Iron DepositionERDFPNCT05593068
Iron Deposits in the Pancreas by MRI Method of Dialysis Patients With Hemosiderosis Iatrogenic (ERDFP)
An observational study of Iron Deposition and Dialysis, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Recently, a multidisciplinary scientific conference proposed to consider iron overload in dialysis patients as pathological only in the event of demonstration of radiological (in MRI), pancreatic or cardiac ferric deposits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deposition, Dialysis, Iatrogenic Hemosiderosis
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- How many people
- 185 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2022to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patient on hemodialysis or peritoneal dialysis at Claude Galien Private Hospital. They had to perform an MRI for iron quantification
Who may be able to join
- Male, female, over 18 years old
- Patient on hemodialysis or peritoneal dialysis at the Claude Galien Private Hospital
- Patient on dialysis who has undergone one (or more) abdominal MRI for iron quantification
- Patient who has signed a non-objection form for the retrospective use of their MRI, medical and biological data for the purpose of scientific study
Who cannot join
- Patient who has signed a form to object to the use of their health data
- Pregnant woman
- Poor adherence to the dialytic technique
- Severe cognitive impairment
- Hepatic cirrhosis
- Frank inflammatory syndrome or an active infectious disease
Show all 12Show fewer
- Genetic hemochromatosis and transfusion hemosiderosis of hemoglobinopathies and hematological diseases
- Recent major bleeding (< 3 months)
- Recent major surgery (< 3 months)
- Transfusion dependence
- Progressive malignant disease
- Pacemakers incompatible with an MRI and metal heart valves
Trial locations and contacts
1 site in 1 country.
Marie-Hélène Barba contact
France1 site
Hôpital Privé Claude Galien
Quincy-sous-Sénart, 91480
Guy ROSTOKER, Dr, 06 03 00 42 91, rostotom@orange.fr
About this study
Official title: Retrospective Study of Iron Deposits in the Pancreas by MRI Method of Dialysis Patients With Hemosiderosis Iatrogenic
Recently, a multidisciplinary scientific conference proposed to consider iron overload in dialysis patients as pathological only in the event of demonstration of radiological (in MRI), pancreatic or cardiac ferric deposits.
In this context, the aim of the proposed scientific study is to demonstrate the presence of ferric deposits in the pancreas by T2* MRI in dialysis patients with radiological hepatic iron overload, particularly in cases of moderate and severe iron overload.
- Conditions
- Iron Deposition, Dialysis, Iatrogenic Hemosiderosis
- Being tested
- MRI
- Medical subject headings
- Siderosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
Pancreatic MRI
| Study group | Role | What they receive |
|---|---|---|
| Dialysed patients with suspicion of hepatic iron | Patients on dialysis at Claude Galien Private Hospital who had one or more MRI scans to monitor possible hepatic iron overload between May 2012 and March 2018. Receives: Procedure: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of pancreatic iron deposit
Presence of pancreatic iron deposits as a function of hepatic iron level during iron overload in the dialysis patient will be evaluated from the pancreatic iron concentration measured by MRI and expressed by a T2* value in ms.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron DepositionStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593068
- Sponsor's protocol ID
- ERDFP
- Acronym
- ERDFP
- Status last verified
- Oct 2022
- First submitted
- 20 Oct 2022
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rostoker G, Griuncelli M, Francisco S, Loridon C, Languille-Llitjos E, Boulahia G, Cohen Y. Evidence of pancreatic iron deposits and their association with mortality in dialysis-associated iatrogenic hemosiderosis. Clin Kidney J. 2025 Oct 6;18(11):sfaf309. doi: 10.1093/ckj/sfaf309. eCollection 2025 Nov.
PubMed 41215782
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Iron Deposits in the Pancreas by MRI Method of Dialysis Patients With Hemosiderosis Iatrogenic
- ClinicalTrials.gov ID
- NCT05593068
- Acronym / sponsor ID
- ERDFP / ERDFP
- Conditions
- Iron Deposition, Dialysis, Iatrogenic Hemosiderosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 25 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recently, a multidisciplinary scientific conference proposed to consider iron overload in dialysis patients as pathological only in the event of demonstration of radiological (in MRI), pancreatic or cardiac ferric deposits.
In this context, the aim of the proposed scientific study is to demonstrate the presence of ferric deposits in the pancreas by T2* MRI in dialysis patients with radiological hepatic iron overload, particularly in cases of moderate and severe iron overload.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dialysed patients with suspicion of hepatic iron | – | Procedure: MRIPatients on dialysis at Claude Galien Private Hospital who had one or more MRI scans to monitor possible hepatic iron overload between May 2012 and March 2018. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patient on hemodialysis or peritoneal dialysis at Claude Galien Private Hospital. They had to perform an MRI for iron quantification
Key inclusion criteria (4 listed)
- Male, female, over 18 years old
- Patient on hemodialysis or peritoneal dialysis at the Claude Galien Private Hospital
- Patient on dialysis who has undergone one (or more) abdominal MRI for iron quantification
- Patient who has signed a non-objection form for the retrospective use of their MRI, medical and biological data for the purpose of scientific study
Key exclusion criteria (12 listed)
- Patient who has signed a form to object to the use of their health data
- Pregnant woman
- Poor adherence to the dialytic technique
- Severe cognitive impairment
- Hepatic cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIPancreatic MRI | Procedure or surgery | Dialysed patients with suspicion of hepatic iron |
Primary outcome
Presence of pancreatic iron deposit
Time frame: 1 day
Presence of pancreatic iron deposits as a function of hepatic iron level during iron overload in the dialysis patient will be evaluated from the pancreatic iron concentration measured by MRI and expressed by a T2* value in ms.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Derived from this study: PubMed 41215782Rostoker G, Griuncelli M, Francisco S, Loridon C, Languille-Llitjos E, Boulahia G, Cohen Y. Evidence of pancreatic iron deposits and their association with mortality in dialysis-associated iatrogenic hemosiderosis. Clin Kidney J. 2025 Oct 6;18(11):sfaf309. doi: 10.1093/ckj/sfaf309. eCollection 2025 Nov.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Hélène Barba contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deposition and Dialysis, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-François Oudet (0683346567, jeanfrancois.oudet@free.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of pancreatic iron deposit (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05593068, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.