Effect of Paricalcitol on Markers of Inflammation in Hemodialysis Patients

Kidney Failure Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00294866
• Other study ID #: 2005002
• Status: Completed
• Phase: Phase 4
• First received: February 17, 2006
• Last updated: April 7, 2010
• Start date: March 2006
• Est. completion date: January 2008

Study information

• Verified date: April 2010
• Source: Fresenius Medical Care North America
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. -

Related Conditions & MeSH terms

• Inflammation
• Kidney Failure
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
United States	Southwest Nephrology	Evergreen Park	Illinois
United States	Nephrology Center	Kalamazoo	Michigan
United States	Nephrology Associates, PC	Nashville	Tennessee
United States	Delaware Valley Nephrology	Philadelphia	Pennsylvania
United States	Tyler Nephrology Associates	Tyler	Texas
United States	Nephrology Associates P.A.	West Orange	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Fresenius Medical Care North America	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome is a 20% change in IL-6 as a function of paricalcitol therapy.		4 weeks
Secondary	Secondary Outcome is a significant change in markers of inflammation to include:		4 weeks
Secondary	CRP,TNFa, IL-1ß, IL-8, IL-10, IL-12p70, PTH, Ca/P		4 weeks