Study in Chronic Kidney Disease (CKD) Not on Dialysis

This study has been completed.
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01110629
First received: April 23, 2010
Last updated: October 12, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Hyperphosphatemia
Drug: Fosrenol (Lanthanum Carbonate, BAY77-1931)
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • The change from baseline in serum phosphate concentrations [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Change in serum Calcium x Phosphor product [ Time Frame: Week 0, Week 2, Week 4, Week 6, Week 8 ] [ Designated as safety issue: No ]
  • Serum intact PTH level [ Time Frame: Week 0, Week 2, Week 4, Week 6, Week 8 ] [ Designated as safety issue: No ]
  • Phosphate excretion in urine [ Time Frame: Week 0, Week 4, Week 8 ] [ Designated as safety issue: No ]

Enrollment: 143
Study Start Date: June 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Fosrenol (Lanthanum Carbonate, BAY77-1931)
Daily dose: 750-2250mg 3 times a dayfor 8 weeks.
Placebo Comparator: Arm 2 Drug: Placebo
daily dose: 3 tablets TID for 8 weeks.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01110629

Locations
Japan
Anjo, Aichi, Japan, 446-8602
Nagoya, Aichi, Japan, 455-8530
Nagoya, Aichi, Japan, 460-0001
Nagoya, Aichi, Japan, 466-8650
Nagoya, Aichi, Japan, 457-8510
Seto, Aichi, Japan, 489-8642
Toyohashi, Aichi, Japan, 441-8021
Yatomi, Aichi, Japan, 498-8502
Kamogawa, Chiba, Japan, 296-0041
Kisarazu, Chiba, Japan, 292-8535
Kitakyushu, Fukuoka, Japan, 805-0050
Kitakyushu, Fukuoka, Japan, 802-8555
Koga, Fukuoka, Japan, 811-3195
Sapporo, Hokkaido, Japan, 063-0005
Amagasaki, Hyogo, Japan, 660-0828
Fujisawa, Kanagawa, Japan, 251-8550
Kamakura, Kanagawa, Japan, 247-8533
Yokohama, Kanagawa, Japan, 231-8682
Yokohama, Kanagawa, Japan, 234-8503
Beppu, Oita, Japan, 874-0011
Kurashiki, Okayama, Japan, 710-8602
Sakai, Osaka, Japan, 591-8025
Koto, Tokyo, Japan, 136-0075
Meguro-ku, Tokyo, Japan, 152-8902
Minato-ku, Tokyo, Japan, 105-8471
Musashino, Tokyo, Japan, 180-8610
Shinagawa, Tokyo, Japan, 141-8625
Fukuoka, Japan, 810-8563
Fukuoka, Japan, 814-0180
Kyoto, Japan, 612-8555
Oita, Japan, 870-0263
Okayama, Japan, 700-0013
Osaka, Japan, 534-0021
Osaka, Japan, 530-0012
Osaka, Japan, 558-8558
Osaka, Japan, 530-8480
Saga, Japan, 840-0054
Shizuoka, Japan, 421-0193
Tokushima, Japan, 770-0011
Wakayama, Japan, 641-8510
Sponsors and Collaborators
Bayer
Shire
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01110629     History of Changes
Other Study ID Numbers: 14817
Study First Received: April 23, 2010
Last Updated: October 12, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
Chronic kidney disease not on dialysis
Lanthanum carbonate

Additional relevant MeSH terms:
Kidney Diseases
Hyperphosphatemia
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on April 20, 2014