Phase 2 Study of TMX-049 in Subjects With Type 2 Diabetes and Albuminuria

August 1, 2022 updated by: Teijin America, Inc.

A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 2 Study to Assess Safety, Tolerability, and Renal Effects of TMX-049 in Subjects With Type 2 Diabetes and Albuminuria

The primary objective of this study is to assess the effect of 2 dose levels of TMX-049 on urinary albumin excretion in subjects with Type 2 diabetes and albuminuria (a urinary albumin-to-creatinine ratio (UACR) 200 to 3000 mg/g and an estimated glomerular filtration rate (eGFR) ≥30 ml/min/1.73m2). Effects of each TMX-049 dose on UACR will be assessed in terms of ratios using log-transformed UACR at Baseline and after a 12-week period of treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Flagstaff, Arizona, United States, 86001
        • AKDHC Medical Research Services, LLC
      • Mesa, Arizona, United States, 85210
        • Aventiv Research Inc.
    • California
      • Alhambra, California, United States, 91801
        • Comprehensive Research Institute
      • Covina, California, United States, 91723
        • California Kidney Specialists
      • Lomita, California, United States, 90717
        • Torrance Clinical Research Institute, Inc.
      • Northridge, California, United States, 91325
        • Valley Clinical Trials, Inc.
      • Orange, California, United States, 92868
        • Diabetes Associates Medical Group
      • Palm Springs, California, United States, 92262
        • Desert Oasis Healthcare Medical Group
      • San Dimas, California, United States, 91773
        • California Kidney Specialists
      • San Dimas, California, United States, 91773
        • North America Research Institute
    • Florida
      • Miami, Florida, United States, 33015
        • Leon Medical Research
      • Miami Lakes, Florida, United States, 33014
        • San Marcus Research Clinic, Inc.
      • Ocoee, Florida, United States, 34761
        • Endocrine Associates of Florida, P.A.
      • Pembroke Pines, Florida, United States, 33026
        • Pines Care Research Center
      • Port Charlotte, Florida, United States, 33952
        • Hanson Clinical Research Center
    • Georgia
      • Augusta, Georgia, United States, 30901
        • Nephrology Associates, PC
      • Augusta, Georgia, United States, 30909
        • Southeastern Clinical Research Institute
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East-West Medical Research Institute
    • Idaho
      • Meridian, Idaho, United States, 83646
        • Solaris Clinical Research, Llc
    • Illinois
      • Elgin, Illinois, United States, 60124
        • Associate in Endocrinology
    • Indiana
      • Anderson, Indiana, United States, 46011
        • Community Clinical Research Center
      • Anderson, Indiana, United States, 46011
        • Community Hospital of Anderson and Madison County, Inc.
    • Iowa
      • Des Moines, Iowa, United States, 50265
        • Iowa Kidney Physicians
      • West Des Moines, Iowa, United States, 50265
        • Iowa Diabetes and Endocrinology Research Center
    • Kansas
      • Manhattan, Kansas, United States, 66502
        • My Kidney Center, LLC.
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Clinical Research Center
    • Kentucky
      • Paducah, Kentucky, United States, 42003
        • Four Rivers Clincial Research
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Ochsner Clinic Foundation, Baton Rouge
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Biolab Research LLC
    • Michigan
      • Flint, Michigan, United States, 48504
        • Aa Mrc Llc
      • Flint, Michigan, United States, 48532
        • Elite Research Center LLC
      • Flint, Michigan, United States, 48532
        • Endocrine Consultants of Mid Michigan
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Seacost Kidney & Hypertension Specialists
    • New York
      • Albany, New York, United States, 12206
        • Albany Medical College, Division of Community Endocinology
    • North Carolina
      • Asheboro, North Carolina, United States, 27203
        • Randolph Health Internal Medicine
      • Morehead City, North Carolina, United States, 28557
        • Carteret Medical Group
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington, LLC
      • Winston-Salem, North Carolina, United States, 27103
        • Brookview Hills Research Associates, LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73111
        • Synexus Clinical Research US, Inc. Centennial Health, PC
    • Pennsylvania
      • Lansdale, Pennsylvania, United States, 19446
        • Detweiler Family Medicine & Associates, PC
    • Tennessee
      • Chattanooga, Tennessee, United States, 37411
        • University Diabetes & Endocrine Consultants
      • Knoxville, Tennessee, United States, 37923
        • Knoxville Kidney Center, PLLC
    • Texas
      • Dallas, Texas, United States, 75243
        • Texas Health Physicians Group
      • Fort Worth, Texas, United States, 76116
        • The Medical Group Of Texas
      • Fort Worth, Texas, United States, 76164
        • Rockwood Medical Clinic
      • Houston, Texas, United States, 77040
        • Juno Research, LLC
      • Houston, Texas, United States, 77004
        • Endocrine Associates
      • Houston, Texas, United States, 77079
        • The Endocrine Center
      • Houston, Texas, United States, 77099
        • Pioneer Research Solutions Inc
      • Houston, Texas, United States, 77429
        • Houston Nephrology Research
      • San Antonio, Texas, United States, 78212
        • Clinical Advancement Center, PLLC
      • San Antonio, Texas, United States, 78249
        • BFHC Research
      • Sugar Land, Texas, United States, 77478
        • Carl R. Meisner Medical Clinic, PLLC
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah School of Medicine
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Manassas Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes treated with ≥1 glucose-lowering medication for at least 12 months
  • UACR 200 to 3000 mg/g
  • eGFR ≥30 ml/min/1.73m2
  • Treated with at least the minimal recommended dose of an angiotensin converting enzyme inhibitor (ACEI) or an angiotensin II receptor blocker (ARB), but not both

Exclusion Criteria:

  • History of Type 1 diabetes
  • Women who are breast feeding
  • Treatment with any uric acid-lowering therapy within previous 2 weeks
  • History of intolerance to any XO (xanthine oxidase) inhibitor
  • History of a gout flare requiring pharmacologic treatment
  • History or presence of tophaceous gout
  • History of immunosuppressant treatment for any known or suspected renal disorder
  • History of a non-diabetic form of renal disease
  • Glycosylated hemoglobin (HbA1c) >11%
  • sUA <4.0 mg/dL or >10.0 mg/dL
  • Positive urinary pregnancy test
  • Dialysis for acute renal failure within previous 6 months
  • Renal allograft in place or a scheduled kidney transplant within the next 22 weeks
  • Congenital or acquired solitary kidney

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TMX-049 40 mg QD (Once Daily)
TMX-049: 40 mg of TMX-049 to be taken orally, once daily
Drug: TMX-049
A certain dose of TMX-049 to be taken orally, once daily
Experimental: TMX-049 200 mg QD (Once Daily)
TMX-049: 200 mg of TMX-049 to be taken orally, once daily
Drug: TMX-049
A certain dose of TMX-049 to be taken orally, once daily
Placebo Comparator: TMX-049 Placebo
Drug: Placebo
Matching placebo to be taken orally, once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Log-transformed Urinary Albumin-to-creatinine Ratio (UACR) at Week 12
Time Frame: Baseline and Week 12
UACR from Baseline to Weeks 2, 6, 12, and 16(Follow-up) were measured. The change from baseline at Week 12 in log-transformed UACR was analyzed and reported as a primary outcome.
Baseline and Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Estimated Glomerular Filtration Rate (GFR)
Time Frame: Baseline and Week 2, 6, 12, 16 (Follow-up)
Estimated Glomerular Filtration Rate from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured. The eGFR (estimated glomerular filtration rate) was calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula based on the serum creatinine measurement.
Baseline and Week 2, 6, 12, 16 (Follow-up)
Changes in Serum Uric Acid (sUA)
Time Frame: Baseline and Week 2, 6, 12, 16 (Follow-up)
Serum Uric Acid from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured in order to explore the sUA (Serum Uric Acid) lowering effect in DKD (diabetic kidney disease) patients and the relationship between sUA and efficacy to DKD.
Baseline and Week 2, 6, 12, 16 (Follow-up)
Changes in Urinary Albumin-to-Creatinine Ratio (UACR)
Time Frame: Baseline and Week 2, 6, 12, 16 (Follow-up)
Urinary Albumin-to-Creatinine Ratio from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.
Baseline and Week 2, 6, 12, 16 (Follow-up)
Proportion of Subjects With a Greater Than 30% Reduction From Baseline to Week 12 in Urinary Albumin-to-Creatinine Ratio
Time Frame: 16 Weeks
Changes in Proportion of Subjects With a Greater Than 30% Reduction From Baseline to Week 12 in Urinary Albumin-to-Creatinine Ratio were measured. Subject with greater than 30% reduction is estimated as responder, less than or equal to 30% reduction is estimated as non-responder.
16 Weeks
Changes in Exploratory Blood Biomarkers (C Reactive Protein)
Time Frame: 16 Weeks
Changes in Exploratory Blood Biomarkers for inflammation (C Reactive Protein) from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.
16 Weeks
Changes in Exploratory Blood Biomarkers (Soluble TNF Receptor Type I)
Time Frame: 16 Weeks
Changes in Exploratory Blood Biomarkers for inflammation (Soluble TNF [tumor necrosis factor] Receptor Type I) from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.
16 Weeks
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Fatty Acid Binding Protein 1)
Time Frame: 16 Weeks
Changes in Exploratory Renal Biomarkers for renal tubular diseases (Creatinine-Corrected Fatty Acid Binding Protein 1) from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.
16 Weeks
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Hydroxy Deoxyguanosine)
Time Frame: 16 Weeks
Changes in Exploratory Renal Biomarkers for renal tubular diseases (Creatinine-Corrected Hydroxy Deoxyguanosine) from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.
16 Weeks
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Kidney Injury Molecule-1)
Time Frame: 16 Weeks
Changes in Exploratory Renal Biomarkers for renal tubular diseases (Creatinine-Corrected Kidney Injury Molecule-1) from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.
16 Weeks
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected N-acetyl-beta-D-glucosaminidase)
Time Frame: 16 Weeks
Changes in Exploratory Renal Biomarkers for renal tubular diseases (Creatinine-Corrected N-acetyl-beta-D-glucosaminidase) from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.
16 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Teijin America, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Michael Cressman, D.O., Covance

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 7, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 4, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TMX-049DN-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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