Acute Renal FailureNCT00358306
The Role of Endothelium Dysfunction in Progression of CKD (Chronic Kidney Disease) After AKI (Acute Kidney Injury)
An observational study of Acute Renal Failure and Chronic Kidney Failure, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Renal Failure, Chronic Kidney Failure, Endothelial Dysfunction
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children 2-20 years old with history of acute kidney injury
Who may be able to join
- Children between age 2-20
- Decrease in renal function by 25% or greater
- Renal function has returned to normal
Who cannot join
- History of chronic disease
- Cancer
- Congenital heart disease
- Organ Transplantation
- Liver disease
- Pulmonary disease
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Acute Renal Failure, Chronic Kidney Failure, Endothelial Dysfunction, Hemolytic-uremic Syndrome (HUS)
- Keywords
- Endothelium, Chronic Kidney Disease, Acute Kidney Injury, Hemolytic-uremic syndrome (HUS)
- Medical subject headings
- Acute Kidney Injury, Kidney Failure, Chronic, Hemolytic-Uremic Syndrome, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| a | those with previous history of Acute kidney injury |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2006 (estimated)
- Study startApr 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Renal FailureStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Askenazi, University of Alabama at Birmingham
- Investigators
- David Askenazi, MD, Principal investigator, UAB Pediatric Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00358306
- Sponsor's protocol ID
- F070309010
- Status last verified
- May 2020
- First submitted
- 28 Jul 2006
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Endothelium Dysfunction in Progression of CKD (Chronic Kidney Disease) After AKI (Acute Kidney Injury)
- ClinicalTrials.gov ID
- NCT00358306
- Acronym / sponsor ID
- F070309010
- Conditions
- Acute Renal Failure, Chronic Kidney Failure, Endothelial Dysfunction, Hemolytic-uremic Syndrome (HUS)
- Keywords
- Endothelium, Chronic Kidney Disease, Acute Kidney Injury, Hemolytic-uremic syndrome (HUS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 31 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| a | – | –those with previous history of Acute kidney injury |
Who may qualify
- Ages
- 2 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children 2-20 years old with history of acute kidney injury
Key inclusion criteria (3 listed)
- Children between age 2-20
- Decrease in renal function by 25% or greater
- Renal function has returned to normal
Key exclusion criteria (14 listed)
- History of chronic disease
- Cancer
- Congenital heart disease
- Organ Transplantation
- Liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
Related trials for Acute Renal Failure
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Askenazi, MD principal investigator
UAB Pediatric Nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Renal Failure and Chronic Kidney Failure, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2020.