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Study for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00042432
First Posted: August 1, 2002
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:
Amgen
  Purpose
This study will assess an investigational medication for patients with chronic renal insufficiency (pre-dialysis) who have secondary hyperparathyroidism.

Condition Intervention Phase
Secondary Hyperparathyroidism Chronic Renal Insufficiency Drug: cinacalcet (AMG 073) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Study of an Investigational Medication for Secondary Hyperparathyroidism in Chronic Renal Insufficiency Patients

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase [ Time Frame: Efficacy assessment phase (weeks 12-18) ]
    Reduction in mean intact parathyroid hormone (iPTH) of ≥ 30% within the participant during the efficacy assessment phase


Secondary Outcome Measures:
  • Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase [ Time Frame: Baseline, efficacy assessment phase (weeks 12-18) ]
    Percentage change from baseline in mean intact parathyroid hormone (iPTH) during the efficacy assessment phase


Enrollment: 54
Study Start Date: June 2002
Study Completion Date: August 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cinacalcet (AMG 073) Drug: cinacalcet (AMG 073)
Initially receive 1 tablet of study medication (cinacalcet or placebo) once daily. Possible sequential dose titrations are 30, 60, 90, 120, 180mg cinacalcet or placebo) daily. The titration phase was 12 weeks and the efficacy assessment phase was 6 weeks.
Placebo Comparator: Placebo Drug: cinacalcet (AMG 073)
Initially receive 1 tablet of study medication (cinacalcet or placebo) once daily. Possible sequential dose titrations are 30, 60, 90, 120, 180mg cinacalcet or placebo) daily. The titration phase was 12 weeks and the efficacy assessment phase was 6 weeks.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Patients must have chronic renal insufficiency (pre-dialysis)
  • Have below normal creatinine clearance
  • Have elevated parathyroid hormone levels

Exclusion Criteria:

  • Pregnant or nursing
  • Heart attack in the last 3 months.
  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): NCT00042432


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

Additional Information:
Publications:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00042432     History of Changes
Other Study ID Numbers: 20010239
First Submitted: July 29, 2002
First Posted: August 1, 2002
Results First Submitted: November 4, 2010
Results First Posted: March 1, 2011
Last Update Posted: May 13, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Neoplasm Metastasis
Renal Insufficiency
Hyperparathyroidism
Hyperparathyroidism, Secondary
Renal Insufficiency, Chronic
Neoplastic Processes
Neoplasms
Pathologic Processes
Kidney Diseases
Urologic Diseases
Parathyroid Diseases
Endocrine System Diseases
Cinacalcet Hydrochloride
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs