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

Study Overview
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Brief Summary
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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.

Official Title
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Predictive Value of PIIINP Urinary for the Development of Chronic Renal Failure in Patients With Cystic Fibrosis After Lung Transplantation.

Conditions
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Lung Transplantation, Cystic Fibrosis, Renal Failure

Intervention / Treatment
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* Biological: Urinary levels of PIIINP as a marker of changes in renal function


Participation Criteria
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Eligibility Criteria
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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 urinary) 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Urinary levels of PIIINP as a marker of changes in renal function|The act under consideration is the determination of PIIINP urinary. The aim of the study is to show the predictive value of PIIINP urinary in assessing renal function in patients with mucoviscidosis receiving a lung transplant.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 3 years | 
| Correlation between the rate of PIIINP urinary and the rate of first and second intensity of renal fibrosis histologically assessed renal biopsies that have been conducted in patients. |  | 3 years | 
| 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 |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CF