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Living Kidney Donor Study (LKD)

This study is currently recruiting participants.
Verified August 2017 by Amit Garg, Lawson Health Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT00936078
First Posted: July 9, 2009
Last Update Posted: August 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Amit Garg, Lawson Health Research Institute
  Purpose
Living kidney donors and non-donor controls will be studied before and after the living donor transplant. The donor and non-donor will be followed for up to 5 years. The purpose of this study is to see if there are any differences between the two groups in regards to blood pressure, rate of hypertension, kidney function and psychological well being and economical status.

Condition
Living Kidney Donation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Effects of Becoming a Living Kidney Donor Study

Further study details as provided by Amit Garg, Lawson Health Research Institute:

Primary Outcome Measures:
  • Hypertension in kidney donors [ Time Frame: Annually for 5 years post donation ]

Biospecimen Retention:   Samples With DNA
Serum Urine

Estimated Enrollment: 600
Study Start Date: June 2009
Estimated Study Completion Date: December 31, 2021
Estimated Primary Completion Date: December 31, 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts
Non-donors/controls
People who have not donated a kidney.
Living Kidney Donors

Detailed Description:

Transplantation is the preferred treatment option for patients with kidney failure. Compared to dialysis, patients who receive a transplant have a substantial reduction in the risk of death, an improved quality of life, and decreased health care costs. The demand for kidneys has resulted in long waiting lists for deceased donor kidneys. Therefore, living kidney donations have been on the increase over the years in order to meet this demand for kidneys. Living donation also has the added benefit of a shorter waiting time, increased graft success and increased recipient survival compared to deceased donor transplantation.

Aside from the advantages for the recipient, living transplantation is a complex medical practice which we must conduct in a safe and ethical manner. 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 altruism to the donor. The short-term potential medical consequences for living kidney donors have been well established. Yet, the long-term implications of living kidney donation are far less certain. Potential medical risks include hypertension, proteinuria, reduced kidney function, premature cardiovascular disease and death. Estimates of these outcomes vary substantially in the literature. As well, the potential long-term medical risks are also communicated inconsistently across transplant community. It is accepted that most living donors experience increased self-esteem, feelings of well-being and an improved quality of life after their altruistic act. However, some donors have negative psychosocial outcomes which require further clarification. There is also a financial burden to the donor from the donation process. Concerns about future life, disability and medical insurance have been raised. These issues will be addressed through this research study on the long term implications of donation.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The donors will come from the identified population of people who will be donating their kidney at the hospital sites participating in this study.

The non-donor population will be people who the donors identify and ask to act as their control person. As well, controls will also be found using pamphlet and poster board advertising.

Criteria

Inclusion Criteria:

  • Be able to speak and read English and/or French, and
  • Be able to provide informed consent, and
  • Be between the ages of 18 - 70

AND

Subjects must either:

  • Be approved by the LHSC team (or applicable medical team at the participating sites) as eligible to donate their kidney,

OR

  • Meet study eligibility for controls (non-donors) as follows:
  • Meet blood pressure criteria as follows;
  • Blood pressure < 140 mmHg systolic and < 90 mmHg diastolic based on an average of last 3 blood pressure measurements taken during the interview, or Average blood pressure < 140 mmHg systolic and < 90 mmHg diastolic based on a minimum of 12 readings taken at home.
  • Meet local lab criteria as follows;
  • Documented pre-donation serum creatinine < 115µmol/L (1.3 mg/dL) in men or < 90µmol/L (1.0mg/dL) in women, or Cockcroft-Gault estimated glomerular filtration rate > 80 mL/min.
  • Urine dipstick test for protein is negative or a random urine albumin to creatinine ratio < 8 mg/mmol (70 mg/g)
  • Urine dipstick test for hematuria is negative. Test should not occur during menses, and test should be repeated if there is evidence of urinary tract infection.
  • Have a Body mass index of < 35 kg/m2

Exclusion Criteria:

  • Be involved in another clinical study that would affect the outcome of this study.

AND

  • Control (non-donors)subjects must not:
  • Ever have received dialysis, even for a short period of time
  • Ever have had a kidney transplant
  • Be taking any hypertension class medication for any reason
  • Have any history of hypertension, currently or in the past
  • Have plasma glucose of >7 mmol/L after a 6 hr fast, or a two hour oral glucose test of 11.1 mmol/L, or
  • Have a history of diabetes during pregnancy
  • Have been symptomatic for kidney stones any time in the past 3 years
  • Have a known contraindication to anesthesia or surgery, or
  • Be currently pregnant or have been pregnant in the past month, or
  • Have a medical condition that would prevent him or her from becoming a kidney donor (e.g. History of renal disease, Permanent protein in urine, Cancer other than cured non-melanoma skin cancer, Cardiovascular disease, Pulmonary disease)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00936078


Contacts
Contact: Jennifer Arnold, BA, BSc 519-685-8147 Jennifer.Arnold@lhsc.on.ca

Locations
Australia
Sir Charles Gairdner Hospital Recruiting
Perth, Australia
Contact: Neil Boudeville       neil.boudville@uwa.edu.au   
Principal Investigator: Neil Boudville, MD         
Canada, Alberta
Foothills Medical Centre Recruiting
Calgary, Alberta, Canada
Contact: Merline Watson    403-944-1953    Merline.Watson@albertahealthservices.ca   
Principal Investigator: Mauricio Monroy-Cuadros, MD         
University of Alberta Recruiting
Edmonton, Alberta, Canada
Contact: Lorena McCoshen    780-407-2797    mccoshen@ualberta.ca   
Principal Investigator: Scott Klarenbach         
Canada, British Columbia
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada
Contact: Angela Ogniben    604-682-2344 ext 64707    AOgniben@providencehealth.bc.ca   
Principal Investigator: John Gill, MD         
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada
Contact: Steven Tang    604-875-4111 ext 62337    steven.tang@ubc.ca   
Principal Investigator: Chris Nguan, MD         
Canada, Manitoba
Health Sciences Centre Recruiting
Winnipeg, Manitoba, Canada
Contact: Martin Karpinski       MKarpinski@exchange.hsc.mb.ca   
Principal Investigator: Martin Karpinski, MD         
Principal Investigator: Leroy Storsley, MD         
Canada, Nova Scotia
Queen Elizabeth II Hospital Recruiting
Halifax, Nova Scotia, Canada
Contact: Laura Sills    902-473-7625    Laura.Sills@cdha.nshealth.ca   
Principal Investigator: Christine Dipchand, MD         
Canada, Ontario
St. Joseph's Hospital Recruiting
Hamilton, Ontario, Canada
Contact: Faraz Lalji    (905) 522-1155 ext 33677    flalji@stjosham.on.ca   
Principal Investigator: Darin Treleaven, MD         
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Jennifer Arnold, BA, BSc    519-685-8147    Jennifer.Arnold@lhsc.on.ca   
Contact: Christina Frederiksen    519-685-8147    Christina.Frederiksen@lhsc.on.ca   
Principal Investigator: Amit Garg, MD, MA, FRCPC, FACP         
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada
Contact: Greg Knoll       GKNOLL@toh.ca   
Principal Investigator: Greg Knoll, MD         
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada
Contact: Lindita Rapi    416867-7460 ext 8024    Rapil@smh.toronto.on.ca   
Principal Investigator: Ramesh Prasad, MD         
University Health Network Recruiting
Toronto, Ontario, Canada
Contact: Eliot Winkler    416-340-4748    Eliot.Winkler@uhnresearch.ca   
Principal Investigator: Charmaine Lok, MD         
Canada, Quebec
The Montreal General Hospital Active, not recruiting
Montreal, Quebec, Canada
Sponsors and Collaborators
Lawson Health Research Institute
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Amit Garg, MD, MA, FRCPC, FACP London Health Sciences Centre
  More Information

Responsible Party: Amit Garg, Associate Professor, Medicine; Consultant Nephrology LHSC (as of July 1, 2003), Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00936078     History of Changes
Other Study ID Numbers: R-09-117
15974 ( Other Identifier: REB )
First Submitted: July 7, 2009
First Posted: July 9, 2009
Last Update Posted: August 23, 2017
Last Verified: August 2017

Keywords provided by Amit Garg, Lawson Health Research Institute:
kidney transplantation
cohort study
qualitative research
health services research
hypertension