Kidney Donor Outcomes Cohort (KDOC) Study

NCT01427452 | Completed

• 2 other identifiers: 2010P000286R01DK085185
• Study Type: observational
• Target: 720
• Locations: 1 country
• Sites: 7

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.

Conditions

Living Donor Nephrectomy

Keywords

Live Donor; Kidney Donation; Living Donation; Live Donor Kidney Transplantation; Donor Nephrectomy

Outcome Measures

Primary Outcomes (4)

• Surgical Outcomes

  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.

  1, 6, 12, and 24 Months Post-Surgery

• Medical Outcomes

  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.

  Baseline (pre-donation), 1, 6, 12, and 24 Months Post-Surgery

• Functional Outcomes

  Several functional outcomes will be measured, including: health-related quality of life, fatigue, physical activity, and return to work/school.

  Baseline, 1, 6, 12, and 24 Months Post-Surgery

• Psychological Outcomes

  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.

  Baseline, 1, 6, 12, and 24 Months Post-Surgery

Secondary Outcomes (1)

• Costs

  Baseline, 1, 6, 12, and 24 Months Post-Surgery

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• inability or unwillingness to provide informed consent
• inability to speak and read English or Spanish

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (7)

University of Arizona

Tucson, Arizona, United States

Location

University of Iowa

Iowa City, Iowa, United States

Location

Maine Medical Center

Portland, Maine, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Location

Montefiore Medical Center

The Bronx, New York, United States

Location

Cleveland Clinic

Cleveland, Ohio, United States

Location

Rhode Island Hospital

Providence, Rhode Island, United States

Location

Related Publications (1)

• Rodrigue JR, Fleishman A, Sokas CM, Schold JD, Morrissey P, Whiting J, Vella J, Kayler LK, Katz D, Jones J, Kaplan B, Pavlakis M, Mandelbrot DA. Rates of Living Kidney Donor Follow-up: Findings From the KDOC Study. Transplantation. 2019 Jul;103(7):e209-e210. doi: 10.1097/TP.0000000000002721. No abstract available.

  PMID: 31241558 DERIVED

Related Links

• Related Info

Study Officials

• James R Rodrigue, Ph.D.

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

• Didier Mandelbrot, M.D.

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 30, 2011
• First Posted: September 1, 2011
• Study Start: August 1, 2011
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: March 20, 2018

Record last verified: 2018-03

Locations

US (7)