Chronic Kidney Disease Requiring Chronic DialysisRCTOIPNCT04600193
a Randomized Controlled Trial of the Intake of Organic and Inorganic Phosphate in Peritoneal Dialysis Patients
A study testing Diet containing organic phosphate and Diet containing inorganic phosphate in people with Chronic Kidney Disease Requiring Chronic Dialysis, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Hyperphosphatemia is a common problem among patientens suffering from chronic kidney disease. Hyperphosphatemia is associated with increased risk of cardiovascular diseases. One of the treatments are through the diet, where patients are instructed ind reducing their daily intake of phosphate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Requiring Chronic Dialysis
- What is being tested?
- Diet containing organic phosphate and Diet containing inorganic phosphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Mar 2021to 31 Dec 2021
- 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
- Patients > 18 years
- Competent
- The patient should be able to take a sample of p-fluid and urine by himself
- Chronic peritoneal dialysis
- Reads and understand danish
- Has been informed written and oraly about the study and signed informed consent
- P-phosphate koncentrations 0,7-2,0 .mol/l
- P - ioniset calcium 1,1-1,4 mmol/l
Who cannot join
- Pregnant or breast-feeding
- Terminal patients
- If the experience acute infections or other acute situations they will be excluded from the study
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Herlev Hospital
Herlev, 2730
Ditte Hansen, MD, +4538682056, ditte.hansen.04@regionh.dk
About this study
Hyperphosphatemia is a common problem among patientens suffering from chronic kidney disease. Hyperphosphatemia is associated with increased risk of cardiovascular diseases. One of the treatments are through the diet, where patients are instructed ind reducing their daily intake of phosphate. But since phosphate exists in both organic and inorganic forms in the diet, this leads to several problems. Informations of the bioavability and furthermore the effect of plasma koncentrations of phosphate are lacking for both forms of phosphate.
- Being tested
- Diet containing organic phosphate, Diet containing inorganic phosphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet containing organic phosphateOther
The patients will be receiving a 5 days diet containing organic phosphate
Diet containing inorganic phosphateOther
The patients will be receiving a 5 days diet containing inorganic phosphate
| Study group | Role | What they receive |
|---|---|---|
| Phosphate modified diet with organic phosphate | Experimental | Not described Receives: Other: Diet containing organic phosphate |
| Phosphate modified diet with inorganic phosphate | Experimental | Not described Receives: Other: Diet containing inorganic phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma levels of phosphate
Measured: six days
Secondary outcomes (9)
Changes in p-phosphate
Measured: six days
changes in p-calcium
Measured: six days
Changes in p-sodium
Measured: six days
Changes in p-potassium
Measured: six days
changes in p-PTH
Measured: six days
Changes in p-FGF23
Measured: six days
Changes in p-magnesium
Measured: six days
Koncentration of phosphate in peritoneal dialysis fluid
Measured: six days
Koncentration of phosphate in urine
Measured: six days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start17 Mar 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Requiring Chronic DialysisStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Stine Kristensen, Gita Krüger Mørch, Rizwan Butt, Ditte Hansen
- Responsible party
- Principal investigator, Jens Rikardt Andersen, University of Copenhagen
- Investigators
- Jens Rikardt Andersen, MD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600193
- Sponsor's protocol ID
- IOOAIOP
- Acronym
- RCTOIP
- Status last verified
- Mar 2021
- First submitted
- 19 Oct 2020
- Last updated
- 18 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Randomized Controlled Trial of the Intake of Organic and Inorganic Phosphate in Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT04600193
- Acronym / sponsor ID
- RCTOIP / IOOAIOP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Stine Kristensen, Gita Krüger Mørch, Rizwan Butt, Ditte Hansen
- Study start
- 17 Mar 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 23 Oct 2020 (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.
Hyperphosphatemia is a common problem among patientens suffering from chronic kidney disease. Hyperphosphatemia is associated with increased risk of cardiovascular diseases. One of the treatments are through the diet, where patients are instructed ind reducing their daily intake of phosphate. But since phosphate exists in both organic and inorganic forms in the diet, this leads to several problems. Informations of the bioavability and furthermore the effect of plasma koncentrations of phosphate are lacking for both forms of phosphate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phosphate modified diet with organic phosphate | Experimental | Other: Diet containing organic phosphate |
| Phosphate modified diet with inorganic phosphate | Experimental | Other: Diet containing inorganic phosphate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients > 18 years
- Competent
- The patient should be able to take a sample of p-fluid and urine by himself
- Chronic peritoneal dialysis
- Reads and understand danish
Key exclusion criteria (3 listed)
- Pregnant or breast-feeding
- Terminal patients
- If the experience acute infections or other acute situations they will be excluded from the study
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 |
|---|---|---|
| Diet containing organic phosphateThe patients will be receiving a 5 days diet containing organic phosphate | Other | Phosphate modified diet with organic phosphate |
| Diet containing inorganic phosphateThe patients will be receiving a 5 days diet containing inorganic phosphate | Other | Phosphate modified diet with inorganic phosphate |
Primary outcome
Plasma levels of phosphate
Time frame: six days
9 secondary outcomes
Changes in p-phosphate
Time frame: six days
changes in p-calcium
Time frame: six days
Changes in p-sodium
Time frame: six days
Changes in p-potassium
Time frame: six days
changes in p-PTH
Time frame: six days
Changes in p-FGF23
Time frame: six days
Changes in p-magnesium
Time frame: six days
Koncentration of phosphate in peritoneal dialysis fluid
Time frame: six days
Koncentration of phosphate in urine
Time frame: six days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
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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.
Jens Rikardt Andersen, MD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet containing organic phosphate and Diet containing inorganic phosphate in people with Chronic Kidney Disease Requiring Chronic Dialysis, run by University of Copenhagen at 1 site in Denmark.
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 8 inclusion and 3 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 18 Mar 2021. 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 Denmark. 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 Jens Rikardt Andersen, MD (+4523346652, jra@nexs.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma levels of phosphate (time frame: six days). 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 18 Mar 2021.