Identification and Validation of Biomarkers of Acute Kidney Injury Recovery

Acute Kidney Injury Clinical Trial

Official title:

Identification and Validation of Biomarkers of Acute Kidney Injury Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01868724
• Other study ID #: Ruby
• Status: Completed
• Phase: N/A
• First received: May 21, 2013
• Last updated: March 12, 2015
• Start date: June 2013
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: Astute Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This study is to collect blood and urine samples to help identify and validate protein biomarkers of recovery from moderate or severe acute kidney injury (AKI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 362
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:a.

• Males and females 21 years of age or older

• Receiving care in an intensive care unit

• Expected to remain in the ICU for at least 48 hours after enrollment

• Use of indwelling urinary catheter as standard care at the time of enrollment

• Subject must have acute kidney injury (KDIGO stage 2 or stage 3) at the time of the first sample collection

• First sample must be collected within 36 hours of meeting KDIGO stage 2 criteria

• Written informed consent provided by patient or legally authorized representative (LAR)

Exclusion Criteria:

• Prior kidney transplantation

• Comfort-measures-only status

• Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment

• History of human immunodeficiency virus (HIV) or hepatitis virus (based upon available medical records) infections (NOTE: HIV or hepatitis testing need not be performed for enrollment in this study.)

• Special populations, pregnant women, prisoners or institutionalized individuals

• Patient meets any of the following:

• Active bleeding with an anticipated need for > 4 units PRBC in a day

• Hemoglobin < 7 g/dL

• Any other condition that in the physician's opinion would contraindicate drawing serial blood samples for clinical study purposes

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astute Medical, Inc.

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of biomarkers for Acute Kidney Injury Recovery in Blood or Urine.	This study is a multi-center study intended to enroll enough subjects to validate biomarkers for acute kidney injury recovery. Subjects enrolled will be those with known moderate to severe AKI. The study is to determine the outcome of Major Adverse Kidney Event (MAKE) and Major Adverse Cardiac Event (MACE) during a period of up to 7 days.	Day 1-7 of enrollment	No
Secondary	None at this time	There are no secondary outcomes measures planned at this time	10 months	No