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

Abbott18 sites in 2 countries68 target enrollmentFebruary 2002

ConditionsRenal Insufficiency, Chronic

Drugsparicalcitol

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Renal Insufficiency, Chronic
Sponsor: Abbott
Enrollment: 68
Locations: 18
Primary Endpoint: The efficacy endpoint is achievement of two consecutive > or = 30% decreases from baseline iPTH levels.
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2002

End Date

TBD

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott

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

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