Liver CirrhosisPYROCALMNCT07201649
Roles of Hepatic Insufficiency, Hepatic Fibrosis, and Inorganic Pyrophosphate in the Progression of Arterial Calcifications
A study testing a blood test and urine sample collection. in people with Liver Cirrhosis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Individuals with metabolic syndrome (MetS), particularly those with type 2 diabetes (T2D), and/or metabolic dysfunction-associated steatohepatitis or MASH face an elevated risk of major cardiovascular events (MACE). We showed decrease plams level of PPi in patients with liver cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- a blood test and urine sample collection.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteFrance
- Study dates
- 24 Nov 2025to 24 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- everyone requiring liver transplantation for the treatment of a chronic liver disease
Who cannot join
- MELD score >25, viral replication
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nice
Nice, Alpes-maritimes, 06200
Guillaume FAVRE, PhD, +33492039220, favre.g@chu-nice.fr
Guillaume FAVRE, PhD
About this study
Individuals with metabolic syndrome (MetS), particularly those with type 2 diabetes (T2D), and/or metabolic dysfunction-associated steatohepatitis or MASH face an elevated risk of major cardiovascular events (MACE). We showed decrease plams level of PPi in patients with liver cirrhosis. We hypothezised that liver transplant should block AC and restore PPi plasma level.
- Conditions
- Liver Cirrhosis
- Being tested
- a blood test and urine sample collection.
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a blood test and urine sample collection.Other
The study is offered to all patients who meet the inclusion criteria during their pre-transplant assessment by the principal investigator (during an existing visit). Patients eligible for HT are contacted by a clinical research coordinator, and if they agree, an inclusion visit is arranged.
| Study group | Role | What they receive |
|---|---|---|
| Patients eligible for Hepatit Transplantation | Other | Patients eligible for HT are contacted by a clinical research coordinator, and if they agree, an inclusion visit is arranged. HT takes place according to transplant availability. As soon as the patient is able to return home after HT, a visit is organised, defining the T1 period. A visit is carried out 120 days after HT and the end-of-study visit is scheduled to define the T2 period, which is the same length as the T1 period for each patient. Receives: Other: a blood test and urine sample collection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
hepatic transplantation reduces arterial calcification
compare the percent of patients with AC progression before and after liver tranplantation
Measured: On the 7th day after surgery
Secondary outcomes (2)
identify arterial calcification related factors
separation of patients according to AC progression (yes or no) and machine learning analysis with all relevant factors
Measured: On the 7th day after surgery
increase of PPi plasma level after liver transplantation
comparison of mean plasma levels before and after
Measured: at inclusion and at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start24 Nov 2025
- Primary completion24 Nov 2028 (estimated)
- Study completion24 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume FAVRE, PhD, Principal investigator, CRC, Néphrologie - CHU de Nice - Hôpital de l'Archet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201649
- Sponsor's protocol ID
- 24-PP-15
- Acronym
- PYROCALM
- Status last verified
- Nov 2025
- First submitted
- 22 Sep 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Roles of Hepatic Insufficiency, Hepatic Fibrosis, and Inorganic Pyrophosphate in the Progression of Arterial Calcifications
- ClinicalTrials.gov ID
- NCT07201649
- Acronym / sponsor ID
- PYROCALM / 24-PP-15
- Conditions
- Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- 24 Nov 2028 (estimated)
- Study completion
- 24 Nov 2029 (estimated)
- First posted
- 1 Oct 2025 (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.
Individuals with metabolic syndrome (MetS), particularly those with type 2 diabetes (T2D), and/or metabolic dysfunction-associated steatohepatitis or MASH face an elevated risk of major cardiovascular events (MACE). We showed decrease plams level of PPi in patients with liver cirrhosis. We hypothezised that liver transplant should block AC and restore PPi plasma level.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients eligible for Hepatit Transplantation | Other | Other: a blood test and urine sample collection.Patients eligible for HT are contacted by a clinical research coordinator, and if they agree, an inclusion visit is arranged. HT takes place according to transplant availability. As soon as the patient is able to return home after HT, a visit is organised, defining the T1 period. A visit is carried out 120 days after HT and the end-of-study visit is scheduled to define the T2 period, which is the same length as the T1 period for each patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- everyone requiring liver transplantation for the treatment of a chronic liver disease
Key exclusion criteria (1 listed)
- MELD score >25, viral replication
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 |
|---|---|---|
| a blood test and urine sample collection.The study is offered to all patients who meet the inclusion criteria during their pre-transplant assessment by the principal investigator (during an existing visit). Patients eligible for HT are contacted by a clinical research coordinator, and if they agree, an inclusion visit is arranged. | Other | Patients eligible for Hepatit Transplantation |
Primary outcome
hepatic transplantation reduces arterial calcification
Time frame: On the 7th day after surgery
compare the percent of patients with AC progression before and after liver tranplantation
2 secondary outcomes
identify arterial calcification related factors
Time frame: On the 7th day after surgery
increase of PPi plasma level after liver transplantation
Time frame: at inclusion and at 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
Guillaume FAVRE, PhD principal investigator
CRC, Néphrologie - CHU de Nice - Hôpital de l'Archet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a blood test and urine sample collection. in people with Liver Cirrhosis, run by Centre Hospitalier Universitaire de Nice 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 1 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume FAVRE, PhD (+33492039220, favre.g@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hepatic transplantation reduces arterial calcification (time frame: On the 7th day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2025.