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Study Complete
Sponsor ID
20020158

Treatment for Patients with Secondary Hyperparathyroidism of End-Stage Renal Disease (ESRD)

Sponsor ID
20020158
Clinicaltrials.gov ID
NCT00110929
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The purpose of this research is to study the efficacy and safety of AMG 073 in patients with kidney failure who are being treated with hemodialysis or peritoneal dialysis and who also have secondary hyperparathyroidism (HPT).

Additional Study Details

Phase
Phase 2
Product
cinacalcet hcl
Type
Interventional
Masking
None (Open Label)
Enrollment
850
Additional Study Details

Protocol Summary

Primary Outcome Measures
Not Available
Secondary Outcome Measures
Not Available

Study Documents

Study Synopsis
Available Language(s): English
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Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Kidney Disease
    • Sex
    All
    Trial Dates
    Nov 2002 - N/A
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Completed one of the qualifying studies (i.e., patient previously took part in an Amgen study investigating the drug AMG 073 and its effects on secondary hyperparathyroidism [HPT]; in particular parathyroid hormone [PTH], calcium and phosphorus levels in blood associated with kidney failure) - Must agree to use, in the opinion of the principal investigator, highly effective contraceptive measures throughout the study
    Exclusion Criteria:
    - Pregnant or nursing females - Experienced a myocardial infarction within 3 months before day 1 - 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