Kidney FailurePhase 4NCT00294866
Effect of Paricalcitol on Markers of Inflammation in Hemodialysis Patients
A Phase 4 study testing Paricalcitol in people with Kidney Failure, run by Fresenius Medical Care North America at 6 sites in United States.
Trial summary
Studies have shown that patients with ESRD on hemodialysis have high levels of inflammatory markers which may contribute to the high rates of cardiovascular disease and mortality seen in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure
- What is being tested?
- Paricalcitol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2006to Jan 2008
- 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
- CKD and receiving hemodialysis for greater than or equal to 3 months
- Age greater than or equal to 18 years
- Medically stable
- AVF or PTFE dialysis access
- No acute inflammatory disease within 4 weeks prior to study
- On an average dose of 3 - 7 mcg of paricalcitol three times per week for 4 weeks prior to the study
Show all 10Show fewer
- Two consecutive iPTH of 150-400 (biPTH 75 - 200) =/- 30% one week apart
- Ca <10.2 mg/dL; PO4 <7.0
- Kt/V greater than or equal to 1.2
- On no other interventional drugs/devices in the past 30 days
Who cannot join
- Currently receiving dialysis using a venous catheter access
- Currently receiving high dose immunosuppressive therapy (greater than or equal to 10 mg prednisone)
- Pregnancy
- Hospitalization within the last 4 weeks. -
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Southwest Nephrology
Evergreen Park, Illinois, 60805
Nephrology Center
Kalamazoo, Michigan, 49007
Nephrology Associates, PC
Nashville, Tennessee, 37205
Delaware Valley Nephrology
Philadelphia, Pennsylvania, 19144
Tyler Nephrology Associates
Tyler, Texas, 75701
Nephrology Associates P.A.
West Orange, New Jersey, 07052
About this study
Official title: An Open Label, Multi-Center Study of the Effect of Paricalcitol on Markers of Inflammation in Patients With Stage 5 Chronic Kidney Disease on Hemodialysis.
Studies have shown that patients with ESRD on hemodialysis have high levels of inflammatory markers which may contribute to the high rates of cardiovascular disease and mortality seen in these patients. Vitamin D use in dialysis patients has been shown to have a survival benefit, with paricalcitol at advantage over calcitriol. Since there is some evidence for involvement of the vitamin D receptor in inflammation, this study is designed to look for an effect of paricalcitol on markers of inflammation in hemodialysis patients.
Read the detailed description
Patients with ESRD have a high incidence of acute phase inflammation. Studies have shown that C-reactive Protein (CRP) and interleukin-6 (IL-6) are excellent biomarkers for inflammation, and high levels are predictive of cardiovascular morbidity and mortality in this population. Both uremia and the dialysis process itself contribute to this inflammatory state. It is our hypothesis that paricalcitol therapy decreases the biomarkers of inflammation which may have implications for future studies of morbidity and mortality in this population.
- Conditions
- Kidney Failure
- Being tested
- Paricalcitol
- Keywords
- End Stage Renal Disease, Inflammation
- Medical subject headings
- Renal Insufficiency, Kidney Failure, Chronic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParicalcitolDrug
Patients randomized to either receive Paricalcitol or have it held. After 4 weeks they are switched to the opposite intervention.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Receive Paricalcitol Receives: Drug: Paricalcitol |
| B | No intervention | Paricalcitol on hold Receives: Drug: Paricalcitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome is a 20% change in IL-6 as a function of paricalcitol therapy.
Measured: 4 weeks
Secondary outcomes (2)
Secondary Outcome is a significant change in markers of inflammation to include:
Measured: 4 weeks
CRP,TNFα, IL-1β, IL-8, IL-10, IL-12p70, PTH, Ca/P
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2006 (estimated)
- Study startMar 2006
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney FailureStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care North America
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abbott
- Investigators
- Mark R Kaplan, M.D., Principal investigator, Fresenius Medical Care North America
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294866
- Sponsor's protocol ID
- 2005002
- Status last verified
- Apr 2010
- First submitted
- 17 Feb 2006
- Last updated
- 8 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multi-Center Study of the Effect of Paricalcitol on Markers of Inflammation in Patients With Stage 5 Chronic Kidney Disease on Hemodialysis.
- ClinicalTrials.gov ID
- NCT00294866
- Acronym / sponsor ID
- 2005002
- Conditions
- Kidney Failure
- Keywords
- End Stage Renal Disease, Inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Fresenius Medical Care North AmericaIndustry (pharma, biotech, devices)
- Collaborators
- Abbott
- Study start
- Mar 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 22 Feb 2006 (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.
Studies have shown that patients with ESRD on hemodialysis have high levels of inflammatory markers which may contribute to the high rates of cardiovascular disease and mortality seen in these patients. Vitamin D use in dialysis patients has been shown to have a survival benefit, with paricalcitol at advantage over calcitriol. Since there is some evidence for involvement of the vitamin D receptor in inflammation, this study is designed to look for an effect of paricalcitol on markers of inflammation in hemodialysis patients.
Detailed description
Patients with ESRD have a high incidence of acute phase inflammation. Studies have shown that C-reactive Protein (CRP) and interleukin-6 (IL-6) are excellent biomarkers for inflammation, and high levels are predictive of cardiovascular morbidity and mortality in this population. Both uremia and the dialysis process itself contribute to this inflammatory state. It is our hypothesis that paricalcitol therapy decreases the biomarkers of inflammation which may have implications for future studies of morbidity and mortality in this population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: ParicalcitolReceive Paricalcitol |
| B | No intervention | Drug: ParicalcitolParicalcitol on hold |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- CKD and receiving hemodialysis for greater than or equal to 3 months
- Age greater than or equal to 18 years
- Medically stable
- AVF or PTFE dialysis access
- No acute inflammatory disease within 4 weeks prior to study
Key exclusion criteria (4 listed)
- Currently receiving dialysis using a venous catheter access
- Currently receiving high dose immunosuppressive therapy (greater than or equal to 10 mg prednisone)
- Pregnancy
- Hospitalization within the last 4 weeks. -
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 |
|---|---|---|
| ParicalcitolPatients randomized to either receive Paricalcitol or have it held. After 4 weeks they are switched to the opposite intervention. | Drug | A, B |
Primary outcome
Primary Outcome is a 20% change in IL-6 as a function of paricalcitol therapy.
Time frame: 4 weeks
2 secondary outcomes
Secondary Outcome is a significant change in markers of inflammation to include:
Time frame: 4 weeks
CRP,TNFα, IL-1β, IL-8, IL-10, IL-12p70, PTH, Ca/P
Time frame: 4 weeks
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 8 Apr 2010.
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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.
Mark R Kaplan, M.D. principal investigator
Fresenius Medical Care North America
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paricalcitol in people with Kidney Failure, run by Fresenius Medical Care North America at 6 sites 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 10 inclusion and 4 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 8 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Primary Outcome is a 20% change in IL-6 as a function of paricalcitol therapy. (time frame: 4 weeks). 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 8 Apr 2010.