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Trial record 2 of 6 for:    "Hyperthyroidism" | "Calcium"

Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis

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: NCT01181531
Recruitment Status : Completed
First Posted : August 13, 2010
Results First Posted : April 25, 2014
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE August 12, 2010
First Posted Date  ICMJE August 13, 2010
Results First Submitted Date  ICMJE December 3, 2013
Results First Posted Date  ICMJE April 25, 2014
Last Update Posted Date October 17, 2018
Actual Study Start Date  ICMJE October 1, 2010
Actual Primary Completion Date July 17, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2014)
Percent Change From Baseline in Mean PTH During Efficacy Assessment Phase (EAP) [ Time Frame: Baseline to week 40-52 ]
Mean PTH during EAP is defined as the mean of values at study weeks 40, 44, 48 and 52
Original Primary Outcome Measures  ICMJE
 (submitted: August 12, 2010)
To demonstrate the efficacy of treatment with cinacalcet compared to traditional vitamin D therapy, given orally or intravenously (IV), for controlling plasma parathyroid hormone(PTH) levels among hemodialysis subjects with secondary hyperparathyroidism [ Time Frame: 1 year ]
Change History Complete list of historical versions of study NCT01181531 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2014)
  • Treatment Comparison of >=30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase (EAP) [ Time Frame: Baseline to week 40-52 ]
    Number of participants achieving a >=30% Reduction From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)
  • Treatment Comparison of Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP) [ Time Frame: week 40-52 ]
    Number of participants achieving Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2010)
To demonstrate a clinically meaningful reduction in plasma parathyroid hormone levels after 1 year of treatment with cinacalcet compared with traditional vitamin D therapy [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis
Official Title  ICMJE A Multicenter, Randomized, Open Label Study to Compare the Efficacy of Cinacalcet Versus Traditional Vitamin D Therapy for Management of Secondary Hyperparathyroidism Among Subjects Undergoing Hemodialysis
Brief Summary The purpose of this study is to determine the efficacy of treatment with cinacalcet to manage plasma parathyroid levels as to compared traditional vitamin D therapy, whether given orally or intravenously, among hemodialysis subjects with secondary hyperparathyroidism when the doses are adjusted appropriately to maintain serum calcium and phosphorous levels with currently recommended ranges.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hyperparathyroidism, Secondary
Intervention  ICMJE
  • Drug: Traditional Vitamin D Therapy
    Traditional vitamin D therapy (eg, calcitriol, paricalcitol, alfacalcidol, doxercalciferol), to manage secondary hyperparathyroidism (SHPT) in this study will be administered according to strategies that have been used in clinical practice and that conform to current therapeutic recommendations and available clinical practice guidelines and product labeling.
  • Drug: Cinacalcet
    Subjects randomized to treatment with cinacalcet will receive an initial oral dose of 30 mg once daily. Doses will be titrated incrementally to 60, 90,120, and 180 mg per day based upon periodic measurements of serum calcium and plasma PTH levels. Cinacalcet is formulated as light green tablets in 30, 60, and 90 mg free-based equivalents. Tablets will be 30, 60, and 90 mg, graduated in size, smallest to largest. Combinations of these 3 fixed dosage formulations will be used to achieve the 120 and 180 mg daily doses.
Study Arms  ICMJE
  • Active Comparator: Traditional Vitamin D Therapy
    Intervention: Drug: Traditional Vitamin D Therapy
  • Experimental: Cinacalcet
    Intervention: Drug: Cinacalcet
Publications *

*   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
Actual Enrollment  ICMJE
 (submitted: August 25, 2011)
312
Original Estimated Enrollment  ICMJE
 (submitted: August 12, 2010)
260
Actual Study Completion Date  ICMJE August 14, 2012
Actual Primary Completion Date July 17, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 years at screening
  • Treated with maintenance hemodialysis 3 times a week for ≥ 3 months prior to screening
  • Informed consent provided by the study candidate
  • For subjects NOT receiving cinacalcet and/or vitamin D therapy for SHPT within 60 days prior to enrollment: Plasma PTH levels ≥ 450 pg/mL (50 pmol/L) during screening, as obtained from the central laboratory and, Serum corrected total calcium ≥ 8.4 mg/dL (2.1 mmol/L) and < 10.2 mg/dL (2.55 mmol/L) during screening, as obtained from the central laboratory

Exclusion Criteria:

  • Parathyroidectomy in the 12 weeks before the date of informed consent
  • History of seizure within 12 weeks prior to randomization
  • Scheduled for kidney transplant
  • Parathyroidectomy anticipated within the next 6 months
  • Liver function tests > than 2 x the Upper Limit of Normal
  • Prior use of bisphosphonates, or expected to receive bisphosphonates during the trial
  • Subject has previously enrolled in this study
  • General
  • Other investigational procedures are excluded
  • Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)
  • Subject (male or female) is not willing to use highly effective contraception during treatment and for at least one month (women) and 3 months (men) after the end of treatment
  • Subject is pregnant or breast feeding, or planning to become pregnant during study or within 1 month after the end of treatment Male subject with a pregnant partner who is not willing to use a condom during treatment and for at least 1 month after the end of treatment
  • Subject has known sensitivity or intolerance to any of the protocol required therapies
  • Subject will not be available for protocol-required study visits, to the best of the subject and investigator's knowledge
  • Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures
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 Not Provided
Removed Location Countries Australia,   Canada,   Puerto Rico,   Russian Federation,   United States
 
Administrative Information
NCT Number  ICMJE NCT01181531
Other Study ID Numbers  ICMJE 20090686
PARADIGM ( Other Identifier: Amgen )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date September 2018

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