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| Sponsor: | Genzyme |
|---|---|
| Information provided by: | Genzyme |
| ClinicalTrials.gov Identifier: | NCT00267514 |
Purpose
The purpose of this study is to determine if sevelamer carbonate powder is an effective treatment for the control of serum phosphorous levels in patients on dialysis when compared to sevelamer hydrochloride tablets.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Kidney Disease |
Drug: sevelamer carbonate (Renvela®) sevelamer hydrochloride (Renagel ®) Drug: sevelamer hydrochloride (Renagel ®) sevelamer carbonate (Renvela®) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
| Official Title: | A Randomized, Cross-over Study to Demonstrate Equivalence of Sevelamer Carbonate Powder and Sevelamer Hydrochloride Tablets Dosed Three Times Per Day in Haemodialysis Patients |
| Enrollment: | 31 |
| Study Start Date: | January 2006 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
sevelamer carbonate powder x 4 weeks then, sevelamer hydrochloride x 4 weeks
|
Drug: sevelamer carbonate (Renvela®) sevelamer hydrochloride (Renagel ®)
sevelamer carbonate powder dosed TID with meals for four weeks followed by sevelamer hydrochloride tablets dosed TID with meals for four weeks
|
|
2
sevelamer hydrochloride x 4 weeks then, sevelamer carbonate powder x 4 weeks
|
Drug: sevelamer hydrochloride (Renagel ®) sevelamer carbonate (Renvela®)
sevelamer hydrochloride tablets dosed TID with meals for four weeks followed by sevelamer carbonate powder dosed TID with meals for four weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Have the following documented local laboratory measurements:
Have the following central laboratory measurements:
Exclusion Criteria:
Contacts and Locations| United Kingdom | |
| Guy's Hospital | |
| London, United Kingdom, SE1 9RT | |
| The Royal London Hospital | |
| London, United Kingdom, E1 1BB | |
| Hope Hospital | |
| Manchester, United Kingdom, M6 8HD | |
| Norfolk and Norwich University Hospital | |
| Norwich, United Kingdom, NR4 7UY | |
| Southmead Hospital | |
| Bristol, United Kingdom, BS10 5NB | |
| Manchester Royal Infirmary | |
| Manchester, United Kingdom, M13 9WL | |
| Addenbrooks NHS Trust | |
| Cambridge, United Kingdom, CB2 2QQ | |
| Study Director: | Medical Monitor | Genzyme |
More Information
| Responsible Party: | Genzyme Corporation ( Medical Monitor ) |
| Study ID Numbers: | SVCARB00205 |
| Study First Received: | December 20, 2005 |
| Last Updated: | August 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00267514 History of Changes |
| Health Authority: | United Kingdom: Research Ethics Committee |
|
Hemodialysis |
|
Sevelamer Renal Insufficiency Molecular Mechanisms of Pharmacological Action Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Chelating Agents Kidney Diseases Pharmacologic Actions Kidney Failure |