Status:

COMPLETED

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

Lead Sponsor:

Amit Garg

Collaborating Sponsors:

Canadian Institutes of Health Research (CIHR)

Conditions:

Living Kidney Donors

Eligibility:

All Genders

18+ years

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...

Eligibility Criteria

Inclusion

  • Age greater than 18 years old
  • A predicted Cockcroft-Gault creatinine clearance \> 80 mL/min
  • Average sBP \< 140 and dBP \< 90 based on 3 readings
  • A spot urine protein to creatinine ratio \< 15 mg/mmol

Exclusion

  • 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
  • Evidence of a financial incentive for donation
  • A contraindication to general anaesthesia or surgery
  • A past medical history of hypertension
  • Use of antihypertensive class medications for any reason.(ACE-Is, ARBs, diuretics, beta-blockers, calcium channel blockers)
  • A past history of permanent proteinuria
  • The eligible non-donor is planning to donate their kidney within the next year
  • Unable to give informed consent
  • 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
  • The living donor or eligible non-donor is currently pregnant
  • Despite being planned the donor nephrectomy does not take place
  • Enrolled in another clinical study which interferes with the conduct or outcomes of this study

Key Trial Info

Start Date :

January 1 2005

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

August 1 2009

Estimated Enrollment :

330 Patients enrolled

Trial Details

Trial ID

NCT00319579

Start Date

January 1 2005

End Date

August 1 2009

Last Update

February 26 2024

Active Locations (15)

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Page 1 of 4 (15 locations)

1

University of Colorado Health Sciences Center

Denver, Colorado, United States, 80262

2

Yale University and VAMC

West Haven, Connecticut, United States, 06516

3

Wayne State University

Detroit, Michigan, United States, 48201

4

Cleveland Clinic

Cleveland, Ohio, United States, 44195