Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00091975
Recruitment Status : Completed
First Posted : September 22, 2004
Last Update Posted : January 19, 2011
Sponsor:
Information provided by:
Abbott

Tracking Information
First Submitted Date  ICMJE September 20, 2004
First Posted Date  ICMJE September 22, 2004
Last Update Posted Date January 19, 2011
Study Start Date  ICMJE August 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2006)
The efficacy endpoint is achievement of two consecutive > or = 30% decreases from baseline in iPTH levels
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zemplar® Capsule in Reducing Serum Intact Parathyroid Hormone Levels in Chronic Kidney Disease Stage 5 Subjects on Hemodialysis or Peritoneal Dialysis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Kidney Disease
Intervention  ICMJE Drug: Zemplar Capsule
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: February 8, 2006)
78
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00091975
Other Study ID Numbers  ICMJE M03-635
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Abbott
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Laura A Williams, M.D., MPH Abbott
PRS Account Abbott
Verification Date July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP