| Trial ID: | L0664 |
| Source ID: | NCT02332811
|
| Associated Drug: |
Sevelamer Carbonate 800mg
|
| Title: |
An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic CKD Patients
|
| Acronym: |
TOSCANA
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Renal Failure Chronic
|
| Interventions: |
DRUG: sevelamer carbonate 800mg|DRUG: sevelamer carbonate 2.4 g
|
| Outcome Measures: |
Primary: 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, up to 8 weeks |
|
| Sponsor/Collaborators: |
Sponsor: Genzyme, a Sanofi Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
96
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2013-10
|
| Completion Date: |
2014-07
|
| Results First Posted: |
|
| Last Update Posted: |
2016-12-23
|
| Locations: |
Russia, Moscow, Russian Federation
|
| URL: |
https://clinicaltrials.gov/show/NCT02332811
|