Overview

Efficacy and Safety of Lanthanum Carbonate and Sevelamer Hydrochloride in Patients Receiving Haemodialysis for End Stage Renal Disease

Status:
Completed
Trial end date:
2005-08-22
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to assess phosphate reduction and control in patients with End Stage Renal Disease treated with either lanthanum carbonate or sevelamer hydrochloride
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shire
Treatments:
Sevelamer
Criteria
Inclusion Criteria:

- Patients receiving haemodialysis for ESRD

- Patients must have received haemodialysis for chronic renal failure three times per
week for at least the previous 2 months

Exclusion Criteria:

- Pregnant or lactating women

- Patients with clinically significant uncontrolled concurrent illness, a
life-threatening malignancy or current multiple myeloma

- Patients who are HIV+

- Patients with any significant bowel obstruction, active inflammatory bowel disease, GI
motility disorders, or a history of major GI surgery within the last 6 months