Chronic Kidney DiseaseNCT00915876

Vascular Reactivity in Chronic Kidney Disease (CKD) Patients Receiving Paricalcitol Versus Placebo

A study testing Paricalcitol in people with Chronic Kidney Disease, run by Amy Barton Pai at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Disease
What is being tested?: Paricalcitol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 41 participants
Where: 1 siteUnited States
Study dates: Mar 2009to Mar 2011
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

Males or females ≥ 18 years of age at the start of screening
CKD with eGFR 15-60 mL/min/1.73m2 by MDRD
Not expected to start dialysis for 4 months
Serum intact PTH 70-200 pg/mL during screening period
On stable ACEI/ARB regimen for 30 days prior to screening

Who cannot join

History of any of the following diseases:
congestive heart failure
MI within the last 6 months
history of cerebrovascular accident
significant valvular disease
malignancy

Show all 12Show fewer

Currently taking any vitamin D products
Mean systolic blood pressure values > 190 or diastolic blood pressure values > 100 mm/Hg during the preceding 30 day period prior to screening
Currently being titrated on therapy with an angiotensin converting enzyme inhibitor or angiotensin receptor blocker
Two consecutive serum calcium values greater than 10.2 mg/dL or Ca x P > 55 mg2/dL2
Currently receiving erythropoiesis stimulating agent or intravenous iron therapy
Pregnant or breastfeeding

Trial locations and contacts

1 site in 1 country.

United States1 site

Albany Medical Center South Clinical Campus
Albany, New York, 12208

Other trials in United States

About this study

Official title: Effects of 19-nor-1α-dihydroxyvitamin D2 (Paricalcitol) Versus Placebo on Oxidative Stress and Vascular Reactivity in CKD Patients

This research is studying how Vitamin D may affect blood vessels reaction to stress and blood levels of substances that may increase blockages in the blood vessels in chronic kidney disease (CKD) patients. Blood vessel health is worsened in CKD and some studies have shown that Vitamin D improves blood vessel health. The type of Vitamin D being used in this study (paricalcitol) is Food and Drug Administration (FDA) approved to treat high parathyroid hormone levels. The purpose of this study is to find out if paricalcitol has other benefits beyond its ability to lower parathyroid hormone levels such as improving the blood vessels reaction to stress and decreasing blood levels of substances that may increase blockages in the blood vessels.

Conditions: Chronic Kidney Disease
Being tested: Paricalcitol, Placebo
Keywords: chronic kidney disease, Vitamin D
Medical subject headings: Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ParicalcitolDrug
paricalcitol 1 mcg QD x 8 weeks
PlaceboDrug
Placebo for Paricalcitol 1 mcg QD x 8 weeks

Study groups in NCT00915876
Study group	Role	What they receive
Paricalcitol	Active comparator	Not described Receives: Drug: Paricalcitol
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56
Values of ICAM-1 (intracellular adhesion molecule) a measure of vascular reactivity, at three time points: baseline, day 28, and day 56
Measured: Day 28 and Day 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Mar 2011

First posted8 Jun 2009 (estimated)
Study startMar 2009
Primary completionMar 2011
Study completionMar 2011

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.
Other trials for Chronic Kidney 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
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00915876
Sponsor's protocol ID: Paricalcitol-AMC2443
Status last verified: Oct 2016
First submitted: 5 Jun 2009
Last updated: 2 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of 19-nor-1α-dihydroxyvitamin D2 (Paricalcitol) Versus Placebo on Oxidative Stress and Vascular Reactivity in CKD Patients
ClinicalTrials.gov ID: NCT00915876
Acronym / sponsor ID: Paricalcitol-AMC2443
Conditions: Chronic Kidney Disease
Keywords: chronic kidney disease, Vitamin D
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Amy Barton PaiUniversity, hospital or other
Collaborators: Albany College of Pharmacy and Health Sciences
Study start: Mar 2009
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 8 Jun 2009 (estimated)
Results: Posted 2 Dec 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Paricalcitol	Active comparator	Drug: Paricalcitol
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Males or females ≥ 18 years of age at the start of screening
CKD with eGFR 15-60 mL/min/1.73m2 by MDRD
Not expected to start dialysis for 4 months
Serum intact PTH 70-200 pg/mL during screening period
On stable ACEI/ARB regimen for 30 days prior to screening

Key exclusion criteria (12 listed)

History of any of the following diseases:
Currently taking any vitamin D products
Mean systolic blood pressure values > 190 or diastolic blood pressure values > 100 mm/Hg during the preceding 30 day period prior to screening
Currently being titrated on therapy with an angiotensin converting enzyme inhibitor or angiotensin receptor blocker
Two consecutive serum calcium values greater than 10.2 mg/dL or Ca x P > 55 mg2/dL2

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
Paricalcitolparicalcitol 1 mcg QD x 8 weeks	Drug	Paricalcitol
PlaceboPlacebo for Paricalcitol 1 mcg QD x 8 weeks	Drug	Placebo

Primary outcome

Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56
Time frame: Day 28 and Day 56
Values of ICAM-1 (intracellular adhesion molecule) a measure of vascular reactivity, at three time points: baseline, day 28, and day 56

Results and safety

Results posted to the registry on 2 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Paricalcitol	20	20
Placebo	21	20

Primary outcome: Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56

Time frame: Day 28 and Day 56. Mean (Standard Deviation). Unit: nanogram/ml

Measure	Placebo n = 20	Paricalcitol n = 20
Baseline	707 (504)	701 (603)
Day 28	679 (557)	627 (570)
Day 56	590 (458)	477 (382)

Placebo vs Paricalcitol: p >0.05, ANOVA

Adverse events

Time frame: TENTATIVE: 7 weeks of intervention and 30 days of followup, totalling up to 12 weeks per person. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 21 (0%)	1 of 21 (4.8%)	Not reported
Paricalcitol	0 of 20 (0%)	0 of 20 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Not yet recruiting
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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.

Amy Pai, Pharm.D. principal investigator

Albany College of Pharmacy and Health Sciences

Amy Pai, PharmD principal investigator

Albany College of Pharmacy and Health Sciences

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, run by Amy Barton Pai 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 5 inclusion and 12 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 2 Dec 2016. 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 2 Dec 2016). 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?

Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56 (time frame: Day 28 and Day 56). 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 NCT00915876.

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 2 Dec 2016.