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

A Study to Compare the Efficacy and Safety of an Oral Calcimimetic Agent (AMG 073) When Two Different Vitamin D Regimens Are Used in Subjects With Secondary Hyperparathyroidism of End-Stage Renal Disease (ESRD)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00110929

Enrollment

850

Registered

2005-05-17

Start date

2002-11-30

Completion date

Unknown

Last updated

2010-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease

Keywords

Sensipar®, Secondary HPT, Mimpara®, Cinacalcet, calcimimetic, End-Stage Renal Disease (ESRD)

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 hyperparathyroidism (HPT).

Interventions

DRUGAMG 073

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Examine PTH and Ca x P control when cinacalcet is administered in the setting of flexible dosing of vitamin D sterols.	—

Secondary

Measure	Time frame
Examine safety and tolerability of cinacalcet.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026