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

23 juni 2026 uppdaterad av: Nantes University Hospital

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

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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

287

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Nantes, Frankrike, 44093
        • CHU de Nantes

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Patients experimenting ARF in ATN context.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
PIIINP/Urinary Creatinine ratio levels between patients experimenting CRF or not.
Tidsram: 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).
12months after initial diagnosis.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
NGAL/Urinary Creatinine ratio levels between patients experimenting CRF or not.
Tidsram: 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).
12, 18 and 24 months after initial diagnosis.
Correlation between NGAL/Urinary Creatinine and PIIINP/Urinary Creatinine ratios among patients with ARF.
Tidsram: 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, 6, 12, 18 or 24 months after initial diagnosis.
Validation of high diagnostic performance of NGAL/Urinary Creatinine ratio to predict CRF occurrence.
Tidsram: 3, 6, 12, 18 or 24 months after initial diagnosis.
Sensitivity of NGAL/Urinary Creatinine ratio will be assessed at each time frame.
3, 6, 12, 18 or 24 months after initial diagnosis.
Validation of high diagnostic performance of PIIINP/Urinary Creatinine to predict CRF occurrence.
Tidsram: 3, 6, 12, 18 or 24 months after initial diagnosis.
Sensitivity of PIIINP/Urinary Creatinine ratio will be assessed at each time frame.
3, 6, 12, 18 or 24 months after initial diagnosis.

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2012

Primärt slutförande (Faktisk)

1 oktober 2014

Avslutad studie (Faktisk)

1 februari 2016

Studieregistreringsdatum

Först inskickad

24 augusti 2016

Först inskickad som uppfyllde QC-kriterierna

30 augusti 2016

Första postat (Beräknad)

5 september 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

24 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 juni 2026

Senast verifierad

1 augusti 2016

Mer information

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