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

Phase 3CompletedNCT00151918

Shire48 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Kidney Failure, Chronic

Interventions

Lanthanum carbonateDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Mean pre-dialysis serum phosphate level

Time frame: The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)

Secondary Outcomes

Mean pre-dialysis serum calcium product

Time frame: The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)

Mean pre-dialysis calcium-phosphate product

Time frame: The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)

Average daily pill burden

Time frame: Daily throughout for the 8 week Evaluation for Dose Adjustment Period up to the End of Study/ Withdrawal Visit.

Treatment emergent adverse events

Treatment-emergent adverse events (TEAEs) were defined as AEs that had an onset date and time on or after the date and time of the first dose of study medication.

Time frame: Throughout the study period of approximately 7.5 months.

Data from ClinicalTrials.gov

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