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Study in Chronic Kidney Disease (CKD) Not on Dialysis

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ClinicalTrials.gov Identifier: NCT01110629
Recruitment Status : Completed
First Posted : April 26, 2010
Last Update Posted : October 15, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : June 2010
Primary Completion Date : November 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. The change from baseline in serum phosphate concentrations [ Time Frame: Week 8 ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01110629


Locations
Japan
Anjo, Aichi, Japan, 446-8602
Nagoya, Aichi, Japan, 455-8530
Nagoya, Aichi, Japan, 457-8510
Nagoya, Aichi, Japan, 460-0001
Nagoya, Aichi, Japan, 466-8650
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, 802-8555
Kitakyushu, Fukuoka, Japan, 805-0050
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, 530-0012
Osaka, Japan, 530-8480
Osaka, Japan, 534-0021
Osaka, Japan, 558-8558
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01110629     History of Changes
Other Study ID Numbers: 14817
First Posted: April 26, 2010    Key Record Dates
Last Update Posted: October 15, 2014
Last Verified: October 2014

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

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