A phase IV, open-label, multi-centre trial evaluating the conversion from standard phosphate binder therapy to Fosrenol in chronic kidney disease stage 5 patients on haemodialysis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-003364-64-GB

Enrollment

760

Registered

2007-01-05

Start date

2007-05-08

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperphosphataemia in patients with end-stage renal disease receiving haemodialysis MedDRA version: 8.1 Level: LLT Classification code 10020712 Term: Hyperphosphatemia

Interventions

Trade Name: Fosrenol 750mg Chewable Tablets Product Name: Lanthanum Carbonate Product Code: SPD405 Pharmaceutical Form: Chewable tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Aged 18 or over and receiving stable regimen of haemodialysis (three times a week) for CKD (stage 5) for at least 2 months prior to screening. Females must be non-pregnant and non-lactating. On a stable phosphate binder dose (no change in medication or dose for one month) with screening serum phosphorus levels of between 5.6 and 7.5 mg/dL inclusive. 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: Subjects with a corrected serum calcium level 500pg/ml or a history of parathyroidectomy within 12 months of screening. Any significant GI disorders (including bowel obstruction, active, inflammatory bowel disease, GI motility disorders, abnormal or irregular bowel motion, major GI surgery in last 6 months. Subjects receiving aluminium, magnesium, or combination therapy other than sevelamer HCl and calcium as a phosphate binder.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the percentage of subjects who have serum phosphorus levels controlled to <or= 1.78mmol/L (<or=5.5mg/dl) following treatment with Fosrenol compared to their previous phosphate binder; Secondary Objective: To assess the following: If Fosrenol can maintain serum phosphorus levels in subjects converting to Fosrenol from their previous phosphate binder therapy. If Fosrenol can reduce serum phosphorus levels in subjects converting to Fosrenol from their previous phosphate binder therapy. To assess the control of serum calcium-phosphorus product. To assess the average dose of Fosrenol. To assess the safety and tolerability of Fosrenol ;Primary end point(s): The percentage of subjects acheiving serum phosphorus levels of less than or equal to 1.78mmol/L following treatment with Fosrenol at week 12 compared to treatment with their previous phosphate binder therapy.	—

Measure

Time frame

Main Objective: To assess the percentage of subjects who have serum phosphorus levels controlled to <or= 1.78mmol/L (<or=5.5mg/dl) following treatment with Fosrenol compared to their previous phosphate binder; Secondary Objective: To assess the following: If Fosrenol can maintain serum phosphorus levels in subjects converting to Fosrenol from their previous phosphate binder therapy. If Fosrenol can reduce serum phosphorus levels in subjects converting to Fosrenol from their previous phosphate binder therapy. To assess the control of serum calcium-phosphorus product. To assess the average dose of Fosrenol. To assess the safety and tolerability of Fosrenol ;Primary end point(s): The percentage of subjects acheiving serum phosphorus levels of less than or equal to 1.78mmol/L following treatment with Fosrenol at week 12 compared to treatment with their previous phosphate binder therapy.

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Countries

Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026