- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00358306
The Role of Endothelium Dysfunction in Progression of CKD (Chronic Kidney Disease) After AKI (Acute Kidney Injury)
May 12, 2020 updated by: David Askenazi, University of Alabama at Birmingham
To understand how AKI (Acute Kidney Injury) leads to chronic kidney disease so therapies can be found to alter the progression of events thereby significantly impacting the long-term outcomes of children who develop AKI.
Study Overview
Status
Completed
Detailed Description
This research study is designed to study what happens to the kidneys after they have an injury.
There is some evidence that even if there appears to be great improvement of kidney function, an injury can put patients at risk for long-term problems with their kidney function and increase their risk to have high blood pressure.
We want to collect information from participants to help explain why this injury can cause future problems, including Chronic Kidney Disease (CKD) which may help us prevent these health problems.
Study Type
Observational
Enrollment (Actual)
36
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35233
- University of Alabama
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children 2-20 years old with history of acute kidney injury
Description
Inclusion Criteria:
- Children between age 2-20
- Decrease in renal function by 25% or greater
- Renal function has returned to normal
Exclusion Criteria:
- History of chronic disease
- Cancer
- Congenital heart disease
- Organ Transplantation
- Liver disease
- Pulmonary disease
- Diabetes other primary metabolic condition
- Severe neurologic impairments
- Hypertension
- Auto-immune
- Infectious disease or renal disease
- Smokers
- Renal disease w/primary cause i.e. - HUS or Glomerulonephritis
- severe allergies including allergy to seafood and/or iodine
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
---|
a
those with previous history of Acute kidney injury
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: David Askenazi, MD, UAB Pediatric Nephrology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
July 28, 2006
First Submitted That Met QC Criteria
July 28, 2006
First Posted (Estimate)
July 31, 2006
Study Record Updates
Last Update Posted (Actual)
May 14, 2020
Last Update Submitted That Met QC Criteria
May 12, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Urologic Diseases
- Hematologic Diseases
- Anemia
- Thrombocytopenia
- Blood Platelet Disorders
- Anemia, Hemolytic
- Thrombotic Microangiopathies
- Uremia
- Kidney Diseases
- Renal Insufficiency, Chronic
- Kidney Failure, Chronic
- Renal Insufficiency
- Acute Kidney Injury
- Hemolysis
- Hemolytic-Uremic Syndrome
Other Study ID Numbers
- F070309010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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