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A Research Study for Patients With End-Stage Renal Disease (ESRD)

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00110890
First received: May 16, 2005
Last updated: February 11, 2011
Last verified: February 2011
History of Changes
  Purpose
The purpose of this study is to evaluate the ability of a treatment strategy, that includes cinacalcet for the management of secondary hyperparathyroidism, to control parathyroid hormone (PTH) compared with the standard of care.

Condition Intervention Phase
End Stage Renal Disease
 Drug: cinacalcet
Other: Standard of care
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Randomised Study Using Cinacalcet to Improve Achievement of Kidney Disease Outcomes Quality Initiative (K/DOQI) Targets in Patients With ESRD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Number of Participants With Mean PTH ≤ 300 pg/mL [ Time Frame: Efficacy Assessment Phase (weeks 17 to 23) ] [ Designated as safety issue: No ]
    Number of participants with mean parathyroid hormone (PTH) ≤ 300 pg/mL during the efficacy assessment phase


Secondary Outcome Measures:
  • Number of Participants With Mean Ca x P < 55 mg^2/dL^2 and iPTH ≤ 300 pg/mL [ Time Frame: Efficacy Assesment Phase (weeks 17-23) ] [ Designated as safety issue: No ]
    Number of participants with mean calcium x phosphorus (Ca x P) < 55 mg^2/dL^2 and intact parathyroid hormone (iPTH) ≤ 300 pg/mL during the efficacy assessment phase

  • Number of Participants With Mean Ca x P < 55 mg^2/dL^2 [ Time Frame: Efficacy Assessment Phase (weeks 17 to 23) ] [ Designated as safety issue: No ]
    Number of participants with mean calcium x phosphorus (Ca x P) < 55 mg^2/dL^2 during the efficacy assessment phase

  • Number of Participants With Mean Serum Ca < 9.5 mg/dL [ Time Frame: Efficacy Assessment Phase (weeks 17-23) ] [ Designated as safety issue: No ]
    Number of participants with mean serum calcium (Ca) < 9.5 mg/dL during the efficacy assessment phase

  • Number of Participants With Mean Serum P < 5.5 mg/dL [ Time Frame: Efficacy Assessment Phase (weeks 17 to 23) ] [ Designated as safety issue: No ]
    Number of participants with mean serum phosphorus (P) < 5.5 mg/dL during the efficacy assessment phase
Enrollment: 552
Study Start Date: May 2004
Study Completion Date: September 2007
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard of care
Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the K/DOQI PTH, serum calcium, phosphorus, and Ca x P treatment targets.
 Other: Standard of care
Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the K/DOQI PTH, serum calcium, phosphorus, and Ca x P treatment targets.
Cinacalcet
Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on iPTH values.
 Drug: cinacalcet
Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg.

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ESRD patients requiring maintenance dialysis (haemodialysis, haemodiafiltration, haemofiltration, or peritoneal dialysis) for at least 1 month
  • The mean of 2 iPTH determinations within 21 days before randomization and drawn at least 2 days apart must be greater than or equal to 300 pg/mL (31.8 pmol/L) and less than 800 pg/mL (84.8 pmol/L). If biPTH is determined, the mean levels must be greater than or equal to 150 pg/mL (15.9 pmol/L) and less than 410 pg/mL (43.5 pmol/L)
  • The mean of 2 serum calcium determinations (corrected for albumin) drawn on the same day as the PTH determinations must be greater than or equal to 8.4 mg/dL (2.1 mmol/L)

Exclusion Criteria:

  • Have an unstable medical condition, defined as having been hospitalised, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator
  • Have had a parathyroidectomy in the 6 months before day 1
  • Have received vitamin D therapy for less than 21 days before day 1 or required a change in prescribed vitamin D brand or dose within 21 days before day 1. If subjects are not prescribed vitamin D therapy, they must remain free of vitamin D therapy for the 21 days before day 1.
  • Received, within 21 days before day 1 of the dose titration phase, therapy with medications that are predominantly metabolized by the enzyme CYP2D6 and have a narrow therapeutic index (e.g., flecainide, vinblastine, thioridazine, and most tricyclic antidepressants). The tricyclic antidepressant amitriptyline is permitted. - Experienced a myocardial infarction within 3 months prior to day 1
  • Are currently enrolled in, or have not yet completed at least 30 days before day 1, other invasive investigational device or investigational drug trials, or are receiving other investigational agents (experimental dialysis machines are acceptable)
  • Have a gastrointestinal disorder that may be associated with impaired absorption or orally administered medications or an inability to swallow tablets
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110890

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site
FDA-approved Drug Labeling  This link exits the ClinicalTrials.gov site

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00110890     History of Changes
Other Study ID Numbers: 20030187 
Study First Received: May 16, 2005
Results First Received: October 15, 2010
Last Updated: February 11, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Secondary HyperParaThyroidism (SHPT)
Dialysis, End Stage Renal Disease (ESRD)
KDOQI, Cinacalcet
Clinical Trial, Amgen

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

ClinicalTrials.gov processed this record on September 28, 2016