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

NCT01564966 | Completed DMC

• 2 other identifiers: 201202094369
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.

Conditions

Kidney Failure; Hypertension; Albuminuria; Renal Failure; Inflammation; Endothelial Dysfunction

Keywords

transplantation; inflammation; endothelial dysfunction

Study Arms (1)

Living kidney donors

Those who donate kidneys

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Living kidney donors in Istanbul Faculty of Medicine

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal Insufficiency; Hypertension; Albuminuria; Inflammation

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Proteinuria; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Alaattin Yildiz, Professor of Medicine, MD

  Istanbul University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist of Nephrology, MD

Study Record Dates

• First Submitted: March 25, 2012
• First Posted: March 28, 2012
• Study Start: April 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 29, 2012

Record last verified: 2012-03

Locations

TU (1)