NCT00048516

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at below P25 for phase_3

Geographic Reach
2 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2002

Completed
Last Updated

August 2, 2006

Status Verified

July 1, 2006

First QC Date

November 1, 2002

Last Update Submit

July 31, 2006

Conditions

Renal Insufficiency, Chronic

Outcome Measures

Primary Outcomes (1)

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

Interventions

paricalcitol capsuleDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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\_
  • consecutive corrected serum calcium levels between 8.0-10.0 mg/dL
  • consecutive serum phosphorus levels of not more than 5.2 mg/mL

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

VA Greater Los Angeles Healthcare System, West Los Angeles

Los Angeles, California, 90073, United States

Location

Nephrology Associates Medical Group

Riverside, California, 92501, United States

Location

Kidney Center, Inc.

Simi Valley, California, 93065, United States

Location

Denver Nephrologists

Denver, Colorado, 80220, United States

Location

University of CO Health Sciences Center

Denver, Colorado, 80262, United States

Location

Dialysis PC

Des Moines, Iowa, 50309, United States

Location

Twin Cities Clinical Research

Arden Hills, Minnesota, 55126, United States

Location

Long Island College Hospital

Brooklyn, New York, 11201, United States

Location

Erie County Medical Center

Buffalo, New York, 14215, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Avera McKennan Research Institute

Sioux Falls, South Dakota, 57105, United States

Location

Nephrology Associates

Nashville, Tennessee, 37205, United States

Location

San Antonio Kidney Disease Research Center

San Antonio, Texas, 78219, United States

Location

Clinical Research Associates of Tidewater

Norfolk, Virginia, 23507, United States

Location

FHS Research Center

Tacoma, Washington, 98405, United States

Location

Wojewodzki Szpital Specjalistyczny AM w Bialymstoku

Bialymstoku, Poland

Location

Krakow Hospital

Krakow, Poland

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Laura Williams, M.D.

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 1, 2002

First Posted

November 4, 2002

Study Start

February 1, 2002

Last Updated

August 2, 2006

Record last verified: 2006-07

Locations

US(16)PL(2)