HyperphosphatemiaPhase 4PKM2NCT01252771
Phosphate Kinetic Modeling 2
A Phase 4 study testing PKM Algorithm in people with Hyperphosphatemia and ESRD, run by Fresenius Medical Care North America at 1 site in United States.
Trial summary
The study aims to investigate the concept of computer based Phosphate Kinetic Modeling (PKM) in the hemodialysis patient population. This computerized algorithm model was developed as a tool to aid physicians in controlling a hemodialysis patient's phosphate level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperphosphatemia, ESRD
- What is being tested?
- PKM Algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Dec 2011
- Phase
- Phase 4
- 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
- Subject is capable of giving informed consent.
- Age > 18 years
- Thrice weekly hemodialysis with a dialysate Ca++ concentration (CdiCa) of 2.0, 2.25 or 2.5 mEq/L
- Stable CdiCa of either 2.0, 2.25 or 2.5 mEq/L for ≥ 4 weeks
- Dialysis vintage ≥ 3 months
- Three-month average P > 5.5 mg/dL AND 2 of 3 monthly average P >=5.8 mg/dL
- Patients currently prescribed calcium acetate (PhosLo) mono-therapy , sevelamer monotherapy, or a combination therapy of PhosLo plus sevelamer for phosphate binding with willingness of physician to switch to PhosLo monotherapy
- Fresenius Optiflux F 160, 180 or 200 dialyzer
Who cannot join
- Any laboratory abnormality, medical condition or psychiatric disorder which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements
- Known pregnancy
- Parathyroidectomy
- iPTH < 50 pg/mL
- Hospitalization in past 30 days
- Dialysate potassium prescription other than 2 or 3 mmol/L
- Serum Ca++ < 7.5 mg/dL
- Current vitamin D therapy using calcitriol
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to investigate the concept of computer based Phosphate Kinetic Modeling (PKM) in the hemodialysis patient population. This computerized algorithm model was developed as a tool to aid physicians in controlling a hemodialysis patient's phosphate level. Once a subject consents to participate in the study, the subject's dietary phosphate intake will be estimated by the modeling program and the appropriate dose of the phosphate binder calcium acetate (PhosLo) will be recommended accordingly. If necessary, the Ca++ concentration of the dialysate will be changed to remove any excess calcium absorbed as the result of an increase in the PhosLo prescription to control phosphorus.
Read the detailed description
PKM consists of a set of validated and computerized algorithms to perform the following steps:
- Calculate calcium (Ca) and phosphorus (P) intake and absorption in individual patients as a function of the prescribed doses of Vitamin D analogues, protein catabolic rate (PCR) and dietary and binder Ca intakes.
- Calculate P removal between dialyses by P binders and P and Ca removal during dialysis from kinetic analysis of total P and Ca transport during dialysis based on dialyzer P and Ca transport coefficients and the levels of dialysate Ca and serum Ca and P.
- Thus from analysis of intake, absorption and removal the program can calculate net Ca and P balance in modeled patients.
- Calculate the daily dose of phosphate binder (PhosLo) required to reduce the serum P to normal in patients with hyperphosphatemia.
- Calculate the dialysate Ca required to achieve zero calcium balance over complete dialysis cycles - the interdialytic interval and immediately succeeding dialytic interval.
- The program also computes a Phosphorus-Protein ratio (PPR, the total P removed divided by PCR, mg/gm/day) which provides a quantitative index of compliance with prescribed dietary P restriction and/or the prescribed dose of binders. It is hoped that this information will be valuable to guide semi-quantitative evaluations of diet P and binder intakes in patients difficult to manage. Study subjects will bring their PhosLo pill bottles to treatments weekly. At this time the subject's dietitian will determine and record the remaining pills. The comparison of pills taken versus pilled prescribed will be performed with any data available. While weekly counts are desirable for providing more information about the consistency of a patient's compliance, a minimum of monthly counts will be sufficient. This will be done to validate the PPR range needed to accurately identify compliance with PhosLo regimen. Patients will also be instructed to bring all empty PhosLo bottles to site dietitian. The site dietitian will record pill count data in a form for each patient. The updated version of the PKM algorithm also includes computation of the dose of vitamin D analogues and cinacalcet (Sensipar). This modification of the PKM algorithm may help to better achieve neutral calcium balance, because the intestinal calcium absorption heavily depends on vitamin D levels. The computation of cinacalcet aids the control of parathyroid hormone (PTH) levels within the target range.
- Conditions
- Hyperphosphatemia, ESRD
- Being tested
- PKM Algorithm
- Keywords
- phosphorus, dialysis, PhosLo
- Medical subject headings
- Hyperphosphatemia, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PKM AlgorithmOther
The subject's serum calcium and phosphorus values will be input into PKM in order to determine the required PhosLo prescription. The prescription is determined as the number of gelcaps per day that must be taken by the subject.
If PKM determines the number of PhosLo gelcaps per day to be greater than or equal to the subject's current prescription, then PKM will calculate the current Ca++ and phosphate balance. Furthermore, the PKM algorithm will determine the additional number of PhosLo gelcaps needed to achieve neutral phosphate (P) balance with serum P reduced to 5.5 mg/dL.
The PKM algorithm also calculates the total P intake between dialyses and along with ePCR also calculates a Phosphorus/Protein Ratio (PPR). This ratio ranges from 8 to 14 in dialysis patients following a renal diet.
| Study group | Role | What they receive |
|---|---|---|
| PKM report and algorithm | Experimental | Phosphate kinetic modeling was performed and displayed in graphical form laboratory results and an estimated phophorus protein ratio Receives: Other: PKM Algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in serum phosphorus
The primary outcome variable is the change in serum phosphorus between a baseline period and the latest value of the intervention period.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperphosphatemiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care North America
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Renal Research Institute
- Responsible party
- Sponsor
- Investigators
- Peter Kotanko, MD, Principal investigator, Renal Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252771
- Sponsor's protocol ID
- 10-188
- Acronym
- PKM2
- Status last verified
- Jun 2011
- First submitted
- 1 Dec 2010
- Last updated
- 18 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phosphate Kinetic Modeling 2
- ClinicalTrials.gov ID
- NCT01252771
- Acronym / sponsor ID
- PKM2 / 10-188
- Conditions
- Hyperphosphatemia, ESRD
- Keywords
- phosphorus, dialysis, PhosLo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Fresenius Medical Care North AmericaIndustry (pharma, biotech, devices)
- Collaborators
- Renal Research Institute
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 3 Dec 2010 (estimated)
- 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.
The study aims to investigate the concept of computer based Phosphate Kinetic Modeling (PKM) in the hemodialysis patient population. This computerized algorithm model was developed as a tool to aid physicians in controlling a hemodialysis patient's phosphate level. Once a subject consents to participate in the study, the subject's dietary phosphate intake will be estimated by the modeling program and the appropriate dose of the phosphate binder calcium acetate (PhosLo) will be recommended accordingly. If necessary, the Ca++ concentration of the dialysate will be changed to remove any excess calcium absorbed as the result of an increase in the PhosLo prescription to control phosphorus.
Detailed description
PKM consists of a set of validated and computerized algorithms to perform the following steps:
- Calculate calcium (Ca) and phosphorus (P) intake and absorption in individual patients as a function of the prescribed doses of Vitamin D analogues, protein catabolic rate (PCR) and dietary and binder Ca intakes.
- Calculate P removal between dialyses by P binders and P and Ca removal during dialysis from kinetic analysis of total P and Ca transport during dialysis based on dialyzer P and Ca transport coefficients and the levels of dialysate Ca and serum Ca and P.
- Thus from analysis of intake, absorption and removal the program can calculate net Ca and P balance in modeled patients.
- Calculate the daily dose of phosphate binder (PhosLo) required to reduce the serum P to normal in patients with hyperphosphatemia.
- Calculate the dialysate Ca required to achieve zero calcium balance over complete dialysis cycles - the interdialytic interval and immediately succeeding dialytic interval.
- The program also computes a Phosphorus-Protein ratio (PPR, the total P removed divided by PCR, mg/gm/day) which provides a quantitative index of compliance with prescribed dietary P restriction and/or the prescribed dose of binders. It is hoped that this information will be valuable to guide semi-quantitative evaluations of diet P and binder intakes in patients difficult to manage. Study subjects will bring their PhosLo pill bottles to treatments weekly. At this time the subject's dietitian will determine and record the remaining pills. The comparison of pills taken versus pilled prescribed will be performed with any data available. While weekly counts are desirable for providing more information about the consistency of a patient's compliance, a minimum of monthly counts will be sufficient. This will be done to validate the PPR range needed to accurately identify compliance with PhosLo regimen. Patients will also be instructed to bring all empty PhosLo bottles to site dietitian. The site dietitian will record pill count data in a form for each patient. The updated version of the PKM algorithm also includes computation of the dose of vitamin D analogues and cinacalcet (Sensipar). This modification of the PKM algorithm may help to better achieve neutral calcium balance, because the intestinal calcium absorption heavily depends on vitamin D levels. The computation of cinacalcet aids the control of parathyroid hormone (PTH) levels within the target range.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PKM report and algorithm | Experimental | Other: PKM AlgorithmPhosphate kinetic modeling was performed and displayed in graphical form laboratory results and an estimated phophorus protein ratio |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is capable of giving informed consent.
- Age > 18 years
- Thrice weekly hemodialysis with a dialysate Ca++ concentration (CdiCa) of 2.0, 2.25 or 2.5 mEq/L
- Stable CdiCa of either 2.0, 2.25 or 2.5 mEq/L for ≥ 4 weeks
- Dialysis vintage ≥ 3 months
Key exclusion criteria (8 listed)
- Any laboratory abnormality, medical condition or psychiatric disorder which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements
- Known pregnancy
- Parathyroidectomy
- iPTH < 50 pg/mL
- Hospitalization in past 30 days
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 |
|---|---|---|
| PKM AlgorithmThe subject's serum calcium and phosphorus values will be input into PKM in order to determine the required PhosLo prescription. The prescription is determined as the number of gelcaps per day that must be taken by the subject. If PKM determines the number of PhosLo gelcaps per day to be greater than or equal to the subject's current prescription, then PKM will calculate the current Ca++ and phosphate balance. Furthermore, the PKM algorithm will determine the additional number of PhosLo gelcaps needed to achieve neutral phosphate (P) balance with serum P reduced to 5.5 mg/dL. The PKM algorithm also calculates the total P intake between dialyses and along with ePCR also calculates a Phosphorus/Protein Ratio (PPR). This ratio ranges from 8 to 14 in dialysis patients following a renal diet. | Other | PKM report and algorithm |
Primary outcome
change in serum phosphorus
Time frame: 6 months
The primary outcome variable is the change in serum phosphorus between a baseline period and the latest value of the intervention period.
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 18 Aug 2014.
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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.
Peter Kotanko, MD principal investigator
Renal Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PKM Algorithm in people with Hyperphosphatemia and ESRD, run by Fresenius Medical Care North America at 1 site in United States.
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 8 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 18 Aug 2014. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 serum phosphorus (time frame: 6 months). 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 Aug 2014.