Kidney Donor Outcomes Cohort (KDOC) Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
James Rodrigue, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01427452
First received: August 30, 2011
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

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
Living Donor Nephrectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Kidney Donor Outcomes Cohort (KDOC) Study

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Surgical Outcomes [ Time Frame: 1, 6, 12, and 24 Months Post-Surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 720
Study Start Date: August 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: James R Rodrigue, Ph.D. Beth Israel Deaconess Medical Center
Principal Investigator: Didier Mandelbrot, M.D. Beth Israel Deaconess Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: James Rodrigue, Associate Professor, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01427452     History of Changes
Other Study ID Numbers: 2010P-000286, R01DK085185
Study First Received: August 30, 2011
Last Updated: October 18, 2013
Health Authority: United States: Federal Government

Keywords provided by Beth Israel Deaconess Medical Center:
Live Donor
Kidney Donation
Living Donation
Live Donor Kidney Transplantation
Donor Nephrectomy

ClinicalTrials.gov processed this record on October 19, 2014