Clinical trial NCT00048451: Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (Three Times Weekly)
Official title: Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (Three Times Weekly)
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 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

Primary outcomes:
measure: The efficacy endpoint is achievement of two consecutive > or = 30% decreases from baseline iPTH levels.
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Tucson Therapeutic Research Institute, Inc.
state: Arizona
city: Pasadena
country: United States
state: California
city: San Diego
country: United States
facility: California Institute of Renal Research
state: California
city: Tarzana
country: United States
facility: Nephrology Educational Services and Research, Inc.
state: California
city: Waterbury
country: United States
facility: Phoenix Internal Medicine Associates
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: Miami Kidney Group
state: Florida
city: Sarasota
country: United States
facility: ICSL Clinical Studies
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research Corporation
state: Florida
city: Evanston
country: United States
facility: Evanston Northwestern Healthcare
state: Illinois
city: Evansville
country: United States
facility: Medisphere Medical Research Center
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Clinic Chronic Dialysis
state: Louisiana
city: Rockville
country: United States
facility: Biolab Research, LLC
state: Maryland
city: New York
country: United States
facility: The Rogosin Institute
state: New York
city: Cincinnati
country: United States
facility: Dialysis Clinic, Inc.
state: Ohio
city: Houston
country: United States
facility: Kidney Associates
state: Texas
city: Lubbock
country: United States
facility: Texas Tech University Health Science Center
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center
state: Texas
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny
Study officials:
affiliation: Abbott
name: Laura Williams, M.D.
role: STUDY_DIRECTOR
References: