Chronic Kidney DiseasePIPALNCT03520738
Tissue-nonspecific Alkaline Phosphatase in Phosphate and Pyrophosphate Homeostasis.
A study testing Blood samples and Urinary samples in people with Chronic Kidney Disease, run by Centre Hospitalier Universitaire de Nice at 4 sites in France.
Trial summary
Vascular calcification is a common finding in chronic kidney disease and increases arterial stiffness leading to augmented cardiovascular morbidity. The calcification process is thoroughly regulated by pro and anticalcifying agents. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Blood samples and Urinary samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 4 sitesFrance
- Study dates
- 15 May 2018to 6 Sep 2019
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with Chronic kidney disease (stage 1 or 2, 6 weeks after graft or patients on maintenance dialysis) or patient with pseudoxanthoma elasticum or patient with hypophosphatasia
- informed consent signed
Who cannot join
- cancer
- pregnancy
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU d'Angers - Service de Dermatologie
Angers
Service de Médecine Vacsulaire - CHU d'ANGERS
Angers
CHU de Nice
Nice
Service de Rhumatologie - Hôpital Cochin
Paris
About this study
Official title: Arterial Calcifications: Role of Tissue-nonspecific Alkaline Phosphatase in Phosphate and Pyrophosphate Homeostasis. PIPAL Study.
Vascular calcification is a common finding in chronic kidney disease and increases arterial stiffness leading to augmented cardiovascular morbidity. The calcification process is thoroughly regulated by pro and anticalcifying agents. The investigators hypothesize that imbalance in these compounds could depend on alkaline phosphatase activity. Therefore, the investigators will measure ALP activity, calcifications score, arterial stiffness and perform a bio-collection in monogenic rare diseases characterized by various levels of anticalcifying agents and in diverse CKD stages characterized by various levels of procalcifying compounds.
Read the detailed description
Chronic kidney disease (CKD) describes the gradual loss of kidney function from stage 1 (normal renal function) to stage 5 requiring maintenance dialysis or kidney transplantation (KT). Vascular calcification in CKD is a common finding and increases arterial stiffness leading to increased cardiovascular morbidity. The calcification process is the same for bones and arteries and is thoroughly regulated by pro and anticalcifying agents. Actually, inorganic phosphates (Pi) accelerate the calcification process and their levels are found increased in advanced CKD stage. In contrast, inorganic pyrophosphates (PPi) are potent anti-calcifying compounds resulting from the hydrolysis of extracellular ATP, but their role in CKD remains elusive. Tissue-nonspecific alkaline phosphatases (TNAP) convert PPi into Pi in calcification sites leading to hydroxyapatite deposition. The metabolism of PPi depends on diverse compounds, which are included in our bio-collection (Favre, Int J Mol Sci, 2017). The activity of plasma Alkaline Phosphatase (ALP) reflects the tissue production of TNAP. ALP activity is correlated to cardiovascular events in CKD patients. Preliminary results from our group show a stable plasma level of the PPi/Pi ratio independently from the glomerular filtration rate.
The investigators hypothesize that PPi/Pi imbalance could depend on ALP activity and could be a key determinant of vascular calcifications and arterial stiffness.
Therefore, the investigators will measure ALP activity, calcifications score, arterial stiffness and perform a bio-collection in monogenic rare diseases and in various CKD stages including hyperphosphatemic patients on maintenance hemodialysis.
Stage 1 and 2 CKD patients will be considered as a reference group because Pi levels and PPi levels are usually normal and calcification level is low. These patients will be compared to CKD patients with various Pi levels : low Pi levels in KT recipients 6 weeks after graft and high Pi levels in patients on maintenance dialysis. These patients (CKD 1 and 2) will be compared to patients with various PPi levels: patients with pseudoxanthoma elasticum (PXE) with low PPi levels and vascular calcifications and patients with hypophosphatasia (HPP) with high PPi levels and bone decalcification. PXE and HPP are rare monogenic disorder resulting from mutation in ABCC6 and the gene encoding TNAP respectively.
- Conditions
- Chronic Kidney Disease
- Being tested
- Blood samples, Urinary samples
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
Blood samples on an empty stomach
Urinary samplesOther
first urinary in the morning
| Study group | Role | What they receive |
|---|---|---|
| Chronic Kidney Disease | Other | Blood and urinary samples on the following patients:
10 Stage 1 and 2 CKD patients 10 patients 6 weeks after graft 10 patients on maintenance dialysis. Receives: Other: Blood samples; Other: Urinary samples |
| Pseudoxanthoma elasticum (PXE) | Other | Blood and urinary samples on the following patients:
10 patients with pseudoxanthoma elasticum (PXE) with low PPi levels and vascular calcifications and patients with hypophosphatasia (HPP) with high PPi levels and bone decalcification. Receives: Other: Blood samples; Other: Urinary samples |
| Hypophosphatasia (HPP) | Other | Blood and urinary samples on the following patients:
4 patients with hypophosphatasia (HPP) with high PPi levels and bone decalcification. Receives: Other: Blood samples; Other: Urinary samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
ALP activity (alkaline phosphatase activity)
ALP activity will be plotted against the PPi/Pi ratio in CKD patients with various Pi levels; a regression curve will be used to measure the correlation between these two factors
Measured: at time = day 0 (inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start15 May 2018
- Primary completion6 Sep 2019
- Study completion6 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume FAVRE, MD, Principal investigator, Nephrology Department, Nice University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520738
- Sponsor's protocol ID
- 17-AOIP-01
- Acronym
- PIPAL
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2018
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Calcifications: Role of Tissue-nonspecific Alkaline Phosphatase in Phosphate and Pyrophosphate Homeostasis. PIPAL Study.
- ClinicalTrials.gov ID
- NCT03520738
- Acronym / sponsor ID
- PIPAL / 17-AOIP-01
- Conditions
- Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 6 Sep 2019 (actual)
- Study completion
- 6 Sep 2019 (actual)
- First posted
- 11 May 2018 (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.
Vascular calcification is a common finding in chronic kidney disease and increases arterial stiffness leading to augmented cardiovascular morbidity. The calcification process is thoroughly regulated by pro and anticalcifying agents. The investigators hypothesize that imbalance in these compounds could depend on alkaline phosphatase activity. Therefore, the investigators will measure ALP activity, calcifications score, arterial stiffness and perform a bio-collection in monogenic rare diseases characterized by various levels of anticalcifying agents and in diverse CKD stages characterized by various levels of procalcifying compounds.
Detailed description
Chronic kidney disease (CKD) describes the gradual loss of kidney function from stage 1 (normal renal function) to stage 5 requiring maintenance dialysis or kidney transplantation (KT). Vascular calcification in CKD is a common finding and increases arterial stiffness leading to increased cardiovascular morbidity. The calcification process is the same for bones and arteries and is thoroughly regulated by pro and anticalcifying agents. Actually, inorganic phosphates (Pi) accelerate the calcification process and their levels are found increased in advanced CKD stage. In contrast, inorganic pyrophosphates (PPi) are potent anti-calcifying compounds resulting from the hydrolysis of extracellular ATP, but their role in CKD remains elusive. Tissue-nonspecific alkaline phosphatases (TNAP) convert PPi into Pi in calcification sites leading to hydroxyapatite deposition. The metabolism of PPi depends on diverse compounds, which are included in our bio-collection (Favre, Int J Mol Sci, 2017). The activity of plasma Alkaline Phosphatase (ALP) reflects the tissue production of TNAP. ALP activity is correlated to cardiovascular events in CKD patients. Preliminary results from our group show a stable plasma level of the PPi/Pi ratio independently from the glomerular filtration rate.
The investigators hypothesize that PPi/Pi imbalance could depend on ALP activity and could be a key determinant of vascular calcifications and arterial stiffness.
Therefore, the investigators will measure ALP activity, calcifications score, arterial stiffness and perform a bio-collection in monogenic rare diseases and in various CKD stages including hyperphosphatemic patients on maintenance hemodialysis.
Stage 1 and 2 CKD patients will be considered as a reference group because Pi levels and PPi levels are usually normal and calcification level is low. These patients will be compared to CKD patients with various Pi levels : low Pi levels in KT recipients 6 weeks after graft and high Pi levels in patients on maintenance dialysis. These patients (CKD 1 and 2) will be compared to patients with various PPi levels: patients with pseudoxanthoma elasticum (PXE) with low PPi levels and vascular calcifications and patients with hypophosphatasia (HPP) with high PPi levels and bone decalcification. PXE and HPP are rare monogenic disorder resulting from mutation in ABCC6 and the gene encoding TNAP respectively.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronic Kidney Disease | Other | Other: Blood samples, Other: Urinary samplesBlood and urinary samples on the following patients: 10 Stage 1 and 2 CKD patients 10 patients 6 weeks after graft 10 patients on maintenance dialysis. |
| Pseudoxanthoma elasticum (PXE) | Other | Other: Blood samples, Other: Urinary samplesBlood and urinary samples on the following patients: 10 patients with pseudoxanthoma elasticum (PXE) with low PPi levels and vascular calcifications and patients with hypophosphatasia (HPP) with high PPi levels and bone decalcification. |
| Hypophosphatasia (HPP) | Other | Other: Blood samples, Other: Urinary samplesBlood and urinary samples on the following patients: 4 patients with hypophosphatasia (HPP) with high PPi levels and bone decalcification. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient with Chronic kidney disease (stage 1 or 2, 6 weeks after graft or patients on maintenance dialysis) or patient with pseudoxanthoma elasticum or patient with hypophosphatasia
- informed consent signed
Key exclusion criteria (2 listed)
- cancer
- pregnancy
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 |
|---|---|---|
| Blood samplesBlood samples on an empty stomach | Other | Chronic Kidney Disease, Hypophosphatasia (HPP), Pseudoxanthoma elasticum (PXE) |
| Urinary samplesfirst urinary in the morning | Other | Chronic Kidney Disease, Hypophosphatasia (HPP), Pseudoxanthoma elasticum (PXE) |
Primary outcome
ALP activity (alkaline phosphatase activity)
Time frame: at time = day 0 (inclusion)
ALP activity will be plotted against the PPi/Pi ratio in CKD patients with various Pi levels; a regression curve will be used to measure the correlation between these two factors
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Guillaume FAVRE, MD principal investigator
Nephrology Department, Nice University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples and Urinary samples in people with Chronic Kidney Disease, run by Centre Hospitalier Universitaire de Nice at 4 sites 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ALP activity (alkaline phosphatase activity) (time frame: at time = day 0 (inclusion)). 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 11 Apr 2024.