Nephrology Clinical Trial
Official title:
A Multi-Center, Observational Registry of Subjects With Secondary Hyperparathyroidism (HPT) and Chronic Kidney Disease (CKD)
| NCT number | NCT00189501 |
| Other study ID # | 20040159 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | September 12, 2005 |
| Last updated | December 20, 2007 |
| Start date | December 2004 |
| Verified date | December 2007 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Observational |
Objectives include description of current practices; assessment over time of K/DOQI goals, clinical outcomes, health resource utilization(HRU) and patient reported outcomes (PRO) and the impact of Sensipar® on these parameters
| Status | Completed |
| Enrollment | 1000 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 3 month history of Stage 4 or Stage 5 CKD - A PTH value within 3 months of enrollment - If relevant, completion of Sensipar® study prior to enrolling in Registry Exclusion Criteria: - Females who are pregnant or breast feeding |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
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|---|---|---|---|
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