for:
NCT01427452
Kidney Donor Outcomes Cohort (KDOC) Study (KDOC)
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| ClinicalTrials.gov Identifier: NCT01427452 |
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Recruitment Status :
Completed
First Posted : September 1, 2011
Last Update Posted : March 20, 2018
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Sponsor:
Beth Israel Deaconess Medical Center
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
James Rodrigue, Beth Israel Deaconess Medical Center
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Brief 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 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.
| Condition or disease |
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| Living Donor Nephrectomy |
Show Detailed Description
| 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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Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
Information from the National Library of Medicine
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 |
Study Population
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.
Criteria
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
Information from the National Library of Medicine
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
Locations
| 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 | |
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
| Principal Investigator: | James R Rodrigue, Ph.D. | Beth Israel Deaconess Medical Center | |
| Principal Investigator: | Didier Mandelbrot, M.D. | Beth Israel Deaconess Medical Center |
Additional Information:
| Responsible Party: | James Rodrigue, Professor, Beth Israel Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT01427452 History of Changes |
| 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 |
Keywords provided by James Rodrigue, Beth Israel Deaconess Medical Center:
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Live Donor Kidney Donation Living Donation Live Donor Kidney Transplantation Donor Nephrectomy |