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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014