Clinical trial NCT01572194: Predictive Value of PIIINP Urinary for the Development of Chronic Renal Failure in Patients With Cystic Fibrosis After Lung Transplantation (MUCO-IRC)
Official title: Predictive Value of PIIINP Urinary for the Development of Chronic Renal Failure in Patients With Cystic Fibrosis After Lung Transplantation.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Transplantation
Cystic Fibrosis
Renal Failure
Keywords: CF
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2012-04-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility 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 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.

Primary outcomes:
measure: 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
timeFrame: 3 years
Secondary outcomes:
measure: 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.
timeFrame: 3 years
measure: 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.
timeFrame: 3 years
measure: 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
timeFrame: 3 years
Other outcomes:
Locations:
city: Nantes
country: France
facility: Hourmant
Study officials:
References: