Predictive Value of PIIINP and Urinary NGAL for the Development of Chronic Renal Failure in Patients With Cystic Fibrosis After Lung Transplantation (MUCO-IRC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01572194
First received: March 28, 2012
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

Chronic renal failure is a serious complication of lung transplantation especially in patients with cystic fibrosis. Their medical history prior to the Lung Transplantation has already exposed to kidney damage. Post-lung transplantation, these patients are subjected to renal toxicity anticalcineurins they receive large doses.

The measurement of renal function of patients by formula to estimate GFR in routine use is unreliable and other markers seem indispensable.

The purpose of this study is to evaluate two markers, PIIINP (Procollagen III aminoterminal peptide N), whose urinary levels was correlated to the intensity of fibrosis in different types of kidney disease and NGAL (Neutrophil gelatinase Associated lipocalin) that play a role in the transition of the lesions of acute renal failure to chronic lesions of glomerular and interstitial fibrosis.


Condition Intervention
Lung Transplantation
Cystic Fibrosis
Renal Failure
Biological: Urinary levels of PIIINP and NGAL as a marker of changes in renal function

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Predictive Value of PIIINP and Urinary NGAL for the Development of Chronic Renal Failure in Patients With Cystic Fibrosis After Lung Transplantation.

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • The correlation between the rate of urinary PIIINP inclusion in the study and the variation of the isotopic measurement of GFR over the 2 year study [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Description of histological lesions present after transplantation from renal biopsies performed in all patients with chronic renal failure defined by a GFR between 30 and 60 ml / min and / or proteinuria> 1 g / d. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Correlation between the rate of PIIINP urinary NGAL and the rate of first and second intensity of renal fibrosis histologically assessed renal biopsies that have been conducted in patients. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Correlation between the rate of urinary PIIINP and glomerular filtration rate measured by scintigraphy Chrome-EDTA at study entry and after 2 years of follow-up [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Correlation between the rate of urinary NGAL and GFR measured by scintigraphy Chrome-EDTA at study entry and after 2 years of follow-up [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Correlation between the rate of urinary NGAL to the inclusion in the study and the variation of the isotopic measurement of GFR over the 2 year study. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 95
Study Start Date: April 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Urinary levels of PIIINP and NGAL as a marker of changes in renal function
    The act under consideration is the determination of PIIINP and urinary NGAL. The aim of the study is to show the predictive value of PIIINP and urinary NGAL in assessing renal function in patients with mucoviscidosis receiving a lung transplant.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Bearer of lung transplantation (single or double lung, with or without associated cardiac transplantation)
  • Suffering from cystic fibrosis
  • Aged 18 and over
  • With at least 6 months of transplantation
  • Having a glomerular filtration rate measured by technical radionuclide > 30 ml / min
  • Having given written consent to the study Patients meeting these criteria will enter in the "organic" in the study (determination of PIIINP and urinary NGAL)

Exclusion Criteria:

  • Lung transplantation for a condition other than cystic fibrosis
  • Patient refused follow-up
  • Patients with advanced liver disease (conditions that interfere with the assay of PIIINP)
  • Minor
  • Pregnant women,
  • Major Trust, benefiting from a regime of legal protection (guardianship, trusteeship, safeguarding justice.
  • Patient unable to grant informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572194

Locations
France
Hourmant Recruiting
Nantes, France, 44000
Contact: Maryvonne Hourmant, PU-PH       maryvonne.hourmant@chu-nantes.fr   
Principal Investigator: Catherine Amrein, PH         
Principal Investigator: Moglie Le Quintrec-Donnette, PH         
Principal Investigator: Martine Reynaud-Gaubert, PU-PH         
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01572194     History of Changes
Other Study ID Numbers: RC11_0215_01
Study First Received: March 28, 2012
Last Updated: February 19, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
CF

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Kidney Failure, Chronic
Renal Insufficiency
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 01, 2014