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Zemplar® Capsule in Reducing Serum Intact Parathyroid Hormone Levels in Chronic Kidney Disease Stage 5 Subjects on Hemodialysis or Peritoneal Dialysis

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ClinicalTrials.gov Identifier: NCT00091975
Recruitment Status : Completed
First Posted : September 22, 2004
Last Update Posted : January 19, 2011
Sponsor:
Information provided by:
Abbott

Study Description
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Brief Summary:
The objective of this study is to determine the safety and efficacy of Zemplar® Capsule versus placebo, in decreasing elevated intact parathyroid hormone levels in chronic kidney disease stage 5 subjects with secondary hyperparathyroidism on hemodialysis or peritoneal dialysis, while using the revised dose titration scheme.

Condition or disease Intervention/treatment Phase
Kidney Disease Drug: Zemplar Capsule Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multi-Center Study to Evaluate the Safety and Efficacy of Zemplar® Capsule in Reducing Serum Intact Parathyroid Hormone Levels in Chronic Kidney Disease Stage 5 Subjects on Hemodialysis or Peritoneal Dialysis
Study Start Date : August 2004

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. The efficacy endpoint is achievement of two consecutive > or = 30% decreases from baseline in iPTH levels

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Subject was at least 18 years of age, diagnosed with CKD Stage 5 and undergoing HD or PD.
  • If female, subject was either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or was of childbearing potential and practicing 1 of the protocol specified methods of birth control, was not breastfeeding and had a negative serum pregnancy test prior to the Treatment Phase.
  • For those subjects taking phosphate binders prior to the study, the subject had to have been on a stable (type and dose) phosphate binder at least 4 weeks prior to the Pretreatment Phase.
  • For entry into the Pretreatment Phase, the subject must have had a calcium level <= 10.5 mg/dL and a CaxP level <= 65 mg2/dL2.
  • For entry into the Treatment Phase, the subject must have had iPTH >= 300 pg/mL (determined by Nichols iPTH assay), a calcium level of 8.0 to 10.5 mg/dL, inclusive, and CaxP <= 65 mg2/dL2.
  • Subject voluntarily signed and dated an informed consent, approved by an Institutional Review Board (IRB), after the nature of the study was explained and the subject had the opportunity to ask questions. The informed consent was signed before any study-specific procedures were performed or any medications were withheld.
  • Additional criteria for HD subjects included the following: the subject was diagnosed with CKD Stage 5 and must have been on maintenance HD 3 times a week (TIW) for at least 2 months prior to the Screening Phase and was expected to remain on HD for the duration of the study.
  • Additional criteria for PD subjects, included the following: the subject was diagnosed with CKD Stage 5 and must have been on continuous PD (either continuous cycling peritoneal dialysis [CCPD], continuous ambulatory peritoneal dialysis [CAPD], or a combination of the 2) 7 days per week for at least 2 months prior to the Screening Phase and was expected to remain on this PD regimen for the duration of the study.

Exclusion Criteria

  • Subject had a history of an allergic reaction or significant sensitivity to drugs similar to the study drug.
  • Subject received a partial parathyroidectomy within 1 year prior to the Screening Phase.
  • Subject had acute renal failure within 3 months of the Screening Phase.
  • Subject had chronic gastrointestinal disease, which in the investigator's opinion, may have resulted in clinically significant gastrointestinal malabsorption.
  • Subject had taken aluminum-containing phosphate binders for > 3 weeks in the last 3 months prior to the Screening Phase, or required such medications for > 3 weeks in the study.
  • Subject had a current malignancy (with the exception of basal or squamous cell carcinoma of the skin), or clinically significant liver disease, in the opinion of the investigator.
  • Subject had a history of drug or alcohol abuse within 6 months prior to the Screening Phase.
  • Subject had evidence of poor compliance with diet, medication or HD/PD that may have interfered, in the investigator's opinion, with adherence to the protocol.
  • Subject had participated in any investigational drug or device study within 4 weeks prior to the Treatment Phase.
  • Subject was taking calcitonin, maintenance IV or oral glucocorticoids, cinacalcet, bisphosphonates, vitamin D compounds (other than study drug), or other drugs that may have affected calcium or bone metabolism, other than females on stable estrogen and/or progestin therapy.
  • Subject was known to be human immunodeficiency virus (HIV) positive.
  • For any reason, subject was considered by the investigator to be an unsuitable candidate to receive Zemplar.
  • Additional exclusion criteria for PD subjects, were: Subject had active peritonitis within 1 month prior to the Screening Phase; Subject had more than 1 episode of peritonitis within 4 months prior to the Screening Phase.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00091975


Locations
United States, California
California Institute of Renal Research
San Diego, California, United States, 92120
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 60057
United States, Florida
Associates in Nephrology
Fort Meyers, Florida, United States, 33908
University of Florida
Gainesville, Florida, United States, 32610
Outcomes Research International, Inc.
Hudson, Florida, United States, 34667
United States, Illinois
Evanston Northwestern Healthcare
Evanston, Illinois, United States, 60201
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112-2699
United States, Missouri
Washington University Medical Center
St. Louis, Missouri, United States, 63108
St. Louis University
St. Louis, Missouri, United States, 63110
United States, Nevada
Nea Research
Las Vegas, Nevada, United States, 89102
United States, Ohio
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45267-0585
United States, Oregon
Northwestern Renal Clinic, INC.
Portland, Oregon, United States, 97210
United States, Tennessee
Nephrology Associates, P.C.
Nashville, Tennessee, United States, 37205
United States, Texas
Kidney Associates, PLLC
Houston, Texas, United States, 77030
University of Texas Health Center at San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Abbott
Investigators
Study Director: Laura A Williams, M.D., MPH Abbott
More Information
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Additional Information:
Product Information  This link exits the ClinicalTrials.gov site

ClinicalTrials.gov Identifier: NCT00091975     History of Changes
Other Study ID Numbers: M03-635
First Posted: September 22, 2004    Key Record Dates
Last Update Posted: January 19, 2011
Last Verified: July 2006

Keywords provided by Abbott:
Chronic Kidney Disease

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
 Renal Insufficiency
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs