End-Stage Renal Disease (ESRD)CIPHEMONCT03119818
Intracellular Phosphate Concentration Evolution During Hemodialysis by MR Spectroscopy
A study testing Phosphorus (31P) magnetic resonance spectroscopy and Hemodialysis in people with End-Stage Renal Disease (ESRD), run by Hospices Civils de Lyon at 1 site in France.
Trial summary
End-stage renal disease is associated with hyperphosphatemia due to a decrease of renal phosphate excretion. This hyperphosphatemia is associated with an increase of cardiovascular risk and mortality. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End-Stage Renal Disease (ESRD)
- What is being tested?
- Phosphorus (31P) magnetic resonance spectroscopy and Hemodialysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jun 2017to 29 Jul 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient suffering from end-stage renal disease, treated by chronic hemodialysis since at less 6 months
- Phosphatemia (at the start of the session) ≥ 1,5 mmol/L and ≤ 3 mmol/L
- written consent signed
Who cannot join
- Major subject protected by law
- Prisoners or subjects who are involuntarily incarcerated
- Denutrition (weight loss ≥ 5 kg in one months/10 kg in 6 months, Body Mass Index (BMI) ≤ 21 kg/m2, albuminemia ≤ 35 g/L)
- Obesity (BMI ≥ 30 kg/m2)
- Phosphatemia at the start of the dialysis < 1,5 mmol/L or > 3 mmol/L
- Secondary hyperparathyroidism with parathormone (PTH) ≥ 1000 pg/mL
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- Adynamic osteopathy (PTH ≤ 50 pg/mL)
- Hypoparathyroidism with a history of parathyroidectomy
- Hemoglobin ≤ 100 g/L
- Contraindication to heparin
- Temporary vascular access
- Contraindication to resonance magnetic spectroscopy (pacemaker or insulin pump, metallic valvular prosthesis, valvular prosthesis not compatible with resonance magnetic spectroscopy, dental appliance, intracerebral clip, claustrophobic subject).
- Simultaneous participation to another research protocol
- Patient not affiliated to a social security system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intracellular Phosphate and Adenosine Triphosphate (ATP) Concentration Evolution by Magnetic Resonance (MR) Spectroscopy in Patients During Hemodialysis
End-stage renal disease is associated with hyperphosphatemia due to a decrease of renal phosphate excretion. This hyperphosphatemia is associated with an increase of cardiovascular risk and mortality. Thus, three therapeutic options have been developed: dietary restriction, administration of phosphate binders and phosphorus clearance by hemodialysis (HD).
During a standard HD session, around 600 to 700mg phosphate is removed from the plasma, whereas it contains only 90 mg inorganic phosphate (Pi); 85% of phosphate is stored in bones and teeth in hydroxyapatite form, 14% is stored in the intracellular space (90% organic phosphate and 10% Pi), and 1% remains in the extracellular space.
Read more
Currently, the source of Pi cleared during HD remains to be determined. Phosphorus (31P) magnetic resonance spectroscopy allows reliable, dynamic and non-invasive measurements of phosphate intracellular concentration. The investigator's team recently published data obtained in anephric pigs, suggesting that phosphate intracellular concentration increases during a HD session. In parallel, we showed that ATP intracellular concentration decreased. These results suggest that the source of Pi cleared during HD could be located inside the cell.
In this study, investigators will measure intracellular phosphate and ATP concentrations and intracellular potential of hydrogen (pH) evolution during hemodialysis in 12 patients suffering from end-stage renal disease by MR spectroscopy.
If these results were confirmed in humans, it could explain, at least in part, HD intolerance in some patients and would lead to modify therapeutic approaches of hyperphosphatemia, for example, by modifying HD sessions time.
- Conditions
- End-Stage Renal Disease (ESRD)
- Being tested
- Phosphorus (31P) magnetic resonance spectroscopy, Hemodialysis
- Keywords
- ESRD, hemodialysis, phosphate, ATP, magnetic resonance spectroscopy
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phosphorus (31P) magnetic resonance spectroscopyDevice
Phosphorus MR spectroscopy realized using a 3-Tesla MR imaging system. A twenty-cm circular surface coil will be set to the 31P resonance frequency and placed over the leg muscle region to obtain spectroscopy acquisitions. 31P MR spectra will be acquired before, during (every 160 seconds), and 30 minutes after dialysis. 31P MR system data will be analyzed using jMRUI Software. Five different peaks will be analyzed: inorganic phosphate, phosphocreatine, α-, β-, and γ-ATP.
HemodialysisOther
Hemodialysis realized using a 5008 generator, a portable plant, a FX80 Dialyzer, a dialyzing solution with a standard electrolytes composition. The dialysis generator will be placed outside of the MRI examination room. The dialysis lines will pass through a wave guide to connect patients positioned on the bed of the MRI. A suitably trained nurse will proceed to the cannulation of the fistula, the connection of the catheter, and the monitoring of the clinical tolerance of the session.
| Study group | Role | What they receive |
|---|---|---|
| Patients suffering from ESRD treated by chronic hemodialysis | Experimental | Patients aged from 18 to 80 years old, suffering from ESRD, treated by chronic hemodialysis since at least 6 months and whose phosphatemia at the beginning of HD sessions ranged from 1.5 to 3 mmol/L. Phosphorus (31P) magnetic resonance spectroscopy will be performed in these patients during hemodialysis in order to measure intracellular phosphate and ATP concentrations and intracellular pH evolution during hemodialysis. Receives: Device: Phosphorus (31P) magnetic resonance spectroscopy; Other: Hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in phosphate intracellular concentration
Measurement of phosphate intracellular concentration evolution during a 4 hours hemodialysis (HD) session using phosphorus magnetic resonance spectroscopy.
Measured: Baseline, at start of HD, every 160 seconds during HD, at the end of HD and 30 minutes after HD
Secondary outcomes (4)
Change in ATP intracellular concentration
Measurement of ATP intracellular concentration evolution during a 4 hours HD session using phosphorus magnetic resonance spectroscopy.
Measured: Baseline, at start of HD, every 160 seconds during HD, at the end of HD and 30 minutes after HD
Change in intracellular pH
Measurement of intracellular pH evolution during a 4 hours HD session using phosphorus magnetic resonance spectroscopy. Intracellular pH will be calculated using the Henderson-Hasselbach formula: Ph = 6.75 + log (δ-3.27)/(5.69-δ), with δ being the difference (in parts per million) between inorganic phosphate (Pi) and phosphocreatine (PCr) resonance frequencies.
Measured: Baseline, at start of HD, every 160 seconds during HD, at the end of HD and 30 minutes after HD
Change in phosphatemia
Measurement of intracellular pH evolution during a 4 hours HD session using phosphorus magnetic resonance spectroscopy. Intracellular pH will be calculated using the Henderson-Hasselbach formula: Ph = 6.75 + log (δ-3.27)/(5.69-δ), with δ being the difference (in parts per million) between Pi (inorganic phosphate) and PCr (phosphocreatine) resonance frequencies.
Measured: At start of HD, every 15 minutes during first hour of HD, then every hour during HD, at the end of HD and 30 minutes after HD
Calcium balance
Calcium balance will be measured using the formula: (Cae - Cab)(Ve - UF)+(Cae * UF), where Cae is the calcium in the effluent, Cab is the calcium in the dialysis solution, Ve is the volume of effluent, and UF is the ultrafiltration.
Measured: At the end of a 4 hours HD session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start14 Jun 2017
- Primary completion29 Jul 2017
- Study completion29 Jul 2017
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 End-Stage Renal Disease (ESRD)Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent JUILLARD, MD, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119818
- Sponsor's protocol ID
- 69HCL17_0047
- Acronym
- CIPHEMO
- Status last verified
- Dec 2025
- First submitted
- 11 Apr 2017
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chazot G, Lemoine S, Kocevar G, Kalbacher E, Sappey-Marinier D, Rouviere O, Juillard L. Intracellular Phosphate and ATP Depletion Measured by Magnetic Resonance Spectroscopy in Patients Receiving Maintenance Hemodialysis. J Am Soc Nephrol. 2021 Jan;32(1):229-237. doi: 10.1681/ASN.2020050716. Epub 2020 Oct 22.
PubMed 33093193
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracellular Phosphate and Adenosine Triphosphate (ATP) Concentration Evolution by Magnetic Resonance (MR) Spectroscopy in Patients During Hemodialysis
- ClinicalTrials.gov ID
- NCT03119818
- Acronym / sponsor ID
- CIPHEMO / 69HCL17_0047
- Conditions
- End-Stage Renal Disease (ESRD)
- Keywords
- ESRD, hemodialysis, phosphate, ATP, magnetic resonance spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 29 Jul 2017 (actual)
- Study completion
- 29 Jul 2017 (actual)
- First posted
- 19 Apr 2017 (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.
End-stage renal disease is associated with hyperphosphatemia due to a decrease of renal phosphate excretion. This hyperphosphatemia is associated with an increase of cardiovascular risk and mortality. Thus, three therapeutic options have been developed: dietary restriction, administration of phosphate binders and phosphorus clearance by hemodialysis (HD).
During a standard HD session, around 600 to 700mg phosphate is removed from the plasma, whereas it contains only 90 mg inorganic phosphate (Pi); 85% of phosphate is stored in bones and teeth in hydroxyapatite form, 14% is stored in the intracellular space (90% organic phosphate and 10% Pi), and 1% remains in the extracellular space.
Currently, the source of Pi cleared during HD remains to be determined. Phosphorus (31P) magnetic resonance spectroscopy allows reliable, dynamic and non-invasive measurements of phosphate intracellular concentration. The investigator's team recently published data obtained in anephric pigs, suggesting that phosphate intracellular concentration increases during a HD session. In parallel, we showed that ATP intracellular concentration decreased. These results suggest that the source of Pi cleared during HD could be located inside the cell.
In this study, investigators will measure intracellular phosphate and ATP concentrations and intracellular potential of hydrogen (pH) evolution during hemodialysis in 12 patients suffering from end-stage renal disease by MR spectroscopy.
If these results were confirmed in humans, it could explain, at least in part, HD intolerance in some patients and would lead to modify therapeutic approaches of hyperphosphatemia, for example, by modifying HD sessions time.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients suffering from ESRD treated by chronic hemodialysis | Experimental | Device: Phosphorus (31P) magnetic resonance spectroscopy, Other: HemodialysisPatients aged from 18 to 80 years old, suffering from ESRD, treated by chronic hemodialysis since at least 6 months and whose phosphatemia at the beginning of HD sessions ranged from 1.5 to 3 mmol/L. Phosphorus (31P) magnetic resonance spectroscopy will be performed in these patients during hemodialysis in order to measure intracellular phosphate and ATP concentrations and intracellular pH evolution during hemodialysis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient suffering from end-stage renal disease, treated by chronic hemodialysis since at less 6 months
- Phosphatemia (at the start of the session) ≥ 1,5 mmol/L and ≤ 3 mmol/L
- written consent signed
Key exclusion criteria (14 listed)
- Major subject protected by law
- Prisoners or subjects who are involuntarily incarcerated
- Denutrition (weight loss ≥ 5 kg in one months/10 kg in 6 months, Body Mass Index (BMI) ≤ 21 kg/m2, albuminemia ≤ 35 g/L)
- Obesity (BMI ≥ 30 kg/m2)
- Phosphatemia at the start of the dialysis < 1,5 mmol/L or > 3 mmol/L
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 |
|---|---|---|
| Phosphorus (31P) magnetic resonance spectroscopyPhosphorus MR spectroscopy realized using a 3-Tesla MR imaging system. A twenty-cm circular surface coil will be set to the 31P resonance frequency and placed over the leg muscle region to obtain spectroscopy acquisitions. 31P MR spectra will be acquired before, during (every 160 seconds), and 30 minutes after dialysis. 31P MR system data will be analyzed using jMRUI Software. Five different peaks will be analyzed: inorganic phosphate, phosphocreatine, α-, β-, and γ-ATP. | Device | Patients suffering from ESRD treated by chronic hemodialysis |
| HemodialysisHemodialysis realized using a 5008 generator, a portable plant, a FX80 Dialyzer, a dialyzing solution with a standard electrolytes composition. The dialysis generator will be placed outside of the MRI examination room. The dialysis lines will pass through a wave guide to connect patients positioned on the bed of the MRI. A suitably trained nurse will proceed to the cannulation of the fistula, the connection of the catheter, and the monitoring of the clinical tolerance of the session. | Other | Patients suffering from ESRD treated by chronic hemodialysis |
Primary outcome
Change in phosphate intracellular concentration
Time frame: Baseline, at start of HD, every 160 seconds during HD, at the end of HD and 30 minutes after HD
Measurement of phosphate intracellular concentration evolution during a 4 hours hemodialysis (HD) session using phosphorus magnetic resonance spectroscopy.
4 secondary outcomes
Change in ATP intracellular concentration
Time frame: Baseline, at start of HD, every 160 seconds during HD, at the end of HD and 30 minutes after HD
Change in intracellular pH
Time frame: Baseline, at start of HD, every 160 seconds during HD, at the end of HD and 30 minutes after HD
Change in phosphatemia
Time frame: At start of HD, every 15 minutes during first hour of HD, then every hour during HD, at the end of HD and 30 minutes after HD
Calcium balance
Time frame: At the end of a 4 hours HD session
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 19 Dec 2025.
- Results publication: PubMed 33093193Chazot G, Lemoine S, Kocevar G, Kalbacher E, Sappey-Marinier D, Rouviere O, Juillard L. Intracellular Phosphate and ATP Depletion Measured by Magnetic Resonance Spectroscopy in Patients Receiving Maintenance Hemodialysis. J Am Soc Nephrol. 2021 Jan;32(1):229-237. doi: 10.1681/ASN.2020050716. Epub 2020 Oct 22.
- 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.
Laurent JUILLARD, MD, PhD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phosphorus (31P) magnetic resonance spectroscopy and Hemodialysis in people with End-Stage Renal Disease (ESRD), run by Hospices Civils de Lyon 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 3 inclusion and 14 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 19 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?
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?
Change in phosphate intracellular concentration (time frame: Baseline, at start of HD, every 160 seconds during HD, at the end of HD and 30 minutes after HD). 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 NCT03119818, 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 19 Dec 2025.