search
Back to results

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

Primary Purpose

Diabetic Kidney Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TMX-049
Placebo
Sponsored by
Teijin America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Kidney Disease focused on measuring Diabetic Kidney Disease, XO inhibitor, UACR

Eligibility Criteria

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

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

Sites / Locations

  • AKDHC Medical Research Services, LLC
  • Aventiv Research Inc.
  • Comprehensive Research Institute
  • California Kidney Specialists
  • Torrance Clinical Research Institute, Inc.
  • Valley Clinical Trials, Inc.
  • Diabetes Associates Medical Group
  • Desert Oasis Healthcare Medical Group
  • California Kidney Specialists
  • North America Research Institute
  • San Marcus Research Clinic, Inc.
  • Leon Medical Research
  • Endocrine Associates of Florida, P.A.
  • Pines Care Research Center
  • Hanson Clinical Research Center
  • Nephrology Associates, PC
  • Southeastern Clinical Research Institute
  • East-West Medical Research Institute
  • Solaris Clinical Research, Llc
  • Associate in Endocrinology
  • Community Clinical Research Center
  • Community Hospital of Anderson and Madison County, Inc.
  • Iowa Kidney Physicians
  • Iowa Diabetes and Endocrinology Research Center
  • My Kidney Center, LLC.
  • Cotton O'Neil Clinical Research Center
  • Four Rivers Clincial Research
  • Ochsner Clinic Foundation, Baton Rouge
  • Biolab Research LLC
  • Aa Mrc Llc
  • Elite Research Center LLC
  • Endocrine Consultants of Mid Michigan
  • Seacost Kidney & Hypertension Specialists
  • Albany Medical College, Division of Community Endocinology
  • Randolph Health Internal Medicine
  • Carteret Medical Group
  • PMG Research of Wilmington, LLC
  • Brookview Hills Research Associates, LLC
  • Synexus Clinical Research US, Inc. Centennial Health, PC
  • Detweiler Family Medicine & Associates, PC
  • University Diabetes & Endocrine Consultants
  • Knoxville Kidney Center, PLLC
  • Texas Health Physicians Group
  • The Medical Group of Texas
  • Rockwood Medical Clinic
  • Endocrine Associates
  • Juno Research, LLC
  • The Endocrine Center
  • Pioneer Research Solutions INC
  • Houston Nephrology Research
  • Clinical Advancement Center, PLLC
  • BFHC Research
  • Carl R. Meisner Medical Clinic, PLLC
  • University of Utah School of Medicine
  • Manassas Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

TMX-049 40 mg QD (Once Daily)

TMX-049 200 mg QD (Once Daily)

TMX-049 Placebo

Arm Description

TMX-049: 40 mg of TMX-049 to be taken orally, once daily

TMX-049: 200 mg of TMX-049 to be taken orally, once daily

Outcomes

Primary Outcome Measures

Changes in Log-transformed Urinary Albumin-to-creatinine Ratio (UACR) at 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.

Secondary Outcome Measures

Changes in Estimated Glomerular Filtration Rate (GFR)
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.
Changes in Serum Uric Acid (sUA)
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.
Changes in Urinary Albumin-to-Creatinine Ratio (UACR)
Urinary Albumin-to-Creatinine Ratio from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.
Proportion of Subjects With a Greater Than 30% Reduction From Baseline to Week 12 in Urinary Albumin-to-Creatinine Ratio
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.
Changes in Exploratory Blood Biomarkers (C Reactive Protein)
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.
Changes in Exploratory Blood Biomarkers (Soluble TNF Receptor Type I)
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.
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Fatty Acid Binding Protein 1)
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.
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Hydroxy Deoxyguanosine)
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.
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Kidney Injury Molecule-1)
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.
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected N-acetyl-beta-D-glucosaminidase)
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.

Full Information

First Posted
February 9, 2018
Last Updated
August 1, 2022
Sponsor
Teijin America, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03449199
Brief Title
Phase 2 Study of TMX-049 in Subjects With Type 2 Diabetes and Albuminuria
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 10, 2018 (Actual)
Primary Completion Date
May 7, 2019 (Actual)
Study Completion Date
June 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teijin America, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Kidney Disease
Keywords
Diabetic Kidney Disease, XO inhibitor, UACR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TMX-049 40 mg QD (Once Daily)
Arm Type
Experimental
Arm Description
TMX-049: 40 mg of TMX-049 to be taken orally, once daily
Arm Title
TMX-049 200 mg QD (Once Daily)
Arm Type
Experimental
Arm Description
TMX-049: 200 mg of TMX-049 to be taken orally, once daily
Arm Title
TMX-049 Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TMX-049
Intervention Description
A certain dose of TMX-049 to be taken orally, once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo to be taken orally, once daily
Primary Outcome Measure Information:
Title
Changes in Log-transformed Urinary Albumin-to-creatinine Ratio (UACR) at Week 12
Description
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.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Changes in Estimated Glomerular Filtration Rate (GFR)
Description
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.
Time Frame
Baseline and Week 2, 6, 12, 16 (Follow-up)
Title
Changes in Serum Uric Acid (sUA)
Description
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.
Time Frame
Baseline and Week 2, 6, 12, 16 (Follow-up)
Title
Changes in Urinary Albumin-to-Creatinine Ratio (UACR)
Description
Urinary Albumin-to-Creatinine Ratio from Baseline to Weeks 2, 6, 12/early termination, and 16 (Follow-up) were measured.
Time Frame
Baseline and Week 2, 6, 12, 16 (Follow-up)
Title
Proportion of Subjects With a Greater Than 30% Reduction From Baseline to Week 12 in Urinary Albumin-to-Creatinine Ratio
Description
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.
Time Frame
16 Weeks
Title
Changes in Exploratory Blood Biomarkers (C Reactive Protein)
Description
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.
Time Frame
16 Weeks
Title
Changes in Exploratory Blood Biomarkers (Soluble TNF Receptor Type I)
Description
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.
Time Frame
16 Weeks
Title
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Fatty Acid Binding Protein 1)
Description
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.
Time Frame
16 Weeks
Title
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Hydroxy Deoxyguanosine)
Description
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.
Time Frame
16 Weeks
Title
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Kidney Injury Molecule-1)
Description
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.
Time Frame
16 Weeks
Title
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected N-acetyl-beta-D-glucosaminidase)
Description
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.
Time Frame
16 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Cressman, D.O.
Organizational Affiliation
Covance
Official's Role
Study Director
Facility Information:
Facility Name
AKDHC Medical Research Services, LLC
City
Flagstaff
State/Province
Arizona
ZIP/Postal Code
86001
Country
United States
Facility Name
Aventiv Research Inc.
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
Comprehensive Research Institute
City
Alhambra
State/Province
California
ZIP/Postal Code
91801
Country
United States
Facility Name
California Kidney Specialists
City
Covina
State/Province
California
ZIP/Postal Code
91723
Country
United States
Facility Name
Torrance Clinical Research Institute, Inc.
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Valley Clinical Trials, Inc.
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Diabetes Associates Medical Group
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Desert Oasis Healthcare Medical Group
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
California Kidney Specialists
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
Facility Name
North America Research Institute
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
Facility Name
San Marcus Research Clinic, Inc.
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Leon Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Endocrine Associates of Florida, P.A.
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Pines Care Research Center
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
Hanson Clinical Research Center
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Nephrology Associates, PC
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Southeastern Clinical Research Institute
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
East-West Medical Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Solaris Clinical Research, Llc
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Facility Name
Associate in Endocrinology
City
Elgin
State/Province
Illinois
ZIP/Postal Code
60124
Country
United States
Facility Name
Community Clinical Research Center
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46011
Country
United States
Facility Name
Community Hospital of Anderson and Madison County, Inc.
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46011
Country
United States
Facility Name
Iowa Kidney Physicians
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Iowa Diabetes and Endocrinology Research Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
My Kidney Center, LLC.
City
Manhattan
State/Province
Kansas
ZIP/Postal Code
66502
Country
United States
Facility Name
Cotton O'Neil Clinical Research Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Four Rivers Clincial Research
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Ochsner Clinic Foundation, Baton Rouge
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Biolab Research LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Aa Mrc Llc
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
Elite Research Center LLC
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Endocrine Consultants of Mid Michigan
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Seacost Kidney & Hypertension Specialists
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Albany Medical College, Division of Community Endocinology
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Randolph Health Internal Medicine
City
Asheboro
State/Province
North Carolina
ZIP/Postal Code
27203
Country
United States
Facility Name
Carteret Medical Group
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
PMG Research of Wilmington, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Brookview Hills Research Associates, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Synexus Clinical Research US, Inc. Centennial Health, PC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73111
Country
United States
Facility Name
Detweiler Family Medicine & Associates, PC
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
Country
United States
Facility Name
University Diabetes & Endocrine Consultants
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37411
Country
United States
Facility Name
Knoxville Kidney Center, PLLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
Facility Name
Texas Health Physicians Group
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
The Medical Group of Texas
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76116
Country
United States
Facility Name
Rockwood Medical Clinic
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76164
Country
United States
Facility Name
Endocrine Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Juno Research, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77040
Country
United States
Facility Name
The Endocrine Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Pioneer Research Solutions INC
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Houston Nephrology Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77429
Country
United States
Facility Name
Clinical Advancement Center, PLLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
BFHC Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Carl R. Meisner Medical Clinic, PLLC
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
University of Utah School of Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Manassas Clinical Research Center
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35369650
Citation
Bakris GL, Mikami H, Hirata M, Nakajima A, Cressman MD. A Non-purine Xanthine Oxidoreductase Inhibitor Reduces Albuminuria in Patients with DKD: A Randomized Controlled Trial. Kidney360. 2021 Jun 30;2(8):1240-1250. doi: 10.34067/KID.0001672021. eCollection 2021 Aug 26.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs