## Protocol Section
### Identification Module
**NCT ID:** NCT00319579

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

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

#### Organization Study ID Info
**ID:** R-04-204
#### Organization
**Class:** OTHER
**Full Name:** Lawson Health Research Institute
#### Secondary ID Infos
**ID:** LKD Prospective Study
### Status Module
#### Completion Date
**Date:** 2009-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-26

**Type:** ACTUAL

**Last Update Submit Date:** 2024-02-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-08

**Type:** ACTUAL

#### Start Date
**Date:** 2005-01

**Type:** ACTUAL

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2006-04-27
**Type:** ESTIMATED
**Study First Submit Date:** 2006-04-27
**Study First Submit QC Date:** 2006-04-27
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Canadian Institutes of Health Research (CIHR)

#### Lead Sponsor

**Class:** OTHER

**Name:** Amit Garg

#### Responsible Party

**Investigator Affiliation:** Lawson Health Research Institute

**Investigator Full Name:** Amit Garg

**Investigator Title:** MD, MA, FRCPC, FACP, PhD

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Living Kidney Donors

**Keywords:**

- living kidney donors

- prospective

- medical

- psychosocial

### Design Module

#### Bio Spec

**Description:** Serum and urine samples

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 330

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.).

**Label:** Observation

### Outcomes Module

#### Primary Outcomes

**Measure:** Hypertension in living kidney donors

**Time Frame:** Annually for 5 years post donation

### Eligibility Module

**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

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Living Kidney Donors

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Denver

**Country:** United States

**Facility:** University of Colorado Health Sciences Center

**State:** Colorado

**Zip:** 80262

**Location 2:**

**City:** West Haven

**Country:** United States

**Facility:** Yale University and VAMC

**State:** Connecticut

**Zip:** 06516

**Location 3:**

**City:** Detroit

**Country:** United States

**Facility:** Wayne State University

**State:** Michigan

**Zip:** 48201

**Location 4:**

**City:** Cleveland

**Country:** United States

**Facility:** Cleveland Clinic

**State:** Ohio

**Zip:** 44195

**Location 5:**

**City:** Richmond

**Country:** United States

**Facility:** Hume-Lee Transplant Center Renal/Pancreas Transplant Program

**State:** Virginia

**Zip:** 23298-0274

**Location 6:**

**City:** Clayton

**Country:** Australia

**Facility:** MonashMedical Centre

**State:** Victoria

**Zip:** 3168

**Location 7:**

**City:** Nedlands

**Country:** Australia

**Facility:** Sir Charles Gairdner Hospital

**State:** Western Australia

**Location 8:**

**City:** Edmonton

**Country:** Canada

**Facility:** University of Alberta

**State:** Alberta

**Zip:** T6G 2GS

**Location 9:**

**City:** Vancouver

**Country:** Canada

**Facility:** St. Paul's Hospital

**State:** British Columbia

**Zip:** V6Z 1Y6

**Location 10:**

**City:** Winnipeg

**Country:** Canada

**Facility:** University of Manitoba

**State:** Manitoba

**Zip:** R3A 1R9

**Location 11:**

**City:** Halifax

**Country:** Canada

**Facility:** Dalhousie University

**State:** Nova Scotia

**Zip:** B3H 1V8

**Location 12:**

**City:** Hamilton

**Country:** Canada

**Facility:** St. Joseph Hospital

**State:** Ontario

**Zip:** L8N 4A6

**Location 13:**

**City:** London

**Country:** Canada

**Facility:** London Health Sciences Centre

**State:** Ontario

**Zip:** N6C 6B5

**Location 14:**

**City:** Ottawa

**Country:** Canada

**Facility:** The Ottawa Hospital

**State:** Ontario

**Zip:** K1H 7W9

**Location 15:**

**City:** Toronto

**Country:** Canada

**Facility:** St. Michael's Hospital

**State:** Ontario

**Zip:** M5C 2T2

#### Overall Officials

**Official 1:**

**Affiliation:** Lawson Health Research Institute

**Name:** Amit X Garg, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** 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.

**PMID:** 34394947

**Citation:** 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.

**PMID:** 31367455

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
