Effect of Paricalcitol on Markers of Inflammation in Hemodialysis Patients

NCT00294866 | Completed Phase 4

• 1 other identifier: 2005002
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 6

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.

Conditions

Kidney Failure

Keywords

End Stage Renal Disease; Inflammation

Outcome Measures

Primary Outcomes (1)

• Primary Outcome is a 20% change in IL-6 as a function of paricalcitol therapy.

  4 weeks

Secondary Outcomes (2)

• 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

Study Arms (2)

A

ACTIVE COMPARATOR

Receive Paricalcitol

Drug: Paricalcitol

B

NO INTERVENTION

Paricalcitol on hold

Drug: Paricalcitol

Interventions

Paricalcitol DRUG

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

A; B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Fresenius Medical Care North America: lead
• Abbott: collaborator

Study Sites (6)

Southwest Nephrology

Evergreen Park, Illinois, 60805, United States

Location

Nephrology Center

Kalamazoo, Michigan, 49007, United States

Location

Nephrology Associates P.A.

West Orange, New Jersey, 07052, United States

Location

Delaware Valley Nephrology

Philadelphia, Pennsylvania, 19144, United States

Location

Nephrology Associates, PC

Nashville, Tennessee, 37205, United States

Location

Tyler Nephrology Associates

Tyler, Texas, 75701, United States

Location

MeSH Terms

Conditions

Renal Insufficiency; Kidney Failure, Chronic; Inflammation

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark R Kaplan, M.D.

  Fresenius Medical Care North America

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 17, 2006
• First Posted: February 22, 2006
• Study Start: March 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: April 8, 2010

Record last verified: 2010-04

Locations

US (6)