This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been terminated.
(no more recruitment in the centers)
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01572194
First received: March 28, 2012
Last updated: May 31, 2017
Last verified: May 2017
  Purpose

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.


Condition Intervention
Lung Transplantation Cystic Fibrosis Renal Failure Biological: Urinary levels of PIIINP as a marker of changes in renal function

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Predictive Value of PIIINP Urinary for the Development of Chronic Renal Failure in Patients With Cystic Fibrosis After Lung Transplantation.

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

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 [ Time Frame: 3 years ]

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. [ Time Frame: 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 ]
  • 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 ]

Enrollment: 45
Study Start Date: April 2012
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572194

Locations
France
Hourmant
Nantes, France, 44000
Sponsors and Collaborators
Nantes University Hospital
  More Information

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01572194     History of Changes
Other Study ID Numbers: RC11_0215
Study First Received: March 28, 2012
Last Updated: May 31, 2017

Keywords provided by Nantes University Hospital:
CF

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Renal Insufficiency
Kidney Failure, Chronic
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic

ClinicalTrials.gov processed this record on September 21, 2017