Kidney DiseaseNCT00026702
Search for New Methods to Detect Acute Renal Failure
An observational study of Kidney Disease and Kidney Failure, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
The purpose of this study is to find substances in the blood and urine that indicate that a person has kidney damage. It will identify proteins found only in patients with acute kidney failure but not in normal healthy people or in patients with volume depletion. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Disease, Kidney Failure, Kidney Failure, Chronic
- How many people
- 226 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2000to 12 Mar 2026
- 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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: subjects with and without kidney disease, can include vulnerable populations such as pregnant women, cognitively impaired adults, or NIH employees
Who may be able to join
- Subjects >= 3 years old. Both male and female subjects will be recruited without regard to race or ethnic origin.
- Either:
- Normal (creatinine level < 1.3 mg/dl for adults; creatinine level < standard nomogram for children), OR
- Oliguria due to volume depletion (indicated by oliguria and Fractional Excretion of Sodium (FENa) of less than 1%), OR
- High risk of ARF, including surgery, transplantation, nephrotoxic antibiotics, or bone marrow transplant. OR
- Evidence of ARF as defined by an acute progressive rise in serum creatinine (at least 50% increase within 24 hours preceding enrollment) without stabilization or recovery, despite optimization of hemodynamic fluid status and correction of any known pharmacologic, pre-renal, or post-renal etiologic factors. OR
- Urinary tract infection (to serve as control for ARF studies), OR
- Established chronic kidney disease (to serve as control for ARF studies).
Who cannot join
- Minors who do not give clear assent, even with parental consent
- Existence of any other condition which would complicate the implementation or interpretation of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Search for Novel Methods to Detect Acute Renal Failure
The purpose of this study is to find substances in the blood and urine that indicate that a person has kidney damage. It will identify proteins found only in patients with acute kidney failure but not in normal healthy people or in patients with volume depletion.
Adults and children who are at least 3 years old who fall into one of the following four categories may be eligible for this study:
Read more
- Are healthy and have normal kidney function
- Have volume depletion (this condition differs from acute kidney failure in that it is easily treated with fluids)
- Are at high risk of kidney failure
- Have acute kidney failure (kidney shutdown)
All study participants will have a history and physical examination. Up to four blood samples of 3 tablespoons each will be taken for laboratory analysis. Urine will be collected for analysis and to measure urine output. The participants length of stay in the study varies. People with normal kidney function will be in the study for 1 day and patients with volume depletion will be studied 3 days. The length of hospitalization of patients at high risk of kidney failure or in acute kidney failure will depend on the patient s condition and medication requirements.
The results of this study may lead to the development of earlier and more accurate methods for diagnosing acute kidney failure. With earlier detection, treatment could be started earlier, possibly preventing further damage and helping recovery of injury that has already occurred.
Read the detailed description
The mortality of acute renal failure (ARF) remains high despite advances in supportive care. There are no established effective drug therapies, and dialysis may promote renal injury via hypotension or neutrophil activation. Many agents [e.g., mannitol, furosemide, dopamine, Atrial Natriuretic Peptide (ANP), Insulin-like Growth Factor (IGF-1), thyroid hormone, etc.] are effective in animal models but ineffective in treating or preventing human ARF. The failure of these agents in human ARF may be due to late enrollment into the trial; effective therapy will likely require earlier detection.
The objective of this clinical study is to identify new biomarkers of renal injury, progression or recovery by analyzing urinary proteins during ARF. We will enroll patients with ARF, patients at high risk of ARF, patients with volume depletion, patients with urinary tract infection, patients with chronic kidney disease, and normal subjects. The diagnosis of pre-renal versus renal ARF will be made by routine clinical and laboratory testing. The level of renal dysfunction will be determined by creatinine clearance. Those patients at high risk for ARF will be followed prospectively and will undergo additional testing if ARF does develop. Patients will also be studied after creatinine levels return to normal. We will identify protein and/or microRNA biomarkers that are unique to patients with ARF,but not found in normal subjects or patients with volume depletion. It is hoped that some of these proteins may form the basis of new diagnostic tests for ARF.
- Conditions
- Kidney Disease, Kidney Failure, Kidney Failure, Chronic, Healthy Volunteers, Renal Tubular Toxicity
- Keywords
- Acute Kidney Injury
- Medical subject headings
- Kidney Diseases, Renal Insufficiency, Kidney Failure, Chronic, Acute Kidney Injury
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 |
|---|---|---|
| All | Subjects at least three years old |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimated GFR
Serum creatinine will be measured and eGFR will be calculated
Measured: at the time of sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2001 (estimated)
- Study start7 Jun 2000
- Primary completion12 Mar 2026
- Study completion12 Mar 2026
Why it stopped: The study is closing due to feasibility and resource limitations, with future work requiring a new study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- 226 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert A Star, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00026702
- Sponsor's protocol ID
- 000107
- Other IDs
- 00-DK-0107
- Status last verified
- Mar 2026
- First submitted
- 14 Nov 2001
- Last updated
- 13 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Search for Novel Methods to Detect Acute Renal Failure
- ClinicalTrials.gov ID
- NCT00026702
- Acronym / sponsor ID
- 000107
- Conditions
- Kidney Disease, Kidney Failure, Kidney Failure, Chronic, Healthy Volunteers, Renal Tubular Toxicity
- Keywords
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study is closing due to feasibility and resource limitations, with future work requiring a new study.
- Enrolment
- 226 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 7 Jun 2000 (actual)
- Primary completion
- 12 Mar 2026 (actual)
- Study completion
- 12 Mar 2026 (actual)
- First posted
- 15 Nov 2001 (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.
The purpose of this study is to find substances in the blood and urine that indicate that a person has kidney damage. It will identify proteins found only in patients with acute kidney failure but not in normal healthy people or in patients with volume depletion.
Adults and children who are at least 3 years old who fall into one of the following four categories may be eligible for this study:
- Are healthy and have normal kidney function
- Have volume depletion (this condition differs from acute kidney failure in that it is easily treated with fluids)
- Are at high risk of kidney failure
- Have acute kidney failure (kidney shutdown)
All study participants will have a history and physical examination. Up to four blood samples of 3 tablespoons each will be taken for laboratory analysis. Urine will be collected for analysis and to measure urine output. The participants length of stay in the study varies. People with normal kidney function will be in the study for 1 day and patients with volume depletion will be studied 3 days. The length of hospitalization of patients at high risk of kidney failure or in acute kidney failure will depend on the patient s condition and medication requirements.
The results of this study may lead to the development of earlier and more accurate methods for diagnosing acute kidney failure. With earlier detection, treatment could be started earlier, possibly preventing further damage and helping recovery of injury that has already occurred.
Detailed description
The mortality of acute renal failure (ARF) remains high despite advances in supportive care. There are no established effective drug therapies, and dialysis may promote renal injury via hypotension or neutrophil activation. Many agents [e.g., mannitol, furosemide, dopamine, Atrial Natriuretic Peptide (ANP), Insulin-like Growth Factor (IGF-1), thyroid hormone, etc.] are effective in animal models but ineffective in treating or preventing human ARF. The failure of these agents in human ARF may be due to late enrollment into the trial; effective therapy will likely require earlier detection.
The objective of this clinical study is to identify new biomarkers of renal injury, progression or recovery by analyzing urinary proteins during ARF. We will enroll patients with ARF, patients at high risk of ARF, patients with volume depletion, patients with urinary tract infection, patients with chronic kidney disease, and normal subjects. The diagnosis of pre-renal versus renal ARF will be made by routine clinical and laboratory testing. The level of renal dysfunction will be determined by creatinine clearance. Those patients at high risk for ARF will be followed prospectively and will undergo additional testing if ARF does develop. Patients will also be studied after creatinine levels return to normal. We will identify protein and/or microRNA biomarkers that are unique to patients with ARF,but not found in normal subjects or patients with volume depletion. It is hoped that some of these proteins may form the basis of new diagnostic tests for ARF.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All | – | –Subjects at least three years old |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- subjects with and without kidney disease, can include vulnerable populations such as pregnant women, cognitively impaired adults, or NIH employees
Key inclusion criteria (8 listed)
Key exclusion criteria (2 listed)
- Minors who do not give clear assent, even with parental consent
- Existence of any other condition which would complicate the implementation or interpretation of the study.
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
estimated GFR
Time frame: at the time of sample collection
Serum creatinine will be measured and eGFR will be calculated
Results and safety
The study was stopped early (reason given: The study is closing due to feasibility and resource limitations, with future work requiring a new study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Robert A Star, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 Kidney Disease and Kidney Failure, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 8 inclusion and 2 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: stopped early, as of the sponsor's last update on 13 Mar 2026. 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 was stopped early (reason given: The study is closing due to feasibility and resource limitations, with future work requiring a new study.). Results are not available in the source record.
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.
What does the primary outcome measure?
estimated GFR (time frame: at the time of sample collection). It is what the study was designed to measure, not a finding.
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 13 Mar 2026.