Trial Condition(s):

Hyperphosphatemia

Phase III double-blind comparative study of BAY77-1931 (Lanthanum Carbonate) with Calcium carbonate

Bayer Identifier:

11877

ClinicalTrials.gov Identifier:

NCT01514851

EudraCT Number:

Not Available

Study Completed

Trial 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.

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

Trial Summary

Enrollment Goal
259
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Fosrenol (Lanthanum Carbonate, BAY77-1931)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Mihama Hospital

Chiba, Japan, 261-0011

Status
Completed
 
Locations

Mihama Narita Clinic

Narita, Japan, 286-0041

Status
Completed
 
Locations

Shin Kashiwa Clinic

Kashiwa, Japan, 277-0084

Status
Completed
 
Locations

Sendai Shakaihoken Hospital

Sendai, Japan, 981-0912

Status
Completed
 
Locations

Meiyo Clinic

Toyohashi, Japan, 441-8023

Status
Completed
 
Locations

Ama Kyoritsu Clinic

Yatomi, Japan, 498-0006

Status
Completed
 
Locations

Shigei Medical Research Hospital

Okayama, Japan, 701-0202

Status
Completed
 
Locations

Nakajima Tsuchiya Clinic

Hiroshima, Japan, 730-0811

Status
Completed
 
Locations

Kawashima Hospital

Tokushima, Japan, 770-0011

Status
Completed
 
Locations

Kinashi-Obayashi Hospital

Takamatsu, Japan, 761-8024

Status
Completed
 
Locations

Shimazu Hospital

Kochi, Japan, 780-0066

Status
Completed
 
Locations

Tokai Hospital

Nerima-ku, Japan, 176-0023

Status
Completed
 
Locations

Maruyama Hospital

Hamamatsu, Japan, 430-0903

Status
Completed
 
Locations

Inoue Hospital

Suita, Japan, 564-0053

Status
Completed
 
Locations

Seseragi Hospital

Isesaki, Japan, 379-2211

Status
Completed
 
Locations

Eijinkai Hospital

Osaki, Japan, 989-6117

Status
Completed
 
Locations

Yuai Clinic

Saitama, Japan, 330-0854

Status
Completed
 
Locations

Yuai Nakagawa Clinic

Saitama, Japan, 337-0043

Status
Completed
 
Locations

Yuai Mihashi Clinic

Saitama, Japan, 330-0856

Status
Completed
 
Locations

Sumiyoshi Clinic Hospital

Mito, Japan, 310-0844

Status
Completed
 
Locations

Tsuchiurakyodo General Hospital

Tsuchiura, Japan, 300-0053

Status
Completed
 
Locations

Tokatsu Clinic Matsudo

Matsudo, Japan, 271-0077

Status
Completed
 
Locations

Asahi Central Hospital

Asahi, Japan, 289-2511

Status
Completed
 
Locations

Minami-senju Hospital

Arakawa-ku, Japan, 116-0003

Status
Completed
 
Locations

Shinjuku Koshin Clinic

Shinjyuku-ku, Japan, 160-0023

Status
Completed
 
Locations

Bosei Shinjuku South Clinic

Shibuya-ku, Japan, 151-0053

Status
Completed
 
Locations

Kodaira North Clinic

Kodaira, Japan, 187-0001

Status
Completed
 
Locations

Fuji First Clinic

Fuji, Japan, 417-0056

Status
Completed
 
Locations

Sumiyoshigawa Hospital

Kobe, Japan, 658-0084

Status
Completed
 
Locations

St.Mary's Hospital

Kurume, Japan, 830-8543

Status
Completed
 
Locations

Koga Clinic

Kurume, Japan, 830-8522

Status
Completed
 

Trial Design