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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00110929 |
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).
Condition | Intervention | Phase |
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End Stage Renal Disease |
Drug: AMG 073 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment |
Official Title: | 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) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20020158 |
Study First Received: | May 16, 2005 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00110929 |
Health Authority: | United States: Food and Drug Administration |
Sensipar® Secondary HPT Mimpara® |
Cinacalcet calcimimetic End-Stage Renal Disease (ESRD) |
Parathyroid Diseases Renal Insufficiency Kidney Failure, Chronic Ergocalciferols Endocrine System Diseases Hyperparathyroidism, Secondary Vitamin D |
Hyperparathyroidism Urologic Diseases Renal Insufficiency, Chronic Neoplasm Metastasis Kidney Diseases Endocrinopathy Kidney Failure |
Neoplasms Neoplastic Processes Pathologic Processes |