Cardiovascular-Renal Consequences of Reducing Renal Mass After Living Kidney Donation
This study has been completed.
Sponsor:
Istanbul University
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
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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