The objective of this study is to determine whether paricalcitol is safe and effective compared to placebo in reducing elevated serum PTH levels in patients with chronic kidney disease.

Condition	Treatment or Intervention	Phase
Renal Insufficiency, Chronic	Drug: paricalcitol capsule	Phase III

Further Study Details: 

Expected Total Enrollment:  68

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Under care of physician at least 2 months (for CKD)
• Not on active Vitamin D therapy for at least 4 weeks prior
• If female: -Not of childbearing potential, OR, -Practicing birth control -Not breastfeeding
• If taking phosphate binders, on a stable regimen at least 4 weeks prior
• For entry into Pretreatment Phase: -iPTH at least 120 pg/mL -GFR of 15-60 mL/min and no dialysis expected for at least 6 months
• For entry into Treatment Phase: -Average of 2 consecutive iPTH values of at least 150 pg/mL, taken at least 1 day apart (all values not less than 120 pg/mL_ -2 consecutive corrected serum calcium levels between 8.0-10.0 mg/dL -2 consecutive serum phosphorus levels of not more than 5.2 mg/mL

Exclusion Criteria:

• History of allergic reaction or sensitivity to similar drugs
• Acute Renal Failure within 12 weeks of study
• Chronic gastrointestinal disease
• Spot urine result demonstrating a urine-calcium-to-urine creatinine ratio of greater than 0,2, or a history of renal stones
• Taken aluminum-containing phosphate binders within last 12 weeks, or requires such medication for more than 3 weeks during study
• Current malignancy, or clinically significant liver disease
• Active granulomatous disease (TB, sarcoidosis, etc.)
• History of drug or alcohol abuse within 6 months prior
• Evidence of poor compliance with diet or medication
• Received any investigational drug or participated in any device trial within 30 days prior
• Taking maintenance calcitonin, bisphosphonates, or drugs that may affect calcium or bone metabolism (other than females on stable estrogen and/or progestin therapy)
• On glucocorticoids for a period of more than 14 days within the last 6 months
• HIV positive

California
      Nephrology Associates Medical Group, Riverside,  California,  92501,  United States
      VA Greater Los Angeles Healthcare System, West Los Angeles, Los Angeles,  California,  90073,  United States
      Kidney Center, Inc., Simi Valley,  California,  93065,  United States
Colorado
      Denver Nephrologists, Denver,  Colorado,  80220,  United States
      University of CO Health Sciences Center, Denver,  Colorado,  80262,  United States
Iowa
      Dialysis PC, Des Moines,  Iowa,  50309,  United States
Minnesota
      Twin Cities Clinical Research, Arden Hills,  Minnesota,  55126,  United States
New York
      Long Island College Hospital, Brooklyn,  New York,  11201,  United States
      Erie County Medical Center, Buffalo,  New York,  14215,  United States
Pennsylvania
      Temple University Hospital, Philadelphia,  Pennsylvania,  19140,  United States
South Carolina
      Medical University of South Carolina, Charleston,  South Carolina,  29425,  United States
South Dakota
      Avera McKennan Research Institute, Sioux Falls,  South Dakota,  57105,  United States
Tennessee
      Nephrology Associates, Nashville,  Tennessee,  37205,  United States
Texas
      San Antonio Kidney Disease Research Center, San Antonio,  Texas,  78219,  United States
Virginia
      Clinical Research Associates of Tidewater, Norfolk,  Virginia,  23507,  United States
Washington
      FHS Research Center, Tacoma,  Washington,  98405,  United States
Poland
      Krakow Hospital, Krakow,  Poland
      Wojewodzki Szpital Specjalistyczny AM w Bialymstoku, Bialymstoku,  Poland

Study ID Numbers:  2001-021
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 2002
ClinicalTrials.gov Identifier:  NCT00048516
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08