Effect of Paricalcitol on Markers of Inflammation in Hemodialysis Patients

Study Overview
=================
Brief 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. 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.

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.

Conditions
-----------------
Kidney Failure

Intervention / Treatment
-----------------
* Drug: Paricalcitol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 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 Exclusion Criteria: 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. -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Receive Paricalcitol | Drug: Paricalcitol<br>* Patients randomized to either receive Paricalcitol or have it held. After 4 weeks they are switched to the opposite intervention.<br>|
| No Intervention: B<br>Paricalcitol on hold | Drug: Paricalcitol<br>* Patients randomized to either receive Paricalcitol or have it held. After 4 weeks they are switched to the opposite intervention.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome is a 20% change in IL-6 as a function of paricalcitol therapy. |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Outcome is a significant change in markers of inflammation to include: |  | 4 weeks | 
| CRP,TNFα, IL-1β, IL-8, IL-10, IL-12p70, PTH, Ca/P |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
End Stage Renal Disease, Inflammation