Predictive Value of PIIINP and Urinary NGAL in Renal Function Recovery

NCT02889575 | Completed

• 1 other identifier: PROG/11/59
• Study Type: observational
• Target: 287
• Locations: 0 countries
• Sites: N/A

Brief Summary

Acute Renal Failure (ARF) is defined by a severe, and usually reversible, glomerular filtration rate decreasing. Acute Tubular Necrosis (ATN) remain the major cause of ARF involving distress and destruction of tubular cells. This specific typology of ARF may evolve toward Chronic Renal Failure (CRF) concretizing a major public health issue. Predict the progression of ARF towards CRF appears essential. The investigators believe that the PIIINP and urinary NGAL biomarkers may constitute robust biomarkers of progression risk towards CRF.

Conditions

Acute Renal Failure; Acute Kidney Tubular Necrosis; Chronic Kidney Failure

Outcome Measures

Primary Outcomes (1)

• PIIINP/Urinary Creatinine ratio levels between patients experimenting CRF or not.

  We expect to highlight different ratio PIIINP/Urinary Creatinine levels and evolution between patients experimenting CRF or not (defined less than 60 mL/min according MDRD formula).

  12months after initial diagnosis.

Secondary Outcomes (4)

• NGAL/Urinary Creatinine ratio levels between patients experimenting CRF or not.

  12, 18 and 24 months after initial diagnosis.

• Correlation between NGAL/Urinary Creatinine and PIIINP/Urinary Creatinine ratios among patients with ARF.

  3, 6, 12, 18 or 24 months after initial diagnosis.

• Validation of high diagnostic performance of NGAL/Urinary Creatinine ratio to predict CRF occurrence.

  3, 6, 12, 18 or 24 months after initial diagnosis.

• Validation of high diagnostic performance of PIIINP/Urinary Creatinine to predict CRF occurrence.

  3, 6, 12, 18 or 24 months after initial diagnosis.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients experimenting ARF in ATN context.

You may qualify if:

• off-age patient.
• ATN diagnosis based on 1) typical clinical environment (sepsis, nephrotoxicity...) 2) 50% decrease of glomerular filtration flow (according clearance MDRD) or more than 100micromol plasmatic creatinine increase. 3) no renal function improvement after efficient vascular filling (\>750cc normal saline or equivalent).
• Consent.

You may not qualify if:

• ARF not related with ATN context.
• Life expectancy less than 3 months.
• Protocol refusal

Sponsors & Collaborators

• Nantes University Hospital: lead

MeSH Terms

Conditions

Acute Kidney Injury; Kidney Tubular Necrosis, Acute; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; 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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 5, 2016
• Study Start: April 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: February 1, 2016
• Last Updated: September 7, 2016

Record last verified: 2016-08