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

Living Kidney Donors Clinical Trial

Official title:

The Long Term Medical and Psychological Implications of Becoming a Living Kidney Donor: A Prospective Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00319579
• Other study ID #: R-04-204
• Secondary ID: LKD Prospective
• Status: Completed
• Start date: January 2005
• Est. completion date: August 2009

Study information

• Verified date: February 2024
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Living Kidney Donors

Locations

Country	Name	City	State
Australia	MonashMedical Centre	Clayton	Victoria
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Canada	University of Alberta	Edmonton	Alberta
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	St. Paul's Hospital	Vancouver	British Columbia
Canada	University of Manitoba	Winnipeg	Manitoba
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Colorado Health Sciences Center	Denver	Colorado
United States	Wayne State University	Detroit	Michigan
United States	Hume-Lee Transplant Center Renal/Pancreas Transplant Program	Richmond	Virginia
United States	Yale University and VAMC	West Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Amit Garg	Canadian Institutes of Health Research (CIHR)

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypertension in living kidney donors		Annually for 5 years post donation