| December 20, 2005 |
| August 3, 2009 |
| January 2006 |
| March 2007 (final data collection date for primary outcome measure) |
- 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 [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
- Evaluate the safety and tolerability of sevelamer carbonate powder compared to sevelamer hydrochloride tablets dosed TID with meals [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: Yes ]
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- 1.Demonstrate the equivalence of sevelamer carbonate powder to sevelamer hydrochloride tablets dosed three times a day with meals on the control of serum phosphorus levels.
- 2. Evaluate the safety and tolerability of sevelamer carbonate powder compared to sevelamer hydrochloride tablets dosed three times per day (TID) with meals.
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| Complete list of historical versions of study NCT00267514 on ClinicalTrials.gov Archive Site |
- Compare the effects of sevelamer carbonate powder to sevelamer hydrochloride tablets when dosed three times a day with meals on: serum calcium-phosphorus product [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
- serum lipid profile (total cholesterol, high density lipoprotein [HDL] and low density lipoprotein [LDL] and triglycerides) [ Time Frame: Up to 13 weeks ] [ Designated as safety issue: No ]
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| 1. Compare the effects of sevelamer carbonate powder to sevelamer hydrochloride tablets when dosed three times a day with meals on: A) serum calcium-phosphorus product B) serum lipid profile (total cholesterol, HDL and LDL). |
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| Study to Demonstrate Equivalence of Sevelamer Carbonate Powder and Sevelamer HCl Tablets in Haemodialysis Patients |
| A Randomized, Cross-over Study to Demonstrate Equivalence of Sevelamer Carbonate Powder and Sevelamer Hydrochloride Tablets Dosed Three Times Per Day in Haemodialysis Patients |
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. |
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| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
| Chronic Kidney Disease |
- Drug: sevelamer carbonate (Renvela®) sevelamer hydrochloride (Renagel ®)
- Drug: sevelamer hydrochloride (Renagel ®) sevelamer carbonate (Renvela®)
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- Other: sevelamer carbonate powder x 4 weeks then, sevelamer hydrochloride x 4 weeks
- Other: sevelamer hydrochloride x 4 weeks then, sevelamer carbonate powder x 4 weeks
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| |
| |
| Completed |
| 31 |
| May 2007 |
| March 2007 (final data collection date for primary outcome measure) |
Inclusion Criteria:
Exclusion Criteria:
- Have poorly controlled diabetes mellitus or hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition (defined by investigator).
- Have active dysphagia, swallowing disorders, bowel obstruction, or severe gastrointestinal motility disorders.
- Have participated in a study of an investigational drug during the 30 days preceding the start of the screening period.
- Has active ethanol or drug dependence or abuse, excluding tobacco use.
- Have any other condition, which, in the investigator's opinion, will prohibit the patient's participation in the study.
- If female, be pregnant or breast-feeding.
- Have any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not an exclusion.
- Use of anti-arrhythmic or anti-seizure medications for arrhythmia or seizure disorders.
- Have a known hypersensitivity to sevelamer or any of its constituents.
- Have a poor record of compliance with medication.
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| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United Kingdom |
| |
| NCT00267514 |
| Medical Monitor, Genzyme Corporation |
| SVCARB00205 |
| Genzyme |
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| Study Director: |
Medical Monitor |
Genzyme |
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| Genzyme |
| May 2007 |