Trial Condition(s):

Hyperphosphatemia

Open study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis Patients

Bayer Identifier:

11878

ClinicalTrials.gov Identifier:

NCT01518387

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The purpose of this study is to assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (lanthanum carbonate) in patients with hyperphosphatemia undergoing continuous ambulatory peritoneal dialysis.

Inclusion Criteria
- Serum phosphate levels: >5.0 mg/dL and <11.0 mg/dL 2 weeks after the initiation of the washout period
- Out-patient
- Undergoing CAPD for at least previous 3 consecutive months
Exclusion Criteria
- Who may not enable to continue CAPD
- Serum phosphate levels of >=10.0 mg/dL at the start of the washout period or >=11.0 mg/dL 2 week after
- Corrected serum calcium level of <7.0 mg/dL at the start of the washout period or >=11.0 mg/dL 2 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

Trial Summary

Enrollment Goal
43
Trial Dates
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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

Kitasaito Hospital

Asahikawa, Japan, 070-0030

Status
Completed
 
Locations

Eijinkai Hospital

Osaki, Japan, 989-6117

Status
Completed
 
Locations

Sendai Shakaihoken Hospital

Sendai, Japan, 981-0912

Status
Completed
 
Locations

Tokyo Kyosai Hospital

Meguro-ku, Japan, 153-0061

Status
Completed
 
Locations

Shonan Kamakura General Hospital

Kamakura, Japan, 247-0072

Status
Completed
 
Locations

Yokosuka Kyosai Hospital

Yokosuka, Japan, 238-0011

Status
Completed
 
Locations

Gifu Prefectural General Medical Center

Gifu, Japan, 500-8717

Status
Completed
 
Locations

Okayama Saiseikai General Hospital

Okayama, Japan, 700-0013

Status
Completed
 
Locations

Tsuchiya General Hospital

Hiroshima, Japan, 730-8655

Status
Completed
 
Locations

Kawashima Hospital

Tokushima, Japan, 770-0011

Status
Completed
 
Locations

Fukuoka Red Cross Hospital

Fukuoka, Japan, 815-0082

Status
Completed
 

Trial Design