Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (Daily Dosing)

Renal Insufficiency, Chronic Clinical Trial

Official title:

Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (Daily Dosing)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00048516
• Other study ID #: 2001-021
• Status: Completed
• Phase: Phase 3
• First received: November 1, 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 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

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 capsule

Locations

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

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 in iPTH levels