drugset / Trial / NCT02332811
An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic CKD Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
Primary Objective: Evaluate the reduction in serum phosphorus from baseline to end of study with Sevelamer carbonate tablets 800 mg and Sevelamer carbonate Powder 2.4 g in chronic kidney disease (CKD) patients both on haemodialysis and not on dialysis Secondary Objective: Evaluate the safety on the basis of adverse events, changes in laboratory values and vital signs from baseline (Day 0) to Day 56 (End of treatment/ End of Study)
Timeline
- Start
- 2013-10
- Primary completion
- 2014-07
- Completion
- 2014-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | sevelamer | Other / unclassified | 800 mg | Oral |
| Subject | sevelamer | Other / unclassified | 2.4 g | Oral |