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

Cystic Fibrosis Clinical Trial

— MUCO-IRC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01572194
• Other study ID #: RC11_0215
• Status: Terminated
• Phase: N/A
• First received: March 28, 2012
• Last updated: April 20, 2018
• Start date: April 2012
• Est. completion date: April 2018

Study information

• Verified date: May 2017
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Kidney Failure, Chronic
• Lung Transplantation
• Renal Failure
• Renal Insufficiency

Intervention

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.

Locations

Country	Name	City	State
France	Hourmant	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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