Hyperphosphataemia in Patients Receiving Haemodialysis for End Stage Renal Disease
Conditions
Interventions
Product Name: Lanthanum Carbonate
Product Code: SPD 405
Pharmaceutical Form: Chewable tablet
INN or Proposed INN: Lanthanum (III) carbonate hydrate
Sponsors
Shire Pharmaceutical Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female patients greater than or equal to 18 years of age receiving haemodialysis for end stage renal disease with a level of serum phosphate>5.9mg/dL (1.9mmol/L) after washout or sub-optimally treated with current phosphate binder. Patients (including those who have undergone renal transplantation in the past) must have received haemodialysis for chronic renal failure three times per week for at least the previous two months. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnant or lactating women. Patients with screening calcium below 8.8mg/dL (2.2mmol/L) or with significant abnormal laboratory values (excluding markers of pathologies associated with chronic renal failure), which in the opinion of the investigator should exclude the patient from the study. Patients with clinically significant uncontrolled concurrent illness a life threatening malignancy or current multiple myeloma or known to be HIV positive. Patients with any significant bowel obstruction, active inflammatory disease, gastrointestinal (GI) motility disorders, abnormal or irregular bowel motion or a history of major GI surgery within the last 6 mnths. Patients who have been in any other clinical trial within the last 30 days or who have previously taken lanthanum carbonate in the last year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess phosphate reduction and control (3.5-5.5mg/dL [1.1-1.8mmol/L]) in patients with End Stage Renal Disease (ESRD) following administration of lanthanum carbonate or sevelamer hydrochloride;Primary end point(s): Serum phosphate reduction and control rate (defined as 3.5-5.5mg/dL [1.1-1.8 mmol/L]); Secondary Objective: To assess: The effects of lanthanum carbonate and sevelamer hydrochloride on serum calcium and calcium phosphate product levels The percentage of patients achieving a reduction in serum calcium-phosphate product to less than or equal to 4.4 (mmol/L)2 (54.56mg2/dL2) following administration of lanthanum carbonate or sevelamer hydrochloride Average daily pill burden, dose levels and compliance The safety and tolerability of lanthanum carbonate Patient satisfaction with treatment | — |
Countries
United Kingdom
Outcome results
None listed