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

Tracking Information

First Received Date ^ICMJE

October 31, 2002

Last Updated Date

August 10, 2006

Start Date ^ICMJE

February 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The efficacy endpoint is achievement of two consecutive > or = 30% decreases from baseline iPTH levels.

Original Primary Outcome Measures ^ICMJE

The efficacy endpoint is achievement of two consecutive 230% decreases from baseline iPTH levels.

Change History

Complete list of historical versions of study NCT00048438 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Renal Insufficiency, Chronic

Intervention ^ICMJE

Drug: paricalcitol

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Poland

Administrative Information

NCT ID ^ICMJE

NCT00048438

Responsible Party

Study ID Numbers ^ICMJE

2001-019

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Laura Williams, M.D.

Abbott

Information Provided By

Abbott

Verification Date

August 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP