Pilot Prospective Study: Long-term Health of Living Kidney Donors

NCT ID: NCT00319579

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 330 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2009-08-31

Brief Summary

Kidney transplantation, a 'miracle' of modern medicine, is the preferred treatment option for End Stage Renal Disease compared to dialysis, patients who receive kidneys have a 70% reduction in risk of death, a dramatically improved quality of life and cost the health care system considerably less. As a result there are over 3000 Canadians, and 57,000 Americans on the waiting list for a kidney. To meet the shortage in cadaveric kidneys, rates of living kidney donation have nearly doubled over the last 10 years, and will continue to rise with growing demand.

Yet despite its advantages for the recipient, living kidney donation remains a complex ethical, moral and medical issue. The premise for accepting living donors is that the "minimal" risk of short and long-term medical harm realized by the donor is outweighed by the definite advantages to the recipient and potential psychosocial benefits of the altruistic gift to the donor. The only benefit for the living donor is psychological - donors experience increased self-esteem, feelings of well-being and improved health related quality of life with their altruistic act of assuming medical risk to help another. The short-term consequences of living donation are well established. On the other hand the long-term implications of living kidney donation are far less certain. This study will look at the long term implications of living kidney donation.

Conditions

Living Kidney Donors

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Observation

Living Kidney Donors with controls who have not donated a kidney and meet certain criteria at the time of the donor's donation (i.e. no hypertension, no kidney disease, etc.).

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Age greater than 18 years old

2. A predicted Cockcroft-Gault creatinine clearance > 80 mL/min

3. Average sBP < 140 and dBP < 90 based on 3 readings

4. A spot urine protein to creatinine ratio < 15 mg/mmol

Exclusion Criteria

1. A medical condition (such as cardiovascular disease, pulmonary disease, active cancer) or psychological condition (such as major affective disorder, personality disorder, a history of chemical dependence) which the local transplant centre deems unfit for donation. Blood group and immunological incompatibility (such as positive cross-match, poor HLA matches) are not reasons for exclusion

2. Evidence of a financial incentive for donation

3. A contraindication to general anaesthesia or surgery

4. A past medical history of hypertension

5. Use of antihypertensive class medications for any reason.(ACE-Is, ARBs, diuretics, beta-blockers, calcium channel blockers)

6. A past history of permanent proteinuria

7. The eligible non-donor is planning to donate their kidney within the next year

8. Unable to give informed consent

9. Unwilling to participate in the follow-up assessments at one, two, three, four and five years, or unwilling or unable to conduct home blood pressure or laboratory measurements

10. The living donor or eligible non-donor is currently pregnant

11. Despite being planned the donor nephrectomy does not take place

12. Enrolled in another clinical study which interferes with the conduct or outcomes of this study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Amit Garg

OTHER

Sponsor Role: lead

Responsible Party

Amit Garg

MD, MA, FRCPC, FACP, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Amit X Garg, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Locations

University of Colorado Health Sciences Center

Denver, Colorado, United States

Yale University and VAMC

West Haven, Connecticut, United States

Wayne State University

Detroit, Michigan, United States

Cleveland Clinic

Cleveland, Ohio, United States

Hume-Lee Transplant Center Renal/Pancreas Transplant Program

Richmond, Virginia, United States

MonashMedical Centre

Clayton, Victoria, Australia

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

University of Alberta

Edmonton, Alberta, Canada

St. Paul's Hospital

Vancouver, British Columbia, Canada

University of Manitoba

Winnipeg, Manitoba, Canada

Dalhousie University

Halifax, Nova Scotia, Canada

St. Joseph Hospital

Hamilton, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Countries

United States; Australia; Canada

References

Garcia-Ochoa C, Feldman LS, Nguan C, Monroy-Caudros M, Arnold JB, Barnieh L, Boudville N, Cuerden MS, Dipchand C, Gill JS, Karpinski M, Klarenbach S, Knoll G, Lok CE, Miller M, Prasad GVR, Sontrop JM, Storsley L, Garg AX. Impact of Perioperative Complications on Living Kidney Donor Health-Related Quality of Life and Mental Health: Results From a Prospective Cohort Study. Can J Kidney Health Dis. 2021 Aug 11;8:20543581211037429. doi: 10.1177/20543581211037429. eCollection 2021.

Reference Type: DERIVED

PMID: 34394947 (View on PubMed)

Garcia-Ochoa C, Feldman LS, Nguan C, Monroy-Cuadros M, Arnold J, Boudville N, Cuerden M, Dipchand C, Eng M, Gill J, Gourlay W, Karpinski M, Klarenbach S, Knoll G, Lentine KL, Lok CE, Luke P, Prasad GVR, Sener A, Sontrop JM, Storsley L, Treleaven D, Garg AX; Donor Nephrectomy Outcomes Research (DONOR) Network. Perioperative Complications During Living Donor Nephrectomy: Results From a Multicenter Cohort Study. Can J Kidney Health Dis. 2019 Jul 18;6:2054358119857718. doi: 10.1177/2054358119857718. eCollection 2019.

Reference Type: DERIVED

PMID: 31367455 (View on PubMed)

Other Identifiers

LKD Prospective Study

Identifier Type: -

Identifier Source: secondary_id

R-04-204

Identifier Type: -

Identifier Source: org_study_id