Cardiovascular-Renal Consequences of Reducing Renal Mass After Living Kidney Donation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yasar Caliskan, Istanbul University
ClinicalTrials.gov Identifier:
NCT01564966
First received: March 25, 2012
Last updated: March 28, 2012
Last verified: March 2012
  Purpose
  • A reduce in renal mass may result in remnant single nephron hyperfiltration, with associated proteinuria and an accelerated loss of kidney function.
  • Live-donor kidney transplantation is generally considered the best choice for patients who have renal failure and are awaiting transplantation, because these kidneys function better than kidneys from deceased donors, and waiting times for deceased-donor transplants are long
  • Although several studies have shown that kidney donation has low short-term morbidity and mortality, the data on long-term outcomes are much less complete.
  • This study is designed to prospectively evaluate the effects of unilateral nephrectomy on cardiovascular-renal functions of donors after living kidney donation: the development of hypertension, albuminuria, renal failure, inflammatory and endothelial changes.

Condition
Kidney Failure
Hypertension
Albuminuria
Renal Failure
Inflammation
Endothelial Dysfunction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiovascular-Renal Consequences of Reducing Renal Mass After Living Kidney Donation

Resource links provided by NLM:


Further study details as provided by Istanbul University:

Enrollment: 46
Study Start Date: April 2008
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Living kidney donors
Those who donate kidneys

Detailed Description:

Renal dysfunction is associated with accelerated cardiovascular disease even when kidney function is only mildly impaired. Besides, even levels of urinary albumin excretion below the accepted threshold for microalbuminuria are associated with increased cardiovascular risk, and the risk increases as the degree of proteinuria rises.

  • Live-donor kidney transplantation is generally considered the best choice for patients who have renal failure and are awaiting transplantation, because these kidneys function better than kidneys from deceased donors, and waiting times for deceased-donor transplants are long. Although several studies have shown that kidney donation has low short-term morbidity and mortality, the data on long-term outcomes are much less complete. The short and long term renal functions of donors after kidney donation were much studied and still remain uncertain, the cardiovascular effects of reduction in renal mass in kidney donors is also not clearly known.
  • Endothelial dysfunction (ED) is the first step for subsequent development of atherosclerosis, which can help us to assess the cardiovascular changes after kidney donation. Prospectively examining the endothelial consequences of uninephrectomy in donors may provide useful insight into the existence and pathophysiology of cardiovascular disease in donors and, therefore, into how the cardiovascular disease risk associated with renal impairment might eventually be reduced.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Living kidney donors in Istanbul Faculty of Medicine

Criteria

Inclusion Criteria:

  • living kidney donors
  • Ages of 18 and 70
  • Creatinine clearance at donation > 80 ml/min/1.73 m2

Exclusion Criteria:

  • Low (< 80 ml/min/1.73 m2) creatinine clearance at donation
  • Diabetes mellitus
  • Hypertension
  • Valvular heart disease, any prior coronary intervention
  • Congestive heart failure (New York Heart Association class II or greater)
  • Cardiac arrhythmia
  • A history of cerebral infarction or transient ischemic attack
  • Active infection or non-infectious overt inflammation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01564966

Locations
Turkey
Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University
Istanbul, Turkey, 34093
Sponsors and Collaborators
Istanbul University
Investigators
Study Director: Alaattin Yildiz, Professor of Medicine, MD Istanbul University, Istanbul Faculty of Medicine
  More Information

No publications provided

Responsible Party: Yasar Caliskan, Specialist of Nephrology, MD, Istanbul University
ClinicalTrials.gov Identifier: NCT01564966     History of Changes
Other Study ID Numbers: 20120209, 4369
Study First Received: March 25, 2012
Last Updated: March 28, 2012
Health Authority: Turkey: Ministry of Health

Keywords provided by Istanbul University:
transplantation
inflammation
endothelial dysfunction

Additional relevant MeSH terms:
Albuminuria
Hypertension
Inflammation
Renal Insufficiency
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Kidney Diseases

ClinicalTrials.gov processed this record on June 18, 2013