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

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ClinicalTrials.gov Identifier: NCT03449199
Recruitment Status : Completed
First Posted : February 28, 2018
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Teijin America, Inc.

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.

Condition or disease Intervention/treatment Phase
Diabetic Kidney Disease Drug: TMX-049 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 10, 2018
Actual Primary Completion Date : May 7, 2019
Actual Study Completion Date : June 4, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TMX-049 dose 1 Drug: TMX-049
A certain dose of TMX-049 to be taken orally, once daily

Experimental: TMX-049 dose 2 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




Primary Outcome Measures :
  1. Change in log-transformed urinary albumin-to-creatinine ratio (UACR) [ Time Frame: 12 Weeks ]

Secondary Outcome Measures :
  1. Proportion of subjects with >30% reduction in UACR [ Time Frame: 12 Weeks ]
  2. Change in estimated glomerular filtration rate (eGFR) [ Time Frame: 12 Weeks ]
  3. Change in Kidney injury molecule 1 (KIM-1) [ Time Frame: 12 Weeks ]
  4. Change in Liver fatty acid binding protein (L-FABP) [ Time Frame: 12 Weeks ]
  5. Change in 8 hydroxy 2' deoxyguanosine (8-OHdG) [ Time Frame: 12 Weeks ]
  6. Change in N-acetyl-β-D-glucosaminidase (NAG) [ Time Frame: 12 Weeks ]
  7. Change in Soluble tumor necrosis factor receptor 1 (sTNFR1) [ Time Frame: 12 Weeks ]
  8. Change in high sensitivity C reactive protein; (hs-CRP) [ Time Frame: 12 Weeks ]
  9. Change in serum uric acid (sUA) [ Time Frame: 12 Weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

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): NCT03449199


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Sponsors and Collaborators
Teijin America, Inc.
Investigators
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Study Director: Michael Cressman, D.O. Covance

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Responsible Party: Teijin America, Inc.
ClinicalTrials.gov Identifier: NCT03449199     History of Changes
Other Study ID Numbers: TMX-049DN-201
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Albuminuria
Urologic Diseases
Proteinuria
Urination Disorders
Urological Manifestations
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases