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Long-term Study in Chronic Kidney Disease (Extension From Study 14817)

Primary Purpose

Hyperphosphatemia

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Fosrenol (Lanthanum Carbonate, BAY77-1931)

About this trial

This is an interventional treatment trial for Hyperphosphatemia focused on measuring Long-term study in Chronic Kidney Disease, Lanthanum Carbonate

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Incidence of treatment emergent adverse events

Secondary Outcome Measures

Full Information

NCT ID

NCT01187628

First Posted

August 23, 2010

Last Updated

April 2, 2015

Sponsor

Bayer

Collaborators

Shire

1. Study Identification

Unique Protocol Identification Number

NCT01187628

Brief Title

Long-term Study in Chronic Kidney Disease (Extension From Study 14817)

Official Title

An Open-label, Long-term Extension Study of Lanthanum Carbonate 750 to 2,250 mg in Hyperphosphatemia in Patients With Chronic Kidney Disease Not on Dialysis (52 Weeks Extension From Study 14817)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

Collaborators

Shire

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperphosphatemia

Keywords

Long-term study in Chronic Kidney Disease, Lanthanum Carbonate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

123 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Fosrenol (Lanthanum Carbonate, BAY77-1931)

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of treatment emergent adverse events

Time Frame

baseline to Week 60

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: Patients with any other conditions that the investigator defines as not appropriate to be enrolled in the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Anjo

State/Province

Aichi

ZIP/Postal Code

446-8602

Country

Japan

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

455-8530

Country

Japan

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

457-8510

Country

Japan

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

460-0001

Country

Japan

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

466-8650

Country

Japan

City

Seto

State/Province

Aichi

ZIP/Postal Code

489-8642

Country

Japan

City

Toyohashi

State/Province

Aichi

ZIP/Postal Code

441-8021

Country

Japan

City

Yatomi

State/Province

Aichi

ZIP/Postal Code

498-8502

Country

Japan

City

Kamogawa

State/Province

Chiba

ZIP/Postal Code

296-0041

Country

Japan

City

Kisarazu

State/Province

Chiba

ZIP/Postal Code

292-8535

Country

Japan

City

Kitakyushu

State/Province

Fukuoka

ZIP/Postal Code

802-0001

Country

Japan

City

Kitakyushu

State/Province

Fukuoka

ZIP/Postal Code

805-0050

Country

Japan

City

Koga

State/Province

Fukuoka

ZIP/Postal Code

811-3195

Country

Japan

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

063-0005

Country

Japan

City

Amagasaki

State/Province

Hyogo

ZIP/Postal Code

660-0828

Country

Japan

City

Fujisawa

State/Province

Kanagawa

ZIP/Postal Code

251-8550

Country

Japan

City

Kamakura

State/Province

Kanagawa

ZIP/Postal Code

247-8533

Country

Japan

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

231-8682

Country

Japan

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

234-8503

Country

Japan

City

Beppu

State/Province

Oita

ZIP/Postal Code

874-0011

Country

Japan

City

Kurashiki

State/Province

Okayama

ZIP/Postal Code

710-8602

Country

Japan

City

Sakai

State/Province

Osaka

ZIP/Postal Code

591-8025

Country

Japan

City

Koto

State/Province

Tokyo

ZIP/Postal Code

136-0075

Country

Japan

City

Meguro-ku

State/Province

Tokyo

ZIP/Postal Code

152-8902

Country

Japan

City

Minato-ku

State/Province

Tokyo

ZIP/Postal Code

105-8471

Country

Japan

City

Musashino

State/Province

Tokyo

ZIP/Postal Code

180-8610

Country

Japan

City

Shinagawa

State/Province

Tokyo

ZIP/Postal Code

141-8625

Country

Japan

City

Fukuoka

ZIP/Postal Code

810-8563

Country

Japan

City

Fukuoka

ZIP/Postal Code

814-0180

Country

Japan

City

Kyoto

ZIP/Postal Code

612-8555

Country

Japan

City

Oita

ZIP/Postal Code

870-0263

Country

Japan

City

Okayama

ZIP/Postal Code

700-0013

Country

Japan

City

Osaka

ZIP/Postal Code

530-0012

Country

Japan

City

Osaka

ZIP/Postal Code

530-8480

Country

Japan

City

Osaka

ZIP/Postal Code

534-0021

Country

Japan

City

Osaka

ZIP/Postal Code

558-8558

Country

Japan

City

Saga

ZIP/Postal Code

840-0054

Country

Japan

City

Shizuoka

ZIP/Postal Code

421-0193

Country

Japan

City

Tokushima

ZIP/Postal Code

770-0011

Country

Japan

City

Wakayama

ZIP/Postal Code

641-8510

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

Long-term Study in Chronic Kidney Disease (Extension From Study 14817)

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