Treatment of Hyperphosphataemia. MedDRA version: 18.0 Level: LLT Classification code 10020712 Term: Hyperphosphatemia System Organ Class: 100000004861
Conditions
Interventions
Product Name: Fosrenol Oral Powder 250mg
Product Code: SPD405
Pharmaceutical Form: Oral powder
CAS Number: 54451-24-0
Current Sponsor co
Sponsors
Shire Pharmaceutical Development Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subject cannot be enrolled in the study before all of the following inclusion criteria(including test results) are met. 1.Aged 10 years to 6.0mg/dL (1.94mmol/L) - Age 12 years and older: Serum phosphorus >5.5mg/dL (1.78mmol/L) 6. Ability to provide written, signed and dated (personally or via an LAR) informed consent/and assent, as applicable, to participate in the study. Are the trial subjects under 18? yes Number of subjects for this age range: 72 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Current or recurrent disease (eg, cardiovascular, liver, unstable and uncontrolled gastrointestinal, malignancy, or other conditions) other than CKD or end-stage renal disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments. 2. Current or relevant history of physical or psychiatric illness, any medical disorder (except for CKD or end-stage renal disease and related co-morbidities) that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures. 3. Unable to eat solid or semi-solid foods or on Total Enteral Alimentation. 4. Serum PTH >700pg/mL. 5. Known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any of the stated ingredients. 6. History of alcohol or other substance abuse within the last year. 7. Current use of any medication (including over-the-counter, herbal, or homeopathic preparations) that could affect (improve or worsen) the condition being studied, or could affect the action, absorption, or disposition of the investigational product(s), or clinical or laboratory assessment. (Current use is defined as use within 1 day.) See Section 5 (Prior and Concomitant Treatment) for a list of prohibited and restricted medications. 8. Weight and age of subject are outside local applicable criteria for blood sample volumelimits. 9. Use of another investigational product within 30 days prior to receiving the first dose of investigational product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: End of Part 2;Main Objective: To compare the percentage of subjects achieving age-specific Kidney Disease Outcomes Quality Initiative (KDOQI) targets for serum phosphorus in hyperphosphataemic children and adolescents with chronic kidney disease (CKD) on dialysis following treatment with calcium carbonate for 8 weeks and lanthanum carbonate for 8 weeks.; Secondary Objective: 1. To compare mean changes from baseline in serum phosphorus, calcium, and calcium-phosphorus product in hyperphosphataemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate for 8 weeks and lanthanum carbonate for 8 weeks. 2. To describe the pharmacokinetics (maximum plasma concentration [Cmax] and area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC0-t]; bodyweight- normalised) of lanthanum carbonate in hyperphosphataemic children and adolescents aged 10 years to -15%. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline in serum phosphorus, calcium and calcium-phosphorus product levels at the last visit of each 8-week treatment period during Part 2 and monthly during the 10-month extension phase. • Biochemical bone markers: bone ALP, osteocalcin, TRAP and FGF-23, PTH, sclerostin and fetuin-A before and after each treatment period in Part 2, and at the end of Part 3 (Visits 2.0, 2.4, 2.5, 2.8, and 3.9). • Height or length, head circumference and weight at each visit. ;Timepoint(s) of evaluation of this end point: End of Part 3 | — |
Countries
Argentina, Bulgaria, Chile, Czech Republic, Germany, Hungary, Poland, Romania, Russian Federation, Turkey
Contacts
Public ContactGlobal Medical Information
Shire Pharmaceutical Development Ltd.
Outcome results
None listed