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Research Study Evaluating Cinacalcet for Patients With End Stage Renal Disease (ESRD)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: June 13, 2005
Last Update Posted: May 13, 2013
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.
Information provided by (Responsible Party):
The purpose of this study is to observe the effects of a treatment strategy that incorporates cinacalcet HCl into the management of secondary hyperparathyroidism (HPT) in subjects with ESRD receiving hemodialysis, on bio-intact parathyroid hormone (biPTH), corrected serum calcium, serum phosphorus, and calcium phosphorus product.

Condition Intervention Phase
End Stage Renal Disease Drug: Cinacalcet Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TARGET: Treatment Strategies to Achieve Recommended K/DOQI Goals in ESRD Patients on CinacalceT

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Secondary hyperparathyroidism in people with kidney failure.

Secondary Outcome Measures:
  • Uncontrolled secondary hyperparathyroidism

Estimated Enrollment: 360
Study Start Date: July 2003

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Inclusion Criteria: - Men and women must agree to use highly effective contraceptive measures throughout the study - Prescribed hemodialysis for at least 3 months before study day 1 - Cohort 1: The mean of 2 biPTH determinations obtained from the central laboratory must be greater than 160 pg/mL and less than or equal to 430 pg/mL - The mean of 2 corrected serum calcium determinations obtained from the central laboratory must be greater than or equal to 8.4 mg/dL Exclusion Criteria: - Have an unstable medical condition, defined as having been hospitalized, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator - Subjects receiving oral vitamin D - Pregnant or nursing females - Parathyroidectomy in the 12 weeks 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 antidepressant amitriptyline is permitted - Received, within 21 days before day 1, therapy with medications that are potent inhibitors (e.g. ketoconazole, itraconazole and erythromycin) or inducers (e.g., rifampin and St. John's Wort) of the enzyme CYP3A4. Phenytoin, phenobarbital and carbamazepine are also potent inducers of this enzyme. However, subjects on a stable dose of any of these anti-convulsants at baseline, with no evidence of seizure activity in the past 2 months may be eligible for the study - Experienced a myocardial infarction within 12 weeks prior to day 1 - Other investigational procedures are excluded - Currently enrolled in, or have not yet completed at least 30 days since ending other investigational device or drug trials, or are receiving other investigational agents (experimental dialysis machines are acceptable) - Current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets - Participated in other studies with cinacalcet HCl - Disorder that would interfere with the understanding and giving of informed consent or compliance with protocol requirements
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00113945

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00113945     History of Changes
Other Study ID Numbers: 20020390
First Submitted: June 10, 2005
First Posted: June 13, 2005
Last Update Posted: May 13, 2013
Last Verified: May 2013

Keywords provided by Amgen:
End Stage Renal Disease (ESRD)
secondary hyperparathyroidism
hemodialysis, biPTH
AMG 073, Amgen

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