End Stage Renal DiseasePhase 2NCT00686751
Immune Effects of Vitamin D in Hemodialysis Patients
A Phase 2 study testing paricalcitol in people with End Stage Renal Disease and Hemodialysis, run by Renal Research Institute at 3 sites in United States.
Trial summary
The purpose of this study to examine whether vitamin D can reduce the activation of the immune system during dialysis. When activated, the immune cells release certain substances, called cytokines, which can be measured from small blood samples. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- End Stage Renal Disease, Hemodialysis, Inflammatory Response
- What is being tested?
- paricalcitol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2004to Sep 2007
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient stable on chronic hemodialysis for more than 3 months.
- PTH level between 150 - 800 pg/ml.
- Ability to give informed consent.
- Serum calcium levels (corrected for albumin level of 4.0 g/dL) less than 10.5 mg/dL for the last three consecutive measurements.
- Serum Phosphorus levels between 2.5 and 7.0 mg/dL for the last three consecutive measurements.
- Ca x P-Product of less than 75 mg2/dL2 in the last three consecutive measurements.
Who cannot join
- Known active malignancy.
- Liver disease defined as serum aspartate aminotransferase, alanine aminotransferase, or gamma-glutamyltransferase levels more than 2 times the upper limits of normal.
- PTH levels between 150 pg/mL and 800 pg/mL.
- Hypercalcemia or hypercalcemic episodes within the last 4 weeks.
- Ca x P-Product more than 75 mg2/dL2 within the last 4 weeks.
- Any clinical significant infections which are or have been treated with antibiotics within 6 weeks prior to start of the study.
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- Chronic viral infection (HIV, Hepatitis B or C).
- Currently on immunosuppressive medication (steroids, cyclosporine, etc…).
- Hematocrit less than 30 %.
- History of blood disorders other than renal anemia.
- Age of less than 18 years or more than 75 years.
- Hypersensitivity to paricalcitol or any ingredient of the product.
- Parathyroidectomy.
- Participation in another study at the same time.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Irving Place Dialysis Center
New York, New York, 10003
Upper Manhattan Dialysis Center
New York, New York, 10025
Yorkville Dialysis Center
New York, New York, 10128
About this study
Official title: Immunomodulatory Effects of Vitamin D in Chronic Hemodialysis Patients
The purpose of this study to examine whether vitamin D can reduce the activation of the immune system during dialysis. When activated, the immune cells release certain substances, called cytokines, which can be measured from small blood samples. We want to study to what degree the immune system is activated during a regular dialysis treatment and whether the time point of vitamin D administration, either right before the start or right at the end of a dialysis treatment, has an impact on the activation of the immune system.
- Being tested
- paricalcitol
- Medical subject headings
- Kidney Failure, Chronic, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paricalcitolDrug
Dosage Form: Intravenous administration. Dosage: 0.01 micrograms/kilogram of body weight. Frequency: 2 HD treatments of each study week (depending on phase of study). Duration: 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | There is only one arm in this study. Each subject will be studied through 3 phases lasting a total of 4 weeks:
Phase 1: administration of study medication at the end of hemodialysis treatment.
Phase 2: no administration of study medication. Phase 3: administration of study medication at the beginning of hemodialysis. Receives: Drug: paricalcitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of pro- and anti-inflammatory cytokines and inflammatory markers
Measured: first and second HD treatments for the 4 weeks of the study
Secondary outcomes (2)
serum calcium level
Measured: 24 hours after termination of second HD treatment in week 3 of study
serum phosphate level
Measured: 24 hours after termination of second HD treatment in week 3 of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
- Study startDec 2004
- Primary completionSep 2007
- Study completionSep 2007
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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renal Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Investigators
- Nathan W Levin, MD, Principal investigator, Renal Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686751
- Sponsor's protocol ID
- 223-04
- Status last verified
- May 2009
- First submitted
- 27 May 2008
- Last updated
- 13 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomodulatory Effects of Vitamin D in Chronic Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00686751
- Acronym / sponsor ID
- 223-04
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Renal Research InstituteUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Dec 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 30 May 2008 (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 purpose of this study to examine whether vitamin D can reduce the activation of the immune system during dialysis. When activated, the immune cells release certain substances, called cytokines, which can be measured from small blood samples. We want to study to what degree the immune system is activated during a regular dialysis treatment and whether the time point of vitamin D administration, either right before the start or right at the end of a dialysis treatment, has an impact on the activation of the immune system.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: paricalcitolThere is only one arm in this study. Each subject will be studied through 3 phases lasting a total of 4 weeks: Phase 1: administration of study medication at the end of hemodialysis treatment. Phase 2: no administration of study medication. Phase 3: administration of study medication at the beginning of hemodialysis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient stable on chronic hemodialysis for more than 3 months.
- PTH level between 150 - 800 pg/ml.
- Ability to give informed consent.
- Serum calcium levels (corrected for albumin level of 4.0 g/dL) less than 10.5 mg/dL for the last three consecutive measurements.
- Serum Phosphorus levels between 2.5 and 7.0 mg/dL for the last three consecutive measurements.
Key exclusion criteria (14 listed)
- Known active malignancy.
- Liver disease defined as serum aspartate aminotransferase, alanine aminotransferase, or gamma-glutamyltransferase levels more than 2 times the upper limits of normal.
- PTH levels between 150 pg/mL and 800 pg/mL.
- Hypercalcemia or hypercalcemic episodes within the last 4 weeks.
- Ca x P-Product more than 75 mg2/dL2 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 |
|---|---|---|
| paricalcitolDosage Form: Intravenous administration. Dosage: 0.01 micrograms/kilogram of body weight. Frequency: 2 HD treatments of each study week (depending on phase of study). Duration: 4 weeks. | Drug | A |
Primary outcome
measurement of pro- and anti-inflammatory cytokines and inflammatory markers
Time frame: first and second HD treatments for the 4 weeks of the study
2 secondary outcomes
serum calcium level
Time frame: 24 hours after termination of second HD treatment in week 3 of study
serum phosphate level
Time frame: 24 hours after termination of second HD treatment in week 3 of study
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 13 May 2009.
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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.
Nathan W Levin, MD principal investigator
Renal Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing paricalcitol in people with End Stage Renal Disease and Hemodialysis, run by Renal Research Institute at 3 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 6 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 13 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
measurement of pro- and anti-inflammatory cytokines and inflammatory markers (time frame: first and second HD treatments for the 4 weeks of the study). 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 13 May 2009.