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Los Angeles, California 90073

  • Renal Insufficiency, Chronic


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.


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

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

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)

Overall Status:


Study Phase:

Phase 3



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:


Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Randomized, Endpoint Classification:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:

Overall Contact Information

Official Name:Laura Williams, M.D.
Study Director

Study Dates

Start Date:February 2002
Verification Date:July 2006
Last Changed Date:July 31, 2006
First Received Date:November 1, 2002

Study Outcomes

Outcome Type:Primary Outcome
Measure:The efficacy endpoint is achievement of two consecutive > or = 30% decreases from baseline in iPTH levels
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:paricalcitol capsule

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Abbott

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source:

Date Processed: April 03, 2020

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