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

NCT01572194 | Terminated

• 1 other identifier: RC11_0215
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

CF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• 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

Interventions

Urinary levels of PIIINP as a marker of changes in renal function BIOLOGICAL

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Hourmant

Nantes, 44000, France

Location

MeSH Terms

Conditions

Cystic Fibrosis; Renal Insufficiency

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: April 6, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 23, 2018

Record last verified: 2017-05

Locations

FR (1)