Clinical trial NCT00048516: Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (Daily Dosing)
Official title: Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (Daily Dosing)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Insufficiency, Chronic
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2002-11-04
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: The efficacy endpoint is achievement of two consecutive > or = 30% decreases from baseline in iPTH levels
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles
state: California
city: Riverside
country: United States
facility: Nephrology Associates Medical Group
state: California
city: Simi Valley
country: United States
facility: Kidney Center, Inc.
state: California
city: Denver
country: United States
facility: Denver Nephrologists
state: Colorado
city: Denver
country: United States
facility: University of CO Health Sciences Center
state: Colorado
city: Des Moines
country: United States
facility: Dialysis PC
state: Iowa
city: Arden Hills
country: United States
facility: Twin Cities Clinical Research
state: Minnesota
city: Brooklyn
country: United States
facility: Long Island College Hospital
state: New York
city: Buffalo
country: United States
facility: Erie County Medical Center
state: New York
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera McKennan Research Institute
state: South Dakota
city: Nashville
country: United States
facility: Nephrology Associates
state: Tennessee
city: San Antonio
country: United States
facility: San Antonio Kidney Disease Research Center
state: Texas
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater
state: Virginia
city: Tacoma
country: United States
facility: FHS Research Center
state: Washington
city: Bialymstoku
country: Poland
facility: Wojewodzki Szpital Specjalistyczny AM w Bialymstoku
city: Krakow
country: Poland
facility: Krakow Hospital
Study officials:
affiliation: Abbott
name: Laura Williams, M.D.
role: STUDY_DIRECTOR
References: