Treatment for Patients With Secondary Hyperparathyroidism of End-Stage Renal Disease (ESRD)
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 16, 2005 | ||||
| Last Updated Date | April 22, 2010 | ||||
| Start Date ICMJE | November 2002 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Examine PTH and Ca x P control when cinacalcet is administered in the setting of flexible dosing of vitamin D sterols. | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00110929 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Examine safety and tolerability of cinacalcet. | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Treatment for Patients With Secondary Hyperparathyroidism of End-Stage Renal Disease (ESRD) | ||||
| Official Title ICMJE | 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) | ||||
| 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). |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE | End Stage Renal Disease | ||||
| Intervention ICMJE | Drug: AMG 073 | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Sprague SM, Evenepoel P, Curzi MP, González MT, Husserl FE, Kopyt N, Sterling LR, Mix C, Wong G. Simultaneous control of PTH and CaxP Is sustained over three years of treatment with cinacalcet HCl. Clin J Am Soc Nephrol. 2009 Sep;4(9):1465-76. Epub 2009 Aug 20. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 850 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | 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 |
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00110929 | ||||
| Other Study ID Numbers ICMJE | 20020158 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Global Development Leader, Amgen Inc. | ||||
| Study Sponsor ICMJE | Amgen | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Amgen | ||||
| Verification Date | April 2010 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||