Chronic Kidney DiseaseNCT00428246
Study of Protective Effects of Paricalcitol on Inner Layer of Vessels and Its Protective Effect on Inflammation
A study testing paricalcitol in people with Chronic Kidney Disease and Endothelial Dysfunction, run by Indiana University at 1 site in United States.
Trial summary
The study is about possible protective effects of paricalcitol (Zemplar) upon inflammation, blood pressure and kidney function. Kidney Inflammation occurs when white blood cells become abnormally stimulated and accumulate in the kidney and cause damage to the kidney. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Endothelial Dysfunction, Inflammation
- What is being tested?
- paricalcitol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Jul 2007
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 with chronic kidney disease with estimated GFR of 30 mL/minute or more.
- Patients receiving stable dose of ACE inhibitor or Angiotensin receptor blockers for at least one month.
- Patients not currently hypertensive more than 180/110 mmHg by clinic blood pressure.
- Hemoglobulin A1C< 11%
Who cannot join
- Patients taking vitamin D analogs
- Calcium> 10 mg/dL
- Phosphorus>6 mg/dL
- Patients with anticipated need of dialysis in the next 6 weeks
- Patients unstable in the opinion of the investigator
- Patients who have emergent need for starting IV iron
Show all 11Show fewer
- Patients who will be started on statins within the next 6 weeks
- Patients currently taking PDE5 inhibitors
- Patients allergic to radiocontrast, Zemplar or who can not take nitroglycerin
- Patients known to be HIV positive
- Patients who can not give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Richard A. Rodebush VA Medical Center
Indianapolis, Indiana, 46202
About this study
Official title: Anti-Inflammatory and Endothelial Protectant Effects of Paricalcitol
The study is about possible protective effects of paricalcitol (Zemplar) upon inflammation, blood pressure and kidney function. Kidney Inflammation occurs when white blood cells become abnormally stimulated and accumulate in the kidney and cause damage to the kidney. The purpose of this study is to determine if paricalcitol helps improve kidney injury, blood pressure control and kidney function in patients with chronic kidney disease. The study will last about 7 weeks and involves about 8 visits to the medical center.
Read the detailed description
We hypothesize that use of paricalcitol in patients with chronic kidney disease will lead to improvement in oxidative stress, inflammation, endothelial function and subsequently ambulatory blood pressures and glomerular filtration rate. We will pursue our hypothesis by the three specific aims:
Aim 1: To compare oxidative stress markers in patients treated with paricalcitol before and after the study. Aim 2: To measure endothelial function by flow mediated dilation in patients with chronic kidney disease before and after paricalcitol. Aim 3: To measure actigraphy guided ambulatory blood pressure and GFR in the absence of changes in anti-hypertensive medications in patients with chronic kidney disease.
The study will be double blind randomized pilot trial in 24 patients with chronic kidney disease with 1:1:1 allocation to paricalcitol 1 microgram: paricalcitol 2 microgram: Placebo.
- Being tested
- paricalcitol, Placebo
- Keywords
- Chronic Kidney Disease, Endothelial dysfunction, Inflammation, Hypertension, paricalcitol, Blood pressure, Vitamin D, Glomerular filtration rate
- Medical subject headings
- Renal Insufficiency, Chronic, Inflammation, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paricalcitolDrug
Also called Zemplar
1 mcg or 2 mcg for 4 weeks.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 1 mcg paricalcitol Receives: Drug: paricalcitol |
| 2 | Active comparator | 2 mcg paricalcitol Receives: Drug: paricalcitol |
| 3 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-Inflammatory Effects of Paricalcitol
change in hsCRP level from baseline to 4 weeks
Measured: 6 weeks
Endothelial Protectant Effects of Paricalcitol
Measured: 6 weeks
Secondary outcomes (2)
Effect of Paricalcitol on Hypertension
Measured: 6 weeks
Effect of Paricalcitol on Kidney Function
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startNov 2006
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Investigators
- Rajiv Agarwal, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428246
- Sponsor's protocol ID
- 0510-04
- Status last verified
- Apr 2009
- First submitted
- 25 Jan 2007
- Last updated
- 3 Jun 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Alborzi P, Patel NA, Peterson C, Bills JE, Bekele DM, Bunaye Z, Light RP, Agarwal R. Paricalcitol reduces albuminuria and inflammation in chronic kidney disease: a randomized double-blind pilot trial. Hypertension. 2008 Aug;52(2):249-55. doi: 10.1161/HYPERTENSIONAHA.108.113159. Epub 2008 Jul 7.
PubMed 18606901
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Inflammatory and Endothelial Protectant Effects of Paricalcitol
- ClinicalTrials.gov ID
- NCT00428246
- Acronym / sponsor ID
- 0510-04
- Keywords
- Chronic Kidney Disease, Endothelial dysfunction, Inflammation, Hypertension, paricalcitol, Blood pressure, Vitamin D, Glomerular filtration rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Nov 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 29 Jan 2007 (estimated)
- Results
- Posted 3 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is about possible protective effects of paricalcitol (Zemplar) upon inflammation, blood pressure and kidney function. Kidney Inflammation occurs when white blood cells become abnormally stimulated and accumulate in the kidney and cause damage to the kidney. The purpose of this study is to determine if paricalcitol helps improve kidney injury, blood pressure control and kidney function in patients with chronic kidney disease. The study will last about 7 weeks and involves about 8 visits to the medical center.
Detailed description
We hypothesize that use of paricalcitol in patients with chronic kidney disease will lead to improvement in oxidative stress, inflammation, endothelial function and subsequently ambulatory blood pressures and glomerular filtration rate. We will pursue our hypothesis by the three specific aims:
Aim 1: To compare oxidative stress markers in patients treated with paricalcitol before and after the study. Aim 2: To measure endothelial function by flow mediated dilation in patients with chronic kidney disease before and after paricalcitol. Aim 3: To measure actigraphy guided ambulatory blood pressure and GFR in the absence of changes in anti-hypertensive medications in patients with chronic kidney disease.
The study will be double blind randomized pilot trial in 24 patients with chronic kidney disease with 1:1:1 allocation to paricalcitol 1 microgram: paricalcitol 2 microgram: Placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: paricalcitol1 mcg paricalcitol |
| 2 | Active comparator | Drug: paricalcitol2 mcg paricalcitol |
| 3 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with chronic kidney disease with estimated GFR of 30 mL/minute or more.
- Patients receiving stable dose of ACE inhibitor or Angiotensin receptor blockers for at least one month.
- Patients not currently hypertensive more than 180/110 mmHg by clinic blood pressure.
- Hemoglobulin A1C< 11%
Key exclusion criteria (11 listed)
- Patients taking vitamin D analogs
- Calcium> 10 mg/dL
- Phosphorus>6 mg/dL
- Patients with anticipated need of dialysis in the next 6 weeks
- Patients unstable in the opinion of the investigator
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 |
|---|---|---|
| paricalcitolAlso: Zemplar1 mcg or 2 mcg for 4 weeks. | Drug | 1, 2 |
| PlaceboPlacebo | Drug | 3 |
Primary outcome
Anti-Inflammatory Effects of Paricalcitol
Time frame: 6 weeks
change in hsCRP level from baseline to 4 weeks
Endothelial Protectant Effects of Paricalcitol
Time frame: 6 weeks
2 secondary outcomes
Effect of Paricalcitol on Hypertension
Time frame: 6 weeks
Effect of Paricalcitol on Kidney Function
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18606901Alborzi P, Patel NA, Peterson C, Bills JE, Bekele DM, Bunaye Z, Light RP, Agarwal R. Paricalcitol reduces albuminuria and inflammation in chronic kidney disease: a randomized double-blind pilot trial. Hypertension. 2008 Aug;52(2):249-55. doi: 10.1161/HYPERTENSIONAHA.108.113159. Epub 2008 Jul 7.
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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.
Rajiv Agarwal, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing paricalcitol in people with Chronic Kidney Disease and Endothelial Dysfunction, run by Indiana University 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 4 inclusion and 11 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 3 Jun 2009. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 3 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Anti-Inflammatory Effects of Paricalcitol (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00428246, which also lists 1 linked publication.
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 3 Jun 2009.