MedDataX Logo

BAY 77-1931 Long-term Extension From Phase II Study

NCT ID: NCT00769496

Last Updated: 2013-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A long-term study of BAY77-1931 (lanthanum carbonate) for hyperphosphatemia in patients undergoing hemodialysis

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01518387

Hyperphosphatemia
COMPLETED PHASE3

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

NCT01514851

Hyperphosphatemia
COMPLETED PHASE3

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

NCT01187628

Hyperphosphatemia
COMPLETED PHASE3

Study in Chronic Kidney Disease (CKD) Not on Dialysis

NCT01110629

Hyperphosphatemia
COMPLETED PHASE3

Clinical Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

NCT04767581

Hyperphosphatemia
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperphosphatemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

Group Type EXPERIMENTAL

BAY 77-1931

Intervention Type DRUG

Lanthanum Carbonate (BAY 77-1931)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BAY 77-1931

Lanthanum Carbonate (BAY 77-1931)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Undergoing hemodialysis 3 times per week for chronic renal failure for the previous 3 consecutive months at least

Exclusion Criteria

* Pre-dialysis serum phosphate levels of 10.0mg/dL during the washout period
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bayer Yakuhin Ltd.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Toyohashi, Aichi-ken, Japan

Site Status

Yatomi, Aichi-ken, Japan

Site Status

Chiba, Chiba, Japan

Site Status

Kashiwa, Chiba, Japan

Site Status

Narita, Chiba, Japan

Site Status

Sakura, Chiba, Japan

Site Status

Hiroshima, Hiroshima, Japan

Site Status

Asahikawa, Hokkaido, Japan

Site Status

Kochi, Kochi, Japan

Site Status

Kochi, Kochi, Japan

Site Status

Kochi, Kochi, Japan

Site Status

Okayama, Okayama-ken, Japan

Site Status

Suita, Osaka, Japan

Site Status

Tokushima, Tokushima, Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

11551

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Phosphate Binder-combination Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
NCT04766398 COMPLETED PHASE3
Dose-finding Study of KHK7791 in Hyperphosphatemia Patients
NCT03864458 COMPLETED PHASE2
Phosphate Binder-combination Study of KHK7791 in Hyperphosphatemia Patients
NCT03864445 COMPLETED PHASE2
Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
NCT04771780 COMPLETED PHASE3
Fosrenol Post-marketing Surveillance for Hemodialysis in Japan
NCT01419327 COMPLETED
Clinical Study of KHK7791 in Hyperphosphatemia Patients on Peritoneal Dialysis
NCT04766385 COMPLETED PHASE3
A Long-term Study of PA21 in Hemodialysis Patients With Hyperphosphatemia
NCT01833494 COMPLETED PHASE3
A Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on HD
NCT03831607 COMPLETED PHASE2
Fosrenol Post-marketing Surveillance for Continuous Cyclic Peritoneal Dialysis in Japan
NCT01412398 COMPLETED
Study to Learn More About the Effect of a New Drug Called BAY2327949 on the Blood Flow Through Kidneys in Adult Participants With Moderate Chronic Kidney Disease
NCT04552262 TERMINATED PHASE1
Study to Assess the Safety, Tolerability, Effects on the Body, Absorption, Distribution and Elimination of 25 mg BAY2433334 in Renal Impairment Including Renal Replacement Therapy ("Dialysis")
NCT04510987 COMPLETED PHASE1
A Study to Learn About How Well BAY3283142 Works and Its Safety in Participants With Chronic Kidney Disease
NCT06522997 ACTIVE_NOT_RECRUITING PHASE2
Efficacy and Tolerability of ILY101 in Dialysis Patients With Hyperphosphatemia
NCT00358046 UNKNOWN PHASE2
A Study to Evaluate the Pharmacokinetics (How it Moves Into, Through and Out From the Body) of a New Gadolinium-based Contrast Agent (GBCA) After Injection and How Safe it is in Participants With Normal and Impaired Renal Function
NCT05061979 COMPLETED PHASE1
Efficacy and Safety of Lanthanum in Controlling Serum Phosphate Levels in Subjects With End Stage Renal Disease Who Require Treatment for High Levels of Phosphate in Their Blood
NCT00150566 COMPLETED PHASE3
A Phase1 Study to Explore the Safety of EOS789 in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis
NCT02965053 COMPLETED PHASE1
Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
NCT00772382 COMPLETED PHASE3
A Study to Learn How the Study Treatment BAY3283142 Taken as Single Dose by Mouth Moves Into, Through, and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Reduced Kidney Function Compared to Participants With Normal Kidney Function of Similar Age, Gender, and Weight
NCT05515432 COMPLETED PHASE1
A Clinical Study to Evaluate the Safety, Tolerability and Activity of a New Phosphate Binder (SBR759) in Patients With Chronic Kidney Disease on Hemodialysis
NCT00750295 COMPLETED PHASE1/PHASE2
Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients
NCT01069692 COMPLETED PHASE3
An Efficacy and Safety Study of Sevelamer Carbonate in Hyperphosphatemic Pediatric Participants With Chronic Kidney Disease
NCT01574326 COMPLETED PHASE2
A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia
NCT00506441 COMPLETED PHASE3
Fosrenol Post-marketing Surveillance in Japan
NCT01955876 COMPLETED
End-stage Renal Disease (ESRD) Pilot Study
NCT03787368 COMPLETED PHASE1
Efficacy and Tolerability of Treatment With Lanthanum Carbonate in Patients With End Stage Renal Disease Receiving Dialysis
NCT00151931 COMPLETED PHASE3