Status:

COMPLETED

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

Lead Sponsor:

Amgen

Conditions:

End Stage Renal Disease

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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 h...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 1 2002

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

850 Patients enrolled

Trial Details

Trial ID

NCT00110929

Start Date

November 1 2002

Last Update

April 23 2010

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