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

April 20, 2018 updated by: Nantes University Hospital

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44000
        • Hourmant

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
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.
Time Frame: 3 years
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.
Time Frame: 3 years
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
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

March 28, 2012

First Submitted That Met QC Criteria

April 4, 2012

First Posted (Estimate)

April 6, 2012

Study Record Updates

Last Update Posted (Actual)

April 23, 2018

Last Update Submitted That Met QC Criteria

April 20, 2018

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC11_0215

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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