Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | sevelamer carbonate powder x 4 weeks then, sevelamer hydrochloride x 4 weeks |
|
| 2 | Other | sevelamer hydrochloride x 4 weeks then, sevelamer carbonate powder x 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sevelamer carbonate (Renvela®) sevelamer hydrochloride (Renagel ®) | Drug | sevelamer carbonate powder dosed TID with meals for four weeks followed by sevelamer hydrochloride tablets dosed TID with meals for four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria:
Receiving three times per week haemodialysis for three months or longer.
Taking sevelamer hydrochloride alone (e.g. not using other types of phosphate binders concomitantly) or on combination therapy (e.g. using sevelamer hydrochloride and calcium containing, or metal phosphate binders concomitantly) not exceeding a total daily binder dose of 14.4 g, for at least 60 days prior to screening.
Have the following documented local laboratory measurements:
Have the following central laboratory measurements:
If on vitamin D replacement or calcimimetics therapy, be at a stable dose for at least one month prior to screening and willing to maintain the same dose throughout the duration of the study, except for safety reasons.
Willing to maintain screening doses of lipid medication for the duration of the study, except for safety reasons.
Willing to avoid any intentional changes in diet such as fasting or dieting.
If female and of childbearing potential (pre-menopausal and not surgically sterile), willing to use an effective contraceptive method throughout study, which includes barrier methods, hormones, or intrauterine devices (IUDs).
Willing to stop all calcium supplements not prescribed by the investigator including multivitamins containing calcium.
Willing to refrain from using aluminium, calcium, lanthanum, or magnesium containing antacids throughout duration of the study unless prescribed by the investigator as a calcium supplement per protocol.
Have a level of understanding and willingness to cooperate with all visits and procedures, including telephone contacts, as described in the consent by the study site personnel.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southmead Hospital | Bristol | BS10 5NB | United Kingdom | |||
| Addenbrooks NHS Trust |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| sevelamer hydrochloride (Renagel ®) sevelamer carbonate (Renvela®) | Drug | sevelamer hydrochloride tablets dosed TID with meals for four weeks followed by sevelamer carbonate powder dosed TID with meals for four weeks |
|
| Up to 13 weeks |
| 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 |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069603 | Sevelamer |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
Not provided
Not provided