Trials / Completed
CompletedNCT00132431
START: Sensipar Treatment Algorithm to Reach K/DOQI Targets in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism
Sensipar Treatment Algorithm to Reach K/DOQI Targets in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 300 (planned)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this research is to study the effects and safety of Sensipar approved by the Food and Drug Administration (FDA) in patients with kidney failure who are being treated with dialysis and have uncontrolled secondary hyperparathyroidism (HPT).
Detailed description
The purposes of this study are: - To assess the effectiveness of a treatment algorithm that includes Sensipar on bio-intact parathyroid hormone (biPTH), adjusted serum calcium (Ca), serum phosphorus (P), and calcium-phosphorus product (Ca x P) levels in the management of SHPT in CKD subjects on dialysis by determining achievement of National Kidney Foundation Kidney Disease Outcomes Quality Initiative (K/DOQI) Guideline targets. - To assess the use of vitamin D sterols and phosphate binders when Sensipar is incorporated in the treatment of SHPT. - To assess the safety and tolerability of Sensipar.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sensipar |
Timeline
- Start date
- 2004-07-01
- Completion
- 2005-07-01
- First posted
- 2005-08-22
- Last updated
- 2009-02-13
Source: ClinicalTrials.gov record NCT00132431. Inclusion in this directory is not an endorsement.