Predictive Value of PIIINP Urinary for the Development of Chronic Renal Failure in Patients With … (NCT01572194) | Clinical Trial Compass
TerminatedNot Applicable
Predictive Value of PIIINP Urinary for the Development of Chronic Renal Failure in Patients With Cystic Fibrosis After Lung Transplantation (MUCO-IRC)
Stopped: no more recruitment in the centers
France45 participantsStarted 2012-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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