End Stage Renal DiseasePKMNCT01003223
Phosphate Kinetic Modeling
A study testing Computer algorithm management of hyperphosphatemia in people with End Stage Renal Disease and Hyperphosphatemia, run by Fresenius Medical Care North America at 1 site in United States.
Trial summary
Cardiovascular disease is a major cause of death in hemodialysis (HD) patients and is associated with widespread vascular calcification. There is a consensus that the chronic overload of calcium and phosphorus is a major factor in vascular calcification. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Hyperphosphatemia
- What is being tested?
- Computer algorithm management of hyperphosphatemia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Apr 2011
- 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
- Age ≥ 18 years
- Thrice weekly hemodialysis with a dialysate Ca++ concentration (CdiCa) of 2.25 or 2.5 mEq/L
- Stable CdiCa of either 2.25 or 2.5 mEq/L for ≥ 4 weeks
- Dialysis vintage ≥ 6 months
- Current serum phosphorus ("month -1") > 5.5 mg/dL and average serum phosphorus month -1 to -3 > 5.5 mg/dL and average serum phosphorus month -1 to -6 > 5.5 mg/dL
- Patients currently prescribed calcium acetate (PhosLo) mono-therapy , sevelamer monotherapy, or a combination therapy of PhosLo plus sevelamer for phosphate binding
- Fresenius Optiflux F 160, 180 or 200 dialyzer
Who cannot join
- Parathyroidectomy
- iPTH < 50 pg/mL
- Dialysate potassium prescription other than 2 or 3 mmol/L Corrected serum Ca++ < 7.5 mg/dL
Trial locations and contacts
1 site in 1 country.
United States1 site
Fresenius Medical Services
Waltham, Massachusetts, 02451
About this study
Cardiovascular disease is a major cause of death in hemodialysis (HD) patients and is associated with widespread vascular calcification. There is a consensus that the chronic overload of calcium and phosphorus is a major factor in vascular calcification. Hyperphosphatemia, deleterious in dialysis patients, is aggressively monitored and treated. Phosphate binders - designed to bind dietary phosphate and thus prevent its absorption, are ubiquitous in the dialysis patient population, and calcium-based phosphate binders are often first line therapy because they are tolerated well by the patients and low in cost. Phosphate Kinetic Modeling (PKM) is a tool to help physicians manage a hemodialysis patient's phosphate level. Once a subject consents to participate in the study, the subject's dietary phosphate intake will be estimated 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.Ongoing recommendations regarding oral phosphate binders dialysate calcium will be made using a computer generated algorithm.
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 dose of phosphate binder 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 index (PPI, 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. If the PPI exceeds 18, the report indicates it is likely the patient is not in compliance with respect to prescribed diet and/or binder. It is hoped that this information will be valuable to guide semiquantitative evaluations of diet P and binder intakes in patients difficult to manage.
Patients will be modeled on a monthly basis from pre- and post-dialytic Ca, P, PCR and other routine data readily available such as blood and dialysate flow rates, fluid removal etc. A monthly report will be generated for the physician and staff by Norma Ofsthun, PhD containing the analyses and recommendations for any changes in therapy.
- Conditions
- End Stage Renal Disease, Hyperphosphatemia
- Being tested
- Computer algorithm management of hyperphosphatemia
- Keywords
- phosphorus, dialysis, PhosLo, CKD stage V
- Medical subject headings
- Kidney Failure, Chronic, Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer algorithm management of hyperphosphatemiaOther
The PKM algorithm is a computer based program that calculates Phosphorus intake between dialysis, phosphorus reduction during dialysis treatment and daily oral phosphate binder intake compliance. Based on pre and post dialysis serum phosphorus levels, the algorithm makes recommendations in relation to dialysate calcium, oral phosphate binder use, and dietary counseling.
| Study group | Role | What they receive |
|---|---|---|
| PKM modeling with graphical report | Experimental | Not described Receives: Other: Computer algorithm management of hyperphosphatemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome variable is the change in serum phosphorus between a baseline period and the final 4 months of the study 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 posted28 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care North America
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003223
- Sponsor's protocol ID
- NEIRB PKM 09-207
- Acronym
- PKM
- Status last verified
- Nov 2010
- First submitted
- 27 Oct 2009
- 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
- ClinicalTrials.gov ID
- NCT01003223
- Acronym / sponsor ID
- PKM / NEIRB PKM 09-207
- Conditions
- End Stage Renal Disease, Hyperphosphatemia
- Keywords
- phosphorus, dialysis, PhosLo, CKD stage V
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Fresenius Medical Care North AmericaIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 28 Oct 2009 (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.
Cardiovascular disease is a major cause of death in hemodialysis (HD) patients and is associated with widespread vascular calcification. There is a consensus that the chronic overload of calcium and phosphorus is a major factor in vascular calcification. Hyperphosphatemia, deleterious in dialysis patients, is aggressively monitored and treated. Phosphate binders - designed to bind dietary phosphate and thus prevent its absorption, are ubiquitous in the dialysis patient population, and calcium-based phosphate binders are often first line therapy because they are tolerated well by the patients and low in cost. Phosphate Kinetic Modeling (PKM) is a tool to help physicians manage a hemodialysis patient's phosphate level. Once a subject consents to participate in the study, the subject's dietary phosphate intake will be estimated 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.Ongoing recommendations regarding oral phosphate binders dialysate calcium will be made using a computer generated algorithm.
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 dose of phosphate binder 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 index (PPI, 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. If the PPI exceeds 18, the report indicates it is likely the patient is not in compliance with respect to prescribed diet and/or binder. It is hoped that this information will be valuable to guide semiquantitative evaluations of diet P and binder intakes in patients difficult to manage.
Patients will be modeled on a monthly basis from pre- and post-dialytic Ca, P, PCR and other routine data readily available such as blood and dialysate flow rates, fluid removal etc. A monthly report will be generated for the physician and staff by Norma Ofsthun, PhD containing the analyses and recommendations for any changes in therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PKM modeling with graphical report | Experimental | Other: Computer algorithm management of hyperphosphatemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Thrice weekly hemodialysis with a dialysate Ca++ concentration (CdiCa) of 2.25 or 2.5 mEq/L
- Stable CdiCa of either 2.25 or 2.5 mEq/L for ≥ 4 weeks
- Dialysis vintage ≥ 6 months
- Current serum phosphorus ("month -1") > 5.5 mg/dL and average serum phosphorus month -1 to -3 > 5.5 mg/dL and average serum phosphorus month -1 to -6 > 5.5 mg/dL
Key exclusion criteria (3 listed)
- Parathyroidectomy
- iPTH < 50 pg/mL
- Dialysate potassium prescription other than 2 or 3 mmol/L Corrected serum Ca++ < 7.5 mg/dL
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 |
|---|---|---|
| Computer algorithm management of hyperphosphatemiaThe PKM algorithm is a computer based program that calculates Phosphorus intake between dialysis, phosphorus reduction during dialysis treatment and daily oral phosphate binder intake compliance. Based on pre and post dialysis serum phosphorus levels, the algorithm makes recommendations in relation to dialysate calcium, oral phosphate binder use, and dietary counseling. | Other | PKM modeling with graphical report |
Primary outcome
The primary outcome variable is the change in serum phosphorus between a baseline period and the final 4 months of the study period.
Time frame: 6 months
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer algorithm management of hyperphosphatemia in people with End Stage Renal Disease and Hyperphosphatemia, 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 7 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: 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.
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?
The primary outcome variable is the change in serum phosphorus between a baseline period and the final 4 months of the study period. (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.