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

NCT ID: NCT01572194

Last Updated: 2018-04-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2018-04-30

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.

Conditions

Lung Transplantation; Cystic Fibrosis; Renal Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hourmant

Nantes, , France

Countries

France

Other Identifiers

RC11_0215

Identifier Type: -

Identifier Source: org_study_id