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

NCT03449199 | Completed Phase 2 Results FDA Drug

• 1 other identifier: TMX-049DN-201
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 55

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.

Conditions

Diabetic Kidney Disease

Keywords

Diabetic Kidney Disease; XO inhibitor; UACR

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Week 12

Secondary Outcomes (10)

• Changes in Estimated Glomerular Filtration Rate (GFR)

  Baseline and Week 2, 6, 12, 16 (Follow-up)

• Changes in Serum Uric Acid (sUA)

  Baseline and Week 2, 6, 12, 16 (Follow-up)

• Changes in Urinary Albumin-to-Creatinine Ratio (UACR)

  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

  16 Weeks

• Changes in Exploratory Blood Biomarkers (C Reactive Protein)

  16 Weeks

Study Arms (3)

TMX-049 40 mg QD (Once Daily)

EXPERIMENTAL

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

Drug: TMX-049

TMX-049 200 mg QD (Once Daily)

EXPERIMENTAL

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

Drug: TMX-049

TMX-049 Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TMX-049 DRUG

A certain dose of TMX-049 to be taken orally, once daily

TMX-049 200 mg QD (Once Daily); TMX-049 40 mg QD (Once Daily)

Placebo DRUG

Matching placebo to be taken orally, once daily

TMX-049 Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teijin America, Inc.: lead

Study Sites (55)

AKDHC Medical Research Services, LLC

Flagstaff, Arizona, 86001, United States

Location

Aventiv Research Inc.

Mesa, Arizona, 85210, United States

Location

Comprehensive Research Institute

Alhambra, California, 91801, United States

Location

California Kidney Specialists

Covina, California, 91723, United States

Location

Torrance Clinical Research Institute, Inc.

Lomita, California, 90717, United States

Location

Valley Clinical Trials, Inc.

Northridge, California, 91325, United States

Location

Diabetes Associates Medical Group

Orange, California, 92868, United States

Location

Desert Oasis Healthcare Medical Group

Palm Springs, California, 92262, United States

Location

California Kidney Specialists

San Dimas, California, 91773, United States

Location

North America Research Institute

San Dimas, California, 91773, United States

Location

Leon Medical Research

Miami, Florida, 33015, United States

Location

San Marcus Research Clinic, Inc.

Miami Lakes, Florida, 33014, United States

Location

Endocrine Associates of Florida, P.A.

Ocoee, Florida, 34761, United States

Location

Pines Care Research Center

Pembroke Pines, Florida, 33026, United States

Location

Hanson Clinical Research Center

Port Charlotte, Florida, 33952, United States

Location

Nephrology Associates, PC

Augusta, Georgia, 30901, United States

Location

Southeastern Clinical Research Institute

Augusta, Georgia, 30909, United States

Location

East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

Solaris Clinical Research, Llc

Meridian, Idaho, 83646, United States

Location

Associate in Endocrinology

Elgin, Illinois, 60124, United States

Location

Community Clinical Research Center

Anderson, Indiana, 46011, United States

Location

Community Hospital of Anderson and Madison County, Inc.

Anderson, Indiana, 46011, United States

Location

Iowa Kidney Physicians

Des Moines, Iowa, 50265, United States

Location

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, 50265, United States

Location

My Kidney Center, LLC.

Manhattan, Kansas, 66502, United States

Location

Cotton O'Neil Clinical Research Center

Topeka, Kansas, 66606, United States

Location

Four Rivers Clincial Research

Paducah, Kentucky, 42003, United States

Location

Ochsner Clinic Foundation, Baton Rouge

Baton Rouge, Louisiana, 70809, United States

Location

Biolab Research LLC

Rockville, Maryland, 20852, United States

Location

Aa Mrc Llc

Flint, Michigan, 48504, United States

Location

Elite Research Center LLC

Flint, Michigan, 48532, United States

Location

Endocrine Consultants of Mid Michigan

Flint, Michigan, 48532, United States

Location

Seacost Kidney & Hypertension Specialists

Portsmouth, New Hampshire, 03801, United States

Location

Albany Medical College, Division of Community Endocinology

Albany, New York, 12206, United States

Location

Randolph Health Internal Medicine

Asheboro, North Carolina, 27203, United States

Location

Carteret Medical Group

Morehead City, North Carolina, 28557, United States

Location

PMG Research of Wilmington, LLC

Wilmington, North Carolina, 28401, United States

Location

Brookview Hills Research Associates, LLC

Winston-Salem, North Carolina, 27103, United States

Location

Synexus Clinical Research US, Inc. Centennial Health, PC

Oklahoma City, Oklahoma, 73111, United States

Location

Detweiler Family Medicine & Associates, PC

Lansdale, Pennsylvania, 19446, United States

Location

University Diabetes & Endocrine Consultants

Chattanooga, Tennessee, 37411, United States

Location

Knoxville Kidney Center, PLLC

Knoxville, Tennessee, 37923, United States

Location

Texas Health Physicians Group

Dallas, Texas, 75243, United States

Location

The Medical Group of Texas

Fort Worth, Texas, 76116, United States

Location

Rockwood Medical Clinic

Fort Worth, Texas, 76164, United States

Location

Endocrine Associates

Houston, Texas, 77004, United States

Location

Juno Research, LLC

Houston, Texas, 77040, United States

Location

The Endocrine Center

Houston, Texas, 77079, United States

Location

Pioneer Research Solutions INC

Houston, Texas, 77099, United States

Location

Houston Nephrology Research

Houston, Texas, 77429, United States

Location

Clinical Advancement Center, PLLC

San Antonio, Texas, 78212, United States

Location

BFHC Research

San Antonio, Texas, 78249, United States

Location

Carl R. Meisner Medical Clinic, PLLC

Sugar Land, Texas, 77478, United States

Location

University of Utah School of Medicine

Salt Lake City, Utah, 84108, United States

Location

Manassas Clinical Research Center

Manassas, Virginia, 20110, United States

Location

Related Publications (1)

• 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.

  PMID: 35369650 DERIVED

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Results Point of Contact

• Title: President
• Organization: Teijin America, Inc.

clinical-trials-contact@teijinpo.com

1-415-887-9742

Study Officials

• Michael Cressman, D.O.

  Covance

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: February 28, 2018
• Study Start: April 10, 2018
• Primary Completion: May 7, 2019
• Study Completion: June 4, 2019
• Last Updated: August 30, 2022
• Results First Posted: August 1, 2022

Record last verified: 2022-08

Locations

US (55)