Study in Chronic Kidney Disease (CKD) Not on Dialysis

Bayer

Status and phase: Completed; Phase 3

Conditions: Hyperphosphatemia

Treatments: Drug: Fosrenol (Lanthanum Carbonate, BAY77-1931); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01110629

14817

Details and patient eligibility

About

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.

Enrollment: 143 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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143 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Fosrenol (Lanthanum Carbonate, BAY77-1931)

Arm 2

Placebo Comparator group

Treatment:

Drug: Placebo