Trials / Completed
CompletedNCT01231438
Treatment of Early Stage Renal Failure With Active Vitamin D or a Phosphate Binder.
An Open, Randomized, Crossover Phase 2 Pilot Study of Treatment of Stage 3B Renal Failure With Active Vitamin D or a Phosphate Binder to Evaluate the Effect on the FGF23 and PTH Levels.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Helse Stavanger HF · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Patients with reduced renal function normally develop hyperparathyroidism, which in turn is associated with increased cardiovascular risk and de-calcification. Hyperparathyroidism may be enhanced by an increased level of FGF23 which is often seen in the early stage of renal failure. This pilot study will investigate the FGF23-lowering effect of early initiation of treatment with a phosphate binder versus active vitamin D in an open crossover design.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Renvela | 800mg t.i.d. over 2 weeks |
| DRUG | Etalpha | 0.25ug o.d. for 2 weeks |
Timeline
- Start date
- 2010-10-01
- Primary completion
- 2011-03-01
- Completion
- 2011-03-01
- First posted
- 2010-11-01
- Last updated
- 2012-11-09
Locations
2 sites across 1 country: Norway
Source: ClinicalTrials.gov record NCT01231438. Inclusion in this directory is not an endorsement.