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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)

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01572194
Acronym
MUCO-IRC
Enrollment
45
Registered
2012-04-06
Start date
2012-04-30
Completion date
2018-04-30
Last updated
2018-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis, Lung Transplantation, Renal Failure

Keywords

CF

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.

Interventions

BIOLOGICALUrinary 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.

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime 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 study3 years

Secondary

MeasureTime 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.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-up3 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026