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Los Angeles, California 90073

  • Renal Insufficiency, Chronic

Purpose:

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.


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 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:

2001-021


NCT ID:

NCT00048516


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:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

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

Study Source:

Abbott


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

68


Enrollment Type:


Overall Contact Information

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

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: ClinicalTrials.gov

Date Processed: April 03, 2020

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