Effect of Paricalcitol on Markers of Inflammation in Hemodialysis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-01-31

Brief Summary

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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.

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Detailed Description

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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

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Kidney Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A

Receive Paricalcitol

Group Type ACTIVE_COMPARATOR

Paricalcitol

Intervention Type DRUG

Patients randomized to either receive Paricalcitol or have it held. After 4 weeks they are switched to the opposite intervention.

B

Paricalcitol on hold

Group Type NO_INTERVENTION

Paricalcitol

Intervention Type DRUG

Patients randomized to either receive Paricalcitol or have it held. After 4 weeks they are switched to the opposite intervention.

Interventions

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Paricalcitol

Patients randomized to either receive Paricalcitol or have it held. After 4 weeks they are switched to the opposite intervention.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. CKD and receiving hemodialysis for greater than or equal to 3 months
2. Age greater than or equal to 18 years
3. Medically stable
4. AVF or PTFE dialysis access
5. No acute inflammatory disease within 4 weeks prior to study
6. On an average dose of 3 - 7 mcg of paricalcitol three times per week for 4 weeks prior to the study
7. Two consecutive iPTH of 150-400 (biPTH 75 - 200) =/- 30% one week apart
8. Ca \<10.2 mg/dL; PO4 \<7.0
9. Kt/V greater than or equal to 1.2
10. On no other interventional drugs/devices in the past 30 days

Exclusion Criteria

1. Currently receiving dialysis using a venous catheter access
2. Currently receiving high dose immunosuppressive therapy (greater than or equal to 10 mg prednisone)
3. Pregnancy
4. Hospitalization within the last 4 weeks. -

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No