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

Not Applicable

Terminated

• Conditions: Renal Failure; Lung Transplantation; Cystic Fibrosis

• Registration Number: NCT01572194
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-28
• Study Start: 2012-04
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-06
• Status Verified: 2017-05
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Last Update Submitted: 2018-04-20
• Last Update Posted: 2018-04-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hourmant; 🇫🇷 Nantes, France