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Predictive Value of PIIINP and Urinary NGAL in Renal Function Recovery (PIIINP-NGAL)

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ClinicalTrials.gov Identifier: NCT02889575
Recruitment Status : Completed
First Posted : September 5, 2016
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.


Condition or disease
Acute Renal Failure Acute Kidney Tubular Necrosis Chronic Kidney Failure

Detailed Description:

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 progression risk appear in recent years: the Procollagen III N-terminal peptide (PIIINP) and the neutrophil gelatinase associated lipocalin (NGAL). The investigators believe that the PIIINP and urinary NGAL may constitute robust biomarkers of progression (or not) towards CRF in ARF context. Firstly, PIIINP is a good reflection of fibrosis process inside the kidney. Secondarily, NGAL is a marker of renal tubule remodeling after renal aggression. The combination of these two biomarkers could therefore efficiently reflect the balance tubular fibrosis/restoration and may allow optimal prediction of renal function recovery.

The investigators hypothesize that these two biomarkers may be used to assess the risk of CRF progression during ARF in ATN context.


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Study Type : Observational
Actual Enrollment : 287 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Multicenter Study to Assess the Predictive Value of PIIINP and Urinary NGAL in Renal Function Recovery During Acute Tubular Necrosis
Study Start Date : April 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients experimenting ARF in ATN context.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02889575     History of Changes
Other Study ID Numbers: PROG/11/59
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Renal Insufficiency
Necrosis
Acute Kidney Injury
Kidney Failure, Chronic
Kidney Cortex Necrosis
Kidney Tubular Necrosis, Acute
Kidney Diseases
Urologic Diseases
Pathologic Processes
Renal Insufficiency, Chronic