Clinical trial NCT00048438: 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: Orange
country: United States
facility: UCI Medical Center
state: California
city: Thornton
country: United States
facility: Western Nephrology
state: Colorado
city: Hudson
country: United States
facility: Outcomes Research International, Inc.
state: Florida
city: Miami
country: United States
facility: Nephrology Association of South Miami
state: Florida
city: Tampa
country: United States
facility: Tampa Bay Nephrology Associates
state: Florida
city: Chicago
country: United States
facility: Northwestern University Medical School
state: Illinois
city: Columbia
country: United States
facility: University of Missouri Health Sciences Center
state: Missouri
city: Kansas City
country: United States
facility: Arms, Dodge, Robinson, Wilber and Crouch
state: Missouri
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Las Vegas
country: United States
facility: NEA Research
state: Nevada
city: Great Neck
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Raleigh
country: United States
facility: Wake Nephrology Associates, PA
state: North Carolina
city: Cincinnati
country: United States
facility: Kidney and Hypertension Center
state: Ohio
city: Columbia
country: United States
facility: Dorn VA Hospital
state: South Carolina
city: Dallas
country: United States
facility: Dallas Nephrology Associates
state: Texas
city: Vancouver
country: United States
facility: The Vancouver Clinic, Inc., P.S.
state: Washington
city: Cracow
country: Poland
facility: Jagiellonian University
Study officials:
affiliation: Abbott
name: Laura Williams, M.D.
role: STUDY_DIRECTOR
References: