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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01572194
• Date of registration: 28/03/2012
• Prospective Registration: Yes
• Primary sponsor: Nantes University Hospital
• Public title: Predictive Value of PIIINP Urinary for the Development of Chronic Renal Failure in Patients With Cystic Fibrosis After Lung Transplantation (MUCO-IRC) MUCO-IRC
• Scientific title: Predictive Value of PIIINP Urinary for the Development of Chronic Renal Failure in Patients With Cystic Fibrosis After Lung Transplantation.
• Date of first enrolment: April 2012
• Target sample size: 45
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01572194
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Renal Failure

Cystic Fibrosis

Lung Transplantation

Intervention(s)

Biological: Urinary levels of PIIINP as a marker of changes in renal function

Primary Outcome(s)

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(s)

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 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]

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]

Secondary ID(s)

RC11_0215

Source(s) of Monetary Support

Please refer to primary and secondary sponsors