Hyperphosphatemia
Conditions
Keywords
Chronic kidney disease not on dialysis, Lanthanum carbonate
Brief summary
The objective of this study is to investigate the efficacy and safety of lanthanum carbonate 750 to 2,250 mg in Japanese Chronic Kidney Disease Stage 3, 4 and 5 subjects not on dialysis.
Interventions
Daily dose: 750-2250mg 3 times a dayfor 8 weeks.
DRUGPlacebo
daily dose: 3 tablets TID for 8 weeks.
Sponsors
Shire
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female patients aged 20 years or above at the time of informed consent * Chronic Kidney Disease patients with Epidermal growth factor receptor (eGFR) under 60 ml/min/1.73m2 (stage 3, 4 and 5) who have not been on dialysis * Patients who had been in the care of a physician for Chronic Kidney Disease for \>2 months and was not expected to begin dialysis for at least 4 months * Patients with serum phosphate levels 5.6 mg/dL to 11.0 mg/dL at Week -4 (Visit 1) or Week -2 (Visit 2)
Exclusion criteria
* Patients with hypocalcemia or hypercalcemia (corrected serum calcium level of \< 7.0 mg/dL or \>/- 11.0 mg/dL) at Week -2 (Visit 2). * Significant renal impairments * Had acute renal failure within 3 months of Run-in period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline in serum phosphate concentrations | Week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Achievement of target serum phosphate level (2.7 to 4.6 mg/dL) | Week 0, Week 2, Week 4, Week 6, Week 8 |
| Change in serum Calcium x Phosphor product | Week 0, Week 2, Week 4, Week 6, Week 8 |
| Serum intact PTH level | Week 0, Week 2, Week 4, Week 6, Week 8 |
| Phosphate excretion in urine | Week 0, Week 4, Week 8 |
Countries
Japan
Outcome results
None listed