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Study Complete
Sponsor ID
20030219

Study To Evaluate the Status of Subjects that Discontinued Participation in a Qualifying Amgen Sponsored AMG 073 Study Due to Kidney Transplantation

Sponsor ID
20030219
Clinicaltrials.gov ID
NCT00110656
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The purpose of this study is to collect local laboratory data on immunoreactive parathyroid hormone (iPTH), calcium and phosphorus levels and estimated glomerular filtration rate (GFR) at approximately 1 week, 1 month, 3 months, 6 months and 12 months after the kidney transplant.

Additional Study Details

Phase
N/A
Product
cinacalcet hcl
Type
Observational
Masking
N/A
Enrollment
38
Additional Study Details

Protocol Summary

Primary Outcome Measures

PTH Values

Timeframe: 12 months post kidney translplant

Secondary Outcome Measures

Calcium and Phosphorus

Timeframe: 12 months post kidney transplant

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Kidney Transplant
    • Sex
    All
    Trial Dates
    Mar 2004 - Sep 2004
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Patients who withdrew from 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) due to kidney transplantation.
    Exclusion Criteria:
    - Patient has any kind of disorder that compromises the ability of the subject to give written informed consent