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

Primary Purpose

Lung Transplantation, Cystic Fibrosis, Renal Failure

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Urinary levels of PIIINP as a marker of changes in renal function
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Transplantation focused on measuring CF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hourmant

Outcomes

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

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.
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.
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

Full Information

First Posted
March 28, 2012
Last Updated
April 20, 2018
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01572194
Brief Title
Predictive Value of PIIINP Urinary for the Development of Chronic Renal Failure in Patients With Cystic Fibrosis After Lung Transplantation (MUCO-IRC)
Acronym
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
no more recruitment in the centers
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Transplantation, Cystic Fibrosis, Renal Failure
Keywords
CF

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Urinary levels of PIIINP as a marker of changes in renal function
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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.
Time Frame
3 years
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hourmant
City
Nantes
ZIP/Postal Code
44000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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