Study in Chronic Kidney Disease (CKD) Not on Dialysis

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperphosphatemia
• Intervention / Treatment: Drug: Fosrenol (Lanthanum Carbonate, BAY77-1931); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 810-8563
  • Fukuoka, Japan, 814-0180
  • Kyoto, Japan, 612-8555
  • Oita, Japan, 870-0263
  • Okayama, Japan, 700-0013
  • Osaka, Japan, 530-8480
  • Osaka, Japan, 558-8558
  • Osaka, Japan, 534-0021
  • Osaka, Japan, 530-0012
  • Saga, Japan, 840-0054
  • Shizuoka, Japan, 421-0193
  • Tokushima, Japan, 770-0011
  • Wakayama, Japan, 641-8510
  • Aichi
    • 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
  • Chiba
    • Kamogawa, Chiba, Japan, 296-0041
    • Kisarazu, Chiba, Japan, 292-8535
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan, 802-8555
    • Kitakyushu, Fukuoka, Japan, 805-0050
    • Koga, Fukuoka, Japan, 811-3195
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 063-0005
  • Hyogo
    • Amagasaki, Hyogo, Japan, 660-0828
  • Kanagawa
    • Fujisawa, Kanagawa, Japan, 251-8550
    • Kamakura, Kanagawa, Japan, 247-8533
    • Yokohama, Kanagawa, Japan, 231-8682
    • Yokohama, Kanagawa, Japan, 234-8503
  • Oita
    • Beppu, Oita, Japan, 874-0011
  • Okayama
    • Kurashiki, Okayama, Japan, 710-8602
  • Osaka
    • Sakai, Osaka, Japan, 591-8025
  • Tokyo
    • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The change from baseline in serum phosphate concentrations	Week 8

Secondary Outcome Measures

Outcome Measure	Time Frame
Achievement of target serum phosphate level (2.7 to 4.6 mg/dL)	Week 0, Week 2, Week 4, Week 6, Week 8
Change in serum Calcium x Phosphor product	Week 0, Week 2, Week 4, Week 6, Week 8
Serum intact PTH level	Week 0, Week 2, Week 4, Week 6, Week 8
Phosphate excretion in urine	Week 0, Week 4, Week 8

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Shire

Publications and helpful links

General Publications

• Takahara Y, Matsuda Y, Takahashi S, Shigematsu T; Lanthanum Carbonate Study Group. Efficacy and safety of lanthanum carbonate in pre-dialysis CKD patients with hyperphosphatemia: a randomized trial. Clin Nephrol. 2014 Sep;82(3):181-90. doi: 10.5414/cn108269.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (ACTUAL): November 1, 2011
• Study Completion (ACTUAL): November 1, 2011

Study Registration Dates

• First Submitted: April 23, 2010
• First Submitted That Met QC Criteria: April 23, 2010
• First Posted (ESTIMATE): April 26, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 15, 2014
• Last Update Submitted That Met QC Criteria: October 12, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Chronic kidney disease not on dialysis; Lanthanum carbonate
• Additional Relevant MeSH Terms: Metabolic Diseases; Urologic Diseases; Renal Insufficiency; Phosphorus Metabolism Disorders; Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia
• Other Study ID Numbers: 14817