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A Study to Evaluate the Safety and Efficacy of Paricalcitol Capsules in Reducing Serum Intact Parathyroid Hormone Levels in End Stage Renal Disease Subjects on Peritoneal Dialysis

Sponsor
Abbott (Industry)
Overall Status
Completed
CT.gov ID
NCT00646035
Collaborator
(none)
75
Enrollment
24
Locations
2
Arms
3.1
Patients Per Site

Study Details

Study Description

Brief Summary

To determine the safety and efficacy of paricalcitol capsules as compared to placebo for treatment of secondary hyperparathyroidism by decreasing serum intact parathyroid hormone levels in end stage renal disease subjects on peritoneal dialysis.

Condition or Disease Intervention/Treatment Phase
  • Drug: paricalcitol capsules
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase III, Prospective, Placebo-Controlled, Double-Blind, Randomized, Multi-Center Study to Evaluate the Safety and Efficacy of Paricalcitol Capsules in Reducing Serum Intact Parathyroid Hormone Levels in End Stage Renal Disease Subjects on Peritoneal Dialysis
Study Start Date :
Jan 1, 2002
Actual Primary Completion Date :
Nov 1, 2002

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: A

Drug: paricalcitol capsules
baseline iPTH/60
Other Names:
  • ABT-358
  • Zemplar
  • paricalcitol

    		•
    Placebo Comparator: B

    Drug: paricalcitol capsules
    baseline iPTH/60
    Other Names:
  • ABT-358
  • Zemplar
  • paricalcitol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The achievement of two consecutive greater than or equal to 30% decreases from baseline iPTH levels. [12 weeks]

    2. The incidence of clinically meaningful hypercalcemia and elevated Ca x P. [12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Subject is greater than or equal to 18 years.

    • Subject is diagnosed with ESRD and must be on continuous PD 7 days per week for at least 2 months prior to Screening Phase.

    • If female, subject is either not of childbearing potential or is of childbearing potential and practicing one of the recommended methods of birth control.

    • If female, subject must have a negative serum pregnancy test prior to treatment.

    • If female, subject is not breastfeeding.

    • Subject is undergoing full PD regimen and is expected to remain on this PD regimen for the duration of the study.

    • For those subjects who have been taking a phosphate binder prior to therapy, the subject has been on a stable type of phosphate binder at least 4 weeks prior to the Pre-Treatment Phase.

    • For entry into the Pretreatment Phase the subject must have: Calcium level less than or equal to 10.5 mg/dL and Ca x P level less than or equal to 65.

    • For entry into the Treatment Phase the subject must have: iPTH greater than or equal to 300 pg/mL, calcium level of 8.0 to 10.5 mg/dL, inclusive, and Ca x P less than or equal to 65.

    • Subject has voluntarily signed and dated an IRB approved informed consent.

    Exclusion Criteria:

    • Subject has history of an allergic reaction or significant sensitivity to drugs similar to the study drug

    • Subject has had active peritonitis within 1 month prior to screening phase.

    • Subject has had more than one episode of peritonitis within 4 months prior to screening phase.

    • Subject has received a partial parathyroidectomy within 1 year prior to screening phase.

    • Subject has had acute renal failure within 3 months of screening phase.

    • Subject has chronic gastrointestinal disease.

    • Subject has taken aluminum-containing phosphate binders for greater than 3 weeks in the last 3 months prior to the screening phase or will require these medications greater than 3 weeks in the study.

    • Subject has a current malignancy or clinically significant liver disease.

    • Subject has a history of drug or alcohol abuse within 6 months prior to screening phase.

    • Subject has evidence of poor compliance with diet, medication, or PD.

    • Subject has participated in any investigational drug or device study within 4 weeks prior to the treatment phase.

    • Subject is taking maintenance calcitonin, glucocorticoids, or other drugs that may affect calcium or bone metabolism, other than females on stable estrogen and/or progestin therapy.

    • For any reason, subject is considered by the investigator to be an unsuitable candidate to receive paricalcitol capsules.

    • Subject is known to be HIV positive.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Los Angeles California United States 90095
    2 Denver Colorado United States 80230
    3 Washington District of Columbia United States 20007
    4 Fort Myers Florida United States 33919
    5 Tampa Florida United States 33603
    6 Savannah Georgia United States 31405
    7 Evanston Illinois United States 60201
    8 Maywood Illinois United States 60153
    9 Indianapolis Indiana United States 46202
    10 New Orleans Louisiana United States 70112
    11 St. Louis Missouri United States 63110
    12 Las Vegas Nevada United States 89102
    13 Mineola New York United States 11501
    14 Cincinnati Ohio United States 45206
    15 Cincinnati Ohio United States 45220
    16 Cleveland Ohio United States 44195
    17 Portland Oregon United States 97210
    18 Charleston South Carolina United States 29425
    19 Memphis Tennessee United States 38105
    20 Nashville Tennessee United States 37205
    21 Houston Texas United States 77030
    22 Lubbock Texas United States 79430
    23 Krakow Poland 30-501
    24 Krakow Poland

    Sponsors and Collaborators

    • Abbott

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00646035
    Other Study ID Numbers:
    • 2001-015
    • R&D/02/655
    First Posted:
    Mar 28, 2008
    Last Update Posted:
    Mar 28, 2008
    Last Verified:
    Mar 1, 2008
    Additional relevant MeSH terms:
    Kidney Diseases
    Kidney Failure, Chronic
    Ergocalciferols

    Study Results

    No Results Posted as of Mar 28, 2008