Study in Chronic Kidney Disease (CKD) Not on Dialysis

Hyperphosphatemia Clinical Trial

Official title:

Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Lanthanum Carbonate 750 to 2250 mg in Patients With Chronic Kidney Disease Not on Dialysis Who Develop Hyperphosphatemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01110629
• Other study ID #: 14817
• Status: Completed
• Phase: Phase 3
• First received: April 23, 2010
• Last updated: October 12, 2014
• Start date: June 2010
• Est. completion date: November 2011

Study information

• Verified date: October 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperphosphatemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Fosrenol (Lanthanum Carbonate, BAY77-1931)
Daily dose: 750-2250mg 3 times a dayfor 8 weeks.
• Placebo
daily dose: 3 tablets TID for 8 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Shire

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from baseline in serum phosphate concentrations		Week 8	No
Secondary	Achievement of target serum phosphate level (2.7 to 4.6 mg/dL)		Week 0, Week 2, Week 4, Week 6, Week 8	No
Secondary	Change in serum Calcium x Phosphor product		Week 0, Week 2, Week 4, Week 6, Week 8	No
Secondary	Serum intact PTH level		Week 0, Week 2, Week 4, Week 6, Week 8	No
Secondary	Phosphate excretion in urine		Week 0, Week 4, Week 8	No

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