| Trial ID: | L0373 |
| Source ID: | NCT00267514
|
| Associated Drug: |
Sevelamer Carbonate (Renvela®) Sevelamer Hydrochloride (Renagel ®)
|
| Title: |
Study to Demonstrate Equivalence of Sevelamer Carbonate Powder and Sevelamer HCl Tablets in Haemodialysis Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease
|
| Interventions: |
DRUG: sevelamer carbonate (Renvela®) sevelamer hydrochloride (Renagel ®)|DRUG: sevelamer hydrochloride (Renagel ®) sevelamer carbonate (Renvela®)
|
| Outcome Measures: |
Primary: Demonstrate the equivalence of sevelamer carbonate powder to sevelamer hydrochloride tablets dosed three times per day (TID) with meals on the control of serum phosphorus levels, Up to 13 weeks|Evaluate the safety and tolerability of sevelamer carbonate powder compared to sevelamer hydrochloride tablets dosed TID with meals, Up to 13 weeks | Secondary: Compare the effects of sevelamer carbonate powder to sevelamer hydrochloride tablets when dosed three times a day with meals on: serum calcium-phosphorus product, Up to 13 weeks|serum lipid profile (total cholesterol, high density lipoprotein [HDL] and low density lipoprotein [LDL] and triglycerides), Up to 13 weeks
|
| Sponsor/Collaborators: |
Sponsor: Genzyme, a Sanofi Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
31
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2006-01
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| Completion Date: |
2007-05
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| Results First Posted: |
|
| Last Update Posted: |
2015-03-18
|
| Locations: |
Southmead Hospital, Bristol, BS10 5NB, United Kingdom|Addenbrooks NHS Trust, Cambridge, CB2 2QQ, United Kingdom|The Royal London Hospital, London, E1 1BB, United Kingdom|Guy's Hospital, London, SE1 9RT, United Kingdom|Manchester Royal Infirmary, Manchester, M13 9WL, United Kingdom|Hope Hospital, Manchester, M6 8HD, United Kingdom|Norfolk and Norwich University Hospital, Norwich, NR4 7UY, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT00267514
|
