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Phase III Double-blind Comparative Study of BAY77-1931 (Lanthanum Carbonate) With Calcium Carbonate

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01514851
First received: January 18, 2012
Last updated: June 7, 2012
Last verified: June 2012
History of Changes
  Purpose

To assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (Lanthanum Carbonate) in patients with hyperphosphatemia undergoing hemodialysis in a randomized, double-blind, parallel group study in comparison with Calcium carbonate.


Condition Intervention Phase
Hyperphosphatemia
 Drug: Lanthanum carbonate (BAY77-1931)
Drug: Calcium carbonate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Double-blind Comparative Study of BAY 77 1931 (Lanthanum Carbonate) With a Calcium Carbonate in Patients With Hyperphosphatemia Undergoing Hemodialysis

Resource links provided by NLM:

MedlinePlus related topics: Calcium Dialysis
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Change from baseline in pre-dialysis serum phosphate levels (PSPL) at the end of the double-blind period [ Time Frame: baseline to week 8 ] [ Designated as safety issue: No ]
  • Presence/absence of incidence of hypercalcemia up to 8 weeks [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants achieving target PSPL and time to achievement [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
  • Serum calcium x phosphate product at the end of the double-blind treatment period [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Serum intact-PTH (Parathyroid) levels [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Serum calcium level corrected by serum albumin level at the end of the double-blind treatment period [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Number of participants achieving the target serum calcium levels [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Safety variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 259
Study Start Date: January 2006
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
750-2250mg/day, tid (three times a day), 8 weeks
 Drug: Lanthanum carbonate (BAY77-1931)
Active Comparator: Arm 2
1500-4500mg/day, tid, 8 weeks
 Drug: Calcium carbonate

  Eligibility

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

Inclusion Criteria:

  • Pre-dialysis serum phosphate levels: ≧5.6 mg/dL and <11.0 mg/dL at 1 week after the initiation of the washout period.
  • Out-patient
  • Undergoing hemodialysis three times per week for at least previous 3 consecutive months

Exclusion Criteria:

  • Pre-dialysis serum phosphate levels of ≧10.0 mg/dL at the start of the washout period or ≧11.0 mg/dL at 1 week after
  • Corrected serum calcium level of <7.0 mg/dL or ≧11.0 mg/dL at the start of the washout period and/or 1 week after
  • Serum intact PTH (Parathyroid) of ≧1000 pg/mL at the start of the washout period
  • Pregnant woman, or lactating mother
  • Significant gastrointestinal disorders including known acute peptic ulcer
  • Liver dysfunction
  • History of cardiovascular or cerebrovascular diseases
  • Requiring treatment for hypothyroidism
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514851

Locations
Japan
Toyohashi, Aichi, Japan, 441-8023
Yatomi, Aichi, Japan, 498-0006
Asahi, Chiba, Japan, 289-2511
Kashiwa, Chiba, Japan, 277-0084
Matsudo, Chiba, Japan, 271-0077
Narita, Chiba, Japan, 286-0041
Kurume, Fukuoka, Japan, 830-8543
Kurume, Fukuoka, Japan, 830-8522
Isesaki, Gunma, Japan, 379-2211
Kobe, Hyogo, Japan, 658-0084
Mito, Ibaraki, Japan, 310-0844
Tsuchiura, Ibaraki, Japan, 300-0053
Takamatsu, Kagawa, Japan, 761-8024
Osaki, Miyagi, Japan, 989-6117
Sendai, Miyagi, Japan, 981-0912
Suita, Osaka, Japan, 564-0053
Fuji, Shizuoka, Japan, 417-0056
Hamamatsu, Shizuoka, Japan, 430-0903
Arakawa-ku, Tokyo, Japan, 116-0003
Kodaira, Tokyo, Japan, 187-0001
Nerima-ku, Tokyo, Japan, 176-0023
Shibuya-ku, Tokyo, Japan, 151-0053
Shinjyuku-ku, Tokyo, Japan, 160-0023
Chiba, Japan, 261-0011
Hiroshima, Japan, 730-0811
Kochi, Japan, 780-0066
Okayama, Japan, 701-0202
Saitama, Japan, 330-0856
Saitama, Japan, 337-0043
Saitama, Japan, 330-0854
Tokushima, Japan, 770-0011
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Head Medical Development Japan, Bayer Yakuhin Ltd.
ClinicalTrials.gov Identifier: NCT01514851     History of Changes
Other Study ID Numbers: 11877
Study First Received: January 18, 2012
Last Updated: June 7, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
Hyperphosphatemia in ESRD (End Stage Renal Disease) patients on dialysis

Additional relevant MeSH terms:
Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases
Calcium, Dietary
Calcium Carbonate
 Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013