Clinical Trial: Predictive Value of PIIINP and Urinary NGAL in Renal Function Recovery

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Prospective Multicenter Study to Assess the Predictive Value of PIIINP and Urinary NGAL in Renal Function Recovery During Acute Tubular Necrosis

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.


Detailed Summary:

Acute Renal Failure (ARF) is defined by a severe, and usually reversible, glomerular filtration rate decreasing. Beside its frequency, ARF may be associated with severe prognostic. Thus, patient admitted in ICU and suffering of ARF requiring dialysis, had a higher risk of mortality up to 50%.

Tubulointerstitial nephropathies, particularly Acute Tubular Necrosis (ATN) remain the major cause of ARF, representing 45-50% of cases. The ATN is due to suffering and destruction of tubular cells which are very sensitive to ischemia-reperfusion lesions because tubular reabsorption functions require significant and constant energy intake. However, ATN represents a relatively homogeneous group in terms of acute kidney disease typology. Homogeneity and significant frequency compels ATN as an optimal model to study function recovery after ARF.

ARF constitutes a major public health issue. Actually, incidence of Chronic Renal Failure (CRF) after an ARF, due to ATN, is estimated between 19% and 31%. In addition 12.5% of patients with specific ARF presentation immediately reach End-stage Renal Disease (ESRD), and the occurrence of ARF requiring dialysis, triples the risk of chronic renal support.

Therefore, predict the progression of ARF towards CRF appears essential.

At this time, the investigators currently lack of reliable biomarkers to predict such progression. This pejorative kidney development is due to the persistence of intrarenal inflammation, rapid development of interstitial fibrosis and deficiency in tubular restoration. It involves complex mechanisms of inflammatory response, and vascular and tubular remodeling.

Two promising biomarkers of renal fibrosis, ARF occurrence and CRF pr
Sponsor: Nantes University Hospital

Current Primary Outcome: PIIINP/Urinary Creatinine ratio levels between patients experimenting CRF or not. [ Time Frame: 12months after initial diagnosis. ]

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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • NGAL/Urinary Creatinine ratio levels between patients experimenting CRF or not. [ Time Frame: 12, 18 and 24 months after initial diagnosis. ]
    We expect to highlight different ratio NGAL/Urinary Creatinine levels and evolution between patients experimenting CRF or not (defined less than 60 mL/min according MDRD formula).
  • Correlation between NGAL/Urinary Creatinine and PIIINP/Urinary Creatinine ratios among patients with ARF. [ Time Frame: 3, 6, 12, 18 or 24 months after initial diagnosis. ]
    We expect to highlight linear correlation between NGAL/Urinary Creatinine and PIIINP/Urinary Creatinine ratios among patients with ARF.
  • Validation of high diagnostic performance of NGAL/Urinary Creatinine ratio to predict CRF occurrence. [ Time Frame: 3, 6, 12, 18 or 24 months after initial diagnosis. ]
    Sensitivity of NGAL/Urinary Creatinine ratio will be assessed at each time frame.
  • Validation of high diagnostic performance of PIIINP/Urinary Creatinine to predict CRF occurrence. [ Time Frame: 3, 6, 12, 18 or 24 months after initial diagnosis. ]
    Sensitivity of PIIINP/Urinary Creatinine ratio will be assessed at each time frame.


Original Secondary Outcome: Same as current

Information By: Nantes University Hospital

Dates:
Date Received: August 24, 2016
Date Started: April 2012
Date Completion:
Last Updated: September 5, 2016
Last Verified: August 2016