NCT01187628

Brief Summary

The objective of this study is to investigate the safety and the effect on reduction of serum phosphate of long-term administration of lanthanum carbonate (BAY77-1931) 750 to 2250 mg in patients with hyperphosphatemia who completed the 8 week double-blind treatment period of Study 14817 and are judged to be eligible for the long-term extension study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2010

Typical duration for phase_3

Geographic Reach
1 country

40 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2010

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 3, 2015

Status Verified

April 1, 2015

Enrollment Period

2.6 years

First QC Date

August 23, 2010

Last Update Submit

April 2, 2015

Conditions

Hyperphosphatemia

Keywords

Long-term study in Chronic Kidney DiseaseLanthanum Carbonate

Outcome Measures

Primary Outcomes (1)

  • Incidence of treatment emergent adverse events

    baseline to Week 60

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Fosrenol (Lanthanum Carbonate, BAY77-1931)

Interventions

Fosrenol (Lanthanum Carbonate, BAY77-1931)DRUG

Daily dose: 750-2250mg/day,(270-750mg each 3 times a day) for 52 weeks.

Arm 1

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have completed the 8-week double-blind treatment period of Study 14817 and are judged to be eligible for the long-term extension study by the investigator (including those who plan to be on dialysis during the long-term extension study).

You may not qualify if:

  • Patients with any other conditions that the investigator defines as not appropriate to be enrolled in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (40)

Unknown Facility

Anjo, Aichi-ken, 446-8602, Japan

Location

Unknown Facility

Nagoya, Aichi-ken, 455-8530, Japan

Location

Unknown Facility

Nagoya, Aichi-ken, 457-8510, Japan

Location

Unknown Facility

Nagoya, Aichi-ken, 460-0001, Japan

Location

Unknown Facility

Nagoya, Aichi-ken, 466-8650, Japan

Location

Unknown Facility

Seto, Aichi-ken, 489-8642, Japan

Location

Unknown Facility

Toyohashi, Aichi-ken, 441-8021, Japan

Location

Unknown Facility

Yatomi, Aichi-ken, 498-8502, Japan

Location

Unknown Facility

Kamogawa, Chiba, 296-0041, Japan

Location

Unknown Facility

Kisarazu, Chiba, 292-8535, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, 810-8563, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, 814-0180, Japan

Location

Unknown Facility

Kitakyushu, Fukuoka, 802-0001, Japan

Location

Unknown Facility

Kitakyushu, Fukuoka, 805-0050, Japan

Location

Unknown Facility

Koga, Fukuoka, 811-3195, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 063-0005, Japan

Location

Unknown Facility

Amagasaki, Hyōgo, 660-0828, Japan

Location

Unknown Facility

Fujisawa, Kanagawa, 251-8550, Japan

Location

Unknown Facility

Kamakura, Kanagawa, 247-8533, Japan

Location

Unknown Facility

Yokohama, Kanagawa, 231-8682, Japan

Location

Unknown Facility

Yokohama, Kanagawa, 234-8503, Japan

Location

Unknown Facility

Kyoto, Kyoto, 612-8555, Japan

Location

Unknown Facility

Beppu, Oita Prefecture, 874-0011, Japan

Location

Unknown Facility

Ōita, Oita Prefecture, 870-0263, Japan

Location

Unknown Facility

Kurashiki, Okayama-ken, 710-8602, Japan

Location

Unknown Facility

Okayama, Okayama-ken, 700-0013, Japan

Location

Unknown Facility

Osaka, Osaka, 530-0012, Japan

Location

Unknown Facility

Osaka, Osaka, 530-8480, Japan

Location

Unknown Facility

Osaka, Osaka, 534-0021, Japan

Location

Unknown Facility

Osaka, Osaka, 558-8558, Japan

Location

Unknown Facility

Sakai, Osaka, 591-8025, Japan

Location

Unknown Facility

Saga, Saga-ken, 840-0054, Japan

Location

Unknown Facility

Shizuoka, Shizuoka, 421-0193, Japan

Location

Unknown Facility

Tokushima, Tokushima, 770-0011, Japan

Location

Unknown Facility

Koto, Tokyo, 136-0075, Japan

Location

Unknown Facility

Meguro-ku, Tokyo, 152-8902, Japan

Location

Unknown Facility

Minato-ku, Tokyo, 105-8471, Japan

Location

Unknown Facility

Musashino, Tokyo, 180-8610, Japan

Location

Unknown Facility

Shinagawa, Tokyo, 141-8625, Japan

Location

Unknown Facility

Wakayama, Wakayama, 641-8510, Japan

Location

MeSH Terms

Conditions

Hyperphosphatemia

Interventions

lanthanum carbonate

Condition Hierarchy (Ancestors)

Phosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2010

First Posted

August 24, 2010

Study Start

September 1, 2010

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

April 3, 2015

Record last verified: 2015-04

Locations

JP(40)