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

NCT01514851 | Completed Phase 3

• 1 other identifier: 11877
• Study Type: interventional
• Target: 259
• Locations: 1 country
• Sites: 31

Brief Summary

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.

Conditions

Hyperphosphatemia

Keywords

Hyperphosphatemia in ESRD (End Stage Renal Disease) patients on dialysis

Outcome Measures

Primary Outcomes (2)

• Change from baseline in pre-dialysis serum phosphate levels (PSPL) at the end of the double-blind period

  baseline to week 8

• Presence/absence of incidence of hypercalcemia up to 8 weeks

  up to 8 weeks

Secondary Outcomes (6)

• Number of participants achieving target PSPL and time to achievement

  up to 8 weeks

• Serum calcium x phosphate product at the end of the double-blind treatment period

  Week 8

• Serum intact-PTH (Parathyroid) levels

  Week 8

• Serum calcium level corrected by serum albumin level at the end of the double-blind treatment period

  Week 8

• Number of participants achieving the target serum calcium levels

  Week 8

Study Arms (2)

Arm 1

EXPERIMENTAL

750-2250mg/day, tid (three times a day), 8 weeks

Drug: Lanthanum carbonate (BAY77-1931)

Arm 2

ACTIVE COMPARATOR

1500-4500mg/day, tid, 8 weeks

Drug: Calcium carbonate

Interventions

Lanthanum carbonate (BAY77-1931) DRUG

Arm 1

Calcium carbonate DRUG

Arm 2

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (31)

Unknown Facility

Toyohashi, Aichi-ken, 441-8023, Japan

Location

Unknown Facility

Yatomi, Aichi-ken, 498-0006, Japan

Location

Unknown Facility

Asahi, Chiba, 289-2511, Japan

Location

Unknown Facility

Chiba, Chiba, 261-0011, Japan

Location

Unknown Facility

Kashiwa, Chiba, 277-0084, Japan

Location

Unknown Facility

Matsudo, Chiba, 271-0077, Japan

Location

Unknown Facility

Narita, Chiba, 286-0041, Japan

Location

Unknown Facility

Kurume, Fukuoka, 830-8522, Japan

Location

Unknown Facility

Kurume, Fukuoka, 830-8543, Japan

Location

Unknown Facility

Isesaki, Gunma, 379-2211, Japan

Location

Unknown Facility

Hiroshima, Hiroshima, 730-0811, Japan

Location

Unknown Facility

Kobe, Hyōgo, 658-0084, Japan

Location

Unknown Facility

Mito, Ibaraki, 310-0844, Japan

Location

Unknown Facility

Tsuchiura, Ibaraki, 300-0053, Japan

Location

Unknown Facility

Takamatsu, Kagawa-ken, 761-8024, Japan

Location

Unknown Facility

Kochi, Kochi, 780-0066, Japan

Location

Unknown Facility

Ōsaki, Miyagi, 989-6117, Japan

Location

Unknown Facility

Sendai, Miyagi, 981-0912, Japan

Location

Unknown Facility

Okayama, Okayama-ken, 701-0202, Japan

Location

Unknown Facility

Suita, Osaka, 564-0053, Japan

Location

Unknown Facility

Saitama, Saitama, 330-0854, Japan

Location

Unknown Facility

Saitama, Saitama, 330-0856, Japan

Location

Unknown Facility

Saitama, Saitama, 337-0043, Japan

Location

Unknown Facility

Fuji, Shizuoka, 417-0056, Japan

Location

Unknown Facility

Hamamatsu, Shizuoka, 430-0903, Japan

Location

Unknown Facility

Tokushima, Tokushima, 770-0011, Japan

Location

Unknown Facility

Arakawa-ku, Tokyo, 116-0003, Japan

Location

Unknown Facility

Kodaira, Tokyo, 187-0001, Japan

Location

Unknown Facility

Nerima-ku, Tokyo, 176-0023, Japan

Location

Unknown Facility

Shibuya-ku, Tokyo, 151-0053, Japan

Location

Unknown Facility

Shinjyuku-ku, Tokyo, 160-0023, Japan

Location

MeSH Terms

Conditions

Hyperphosphatemia; Kidney Failure, Chronic

Interventions

lanthanum carbonate; Calcium Carbonate

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 18, 2012
• First Posted: January 23, 2012
• Study Start: January 1, 2006
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: June 8, 2012

Record last verified: 2012-06

Locations

JP (31)