Phase 3
N=182
Head to Head Study Against Sevelamer Hydrochloride
Chronic Kidney Disease, Stage 5
Bottom Line
View on ClinicalTrials.gov: NCT00441545 ↗Enrolled (actual)
182
Serious AEs
11.4%
Results posted
Aug 2009
Primary outcome: Primary: Change From Baseline in Serum Phosphorus Levels at 4 Weeks — -1.73; -1.44 mg/dL — p=0.1130
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fosrenol (Lanthanum Carbonate) (Drug); Sevelamer hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Serum Phosphorus Levels at 4 Weeks |
-1.73; -1.44 | 0.1130 |
| SECONDARY Change From Baseline in Serum Calcium Levels at 4 Weeks |
0.06; -0.06 | 0.0249 sig |
| SECONDARY Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks |
225.46; 225.46; 296.48; 291.18 | — |
| SECONDARY Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 Weeks |
42.7; 34.6 | — |
Summary
To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.
Eligibility Criteria
Inclusion Criteria
- Adults with end stage renal disease who are receiving dialysis
Exclusion Criteria
- Subjects with significant gastrointestinal disorders
- Subjects who are pregnant or nursing
- Subjects currently taking lanthanum carbonate, sevelamer hydrochloride, cinacalcet hydrochloride
- Subjects who are HIV positive
- Subjects with clinical significant liver disease
Data sourced from ClinicalTrials.gov (NCT00441545). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.