We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04899661
Previous Study | Return to List | Next Study

A Study to Learn More About the Long-term Safety and Effectiveness of Molidustat as a Treatment for Japanese Men and Women With Renal Anemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04899661
Recruitment Status : Recruiting
First Posted : May 24, 2021
Last Update Posted : March 20, 2023
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

In this study, the researchers want to learn more about the safety and effectiveness of Molidustat in Japanese men and women who have renal anemia, a condition in which the kidneys do not make enough of a hormone that helps the body make new red blood cells.

In previous clinical trials with a small number of participants, several important adverse events were observed. The researchers in this study want to know how many patients also have these adverse events under the real world, and if the number of the red blood cells will be increased after the treatment of Molidustat.

The researchers will collect the participants' health information from their medical records and their regular check-ups for up to 2 years. The data from this study will be submitted to the health authority in Japan in accordance with the local regulation.


Condition or disease Intervention/treatment
Renal Anemia Drug: Molidustat (Musredo, BAY85-3934)

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Special Drug Use Investigation of Molidustat for Patients With Renal Anemia
Actual Study Start Date : August 6, 2021
Estimated Primary Completion Date : June 30, 2027
Estimated Study Completion Date : September 30, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Molidustat
Participants diagnosed with renal anemia treated with Molidustat at the discretion of investigators
 Drug: Molidustat (Musredo, BAY85-3934)
Tablets, administered orally at the discretion of investigators


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incidence of safety events [ Time Frame: Up to approximately 24 months ]
    Adverse Events/Adverse Drug Reactions including thromboembolism, hypertension, malignant tumor retinal hemorrhage, Major Adverse Cardiovascular Events (MACE) without thromboembolism, Interstitial lung disease (ILD) and Progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD) in renal anemia patients


Secondary Outcome Measures :
  1. Incidence of safety events in dialysis and non-dialysis participants [ Time Frame: Up to approximately 24 months ]
    Adverse Events/Adverse Drug Reactions including thromboembolism, hypertension, malignant tumor retinal hemorrhage, Major Adverse Cardiovascular Events (MACE) without thromboembolism, Interstitial lung disease(ILD) and Progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD) in renal anemia patients

  2. Incidence of safety events (important identified risk and important potential risk) by patient background [ Time Frame: Up to approximately 24 months ]

    Important identified risk: "Thromboembolism" and "Hypertension"

    Important potential risk:

    "Malignant tumor", "Retinal hemorrhage", "Major Adverse Cardiovascular Events (MACE) without thromboembolism", "Interstitial lung disease(ILD)" and "Progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD)"


  3. Absolute changes of Hemoglobin (Hb) levels from the baseline [ Time Frame: Up to approximately 24 months ]
  4. Percentage changes of Hemoglobin (Hb) levels from the baseline [ Time Frame: Up to approximately 24 months ]
  5. Absolute changes of Hb levels from baseline in sub-group analysis [ Time Frame: Up to approximately 24 months ]
    By patient background

  6. Percentage changes of Hb levels from baseline in sub-group analysis [ Time Frame: Up to approximately 24 months ]
    By patient background

  7. Time course of Hb levels from the baseline [ Time Frame: Up to approximately 24 months ]
  8. Proportion of participants with Hb level within target range [ Time Frame: Up to approximately 24 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with a diagnosis of renal anemia and have been prescribed Molidustat in accordance with the product label
Criteria

Inclusion Criteria:

  • Female or male participants with a diagnosis of renal anemia
  • Decision to initiate treatment with Molidustat was made as per investigator's routine treatment practice
  • Molidustat naïve participants (with including the participants treated within three months before the contracted date at each site)
  • Signed informed consent

Exclusion Criteria:

- Contra-indications according to the local marketing authorization

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04899661


Contacts
Layout table for location contacts
Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Locations
Layout table for location information
Japan
Many facilities Recruiting
Multiple Locations, Japan
Sponsors and Collaborators
Bayer
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04899661    
Other Study ID Numbers: 21319
First Posted: May 24, 2021    Key Record Dates
Last Update Posted: March 20, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia
Hematologic Diseases