Trials / Completed
CompletedNCT01101113
Cinacalcet stUdy for Peritoneal Dialysis Patients In Double Arm on the Lowing Effect OF iPTH Level
Phase 4 Study of Cinacalcet Efficacy in Combination With Vitamin D for the Treatment of Secondary Hyperparathyroidism in Peritoneal Dialysis Patients
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 66 (actual)
- Sponsor
- Seoul National University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed in order to investigate the effect of cinacalcet in combination with routine conventional medical management for treatment of secondary hyperparathyroidism (SHPT) and Ca, P control. This study will compare the efficacy of a cinacalcet-based regimen with unrestricted conventional care (vitamin D and phosphate binders) for achieving the stringent National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) targets for dialysis patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | cinacalcet | cinacalcet 25mg qd or 50 mg qd |
| DRUG | control | vit D + P binder |
Timeline
- Start date
- 2010-09-01
- Primary completion
- 2012-03-01
- Completion
- 2012-06-01
- First posted
- 2010-04-09
- Last updated
- 2012-06-08
Locations
7 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01101113. Inclusion in this directory is not an endorsement.