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Completed

NCT Number: NCT01110629

Study in Chronic Kidney Disease (CKD) Not on Dialysis

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.

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Key information

Conditions

Hyperphosphatemia Metabolic Diseases Nutritional and Metabolic Diseases Phosphorus Metabolism Disorders

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Anjo, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fosrenol (Lanthanum Carbonate, BAY77-1931)

Drug

Daily dose: 750-2250mg 3 times a dayfor 8 weeks.

Placebo

Drug

daily dose: 3 tablets TID for 8 weeks.

Primary outcomes

  1. The change from baseline in serum phosphate concentrations

    Time frame: Week 8

Secondary outcomes

  1. Achievement of target serum phosphate level (2.7 to 4.6 mg/dL)

    Time frame: Week 0, Week 2, Week 4, Week 6, Week 8

  2. Change in serum Calcium x Phosphor product

    Time frame: Week 0, Week 2, Week 4, Week 6, Week 8

  3. Serum intact PTH level

    Time frame: Week 0, Week 2, Week 4, Week 6, Week 8

  4. Phosphate excretion in urine

    Time frame: Week 0, Week 4, Week 8

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Shire

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 26, 2010
Registry last updated
Oct 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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