Search for New Methods to Detect Acute Renal Failure

NCT00026702 | Terminated

• 2 other identifiers: 00010700-DK-0107
• Study Type: observational
• Target: 226
• Locations: 1 country
• Sites: 1

Brief 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. 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:

1. 1.Are healthy and have normal kidney function
2. 2.Have volume depletion (this condition differs from acute kidney failure in that it is easily treated with fluids)
3. 3.Are at high risk of kidney failure
4. 4.Have acute kidney failure (kidney shutdown)

Conditions

Kidney Disease; Kidney Failure; Kidney Failure, Chronic; Healthy Volunteers; Renal Tubular Toxicity

Keywords

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• estimated GFR

  Serum creatinine will be measured and eGFR will be calculated

  at the time of sample collection

Study Arms (1)

All

Subjects at least three years old

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

subjects with and without kidney disease, can include vulnerable populations such as pregnant women, cognitively impaired adults, or NIH employees

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Kidney Diseases; Renal Insufficiency; Kidney Failure, Chronic; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert A Star, M.D.

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2001
• First Posted: November 15, 2001
• Study Start: June 7, 2000
• Primary Completion: March 12, 2026
• Study Completion: March 12, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (1)