Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (Three Times Weekly)

Renal Insufficiency, Chronic Clinical Trial

Official title:

Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (Three Times Weekly)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00048451
• Other study ID #: 2001-020
• Status: Completed
• Phase: Phase 3
• First received: October 31, 2002
• Last updated: July 31, 2006
• Start date: February 2002

Study information

• Verified date: July 2006
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 mos. 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• paricalcitol

Locations

Country	Name	City	State
Poland	Wojskowy Instytut Medyczny	Warszawa
United States	Dialysis Clinic, Inc.	Cincinnati	Ohio
United States	Evanston Northwestern Healthcare	Evanston	Illinois
United States	Medisphere Medical Research Center	Evansville	Indiana
United States	University of Florida	Gainesville	Florida
United States	Kidney Associates	Houston	Texas
United States	Texas Tech University Health Science Center	Lubbock	Texas
United States	Miami Kidney Group	Miami	Florida
United States	Ochsner Clinic Chronic Dialysis	New Orleans	Louisiana
United States	The Rogosin Institute	New York	New York
United States	Biolab Research, LLC	Rockville	Maryland
United States	University of Texas Health Science Center	San Antonio	Texas
United States	California Institute of Renal Research	San Diego	California
United States	ICSL Clinical Studies	Sarasota	Florida
United States	Genesis Clinical Research Corporation	Tampa	Florida
United States	Nephrology Educational Services and Research, Inc.	Tarzana	California
United States	Tucson Therapeutic Research Institute, Inc.	Tucson	Arizona
United States	Phoenix Internal Medicine Associates	Waterbury	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

United States,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy endpoint is achievement of two consecutive > or = 30% decreases from baseline iPTH levels.