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CompletedNCT03449199Updated Aug 30, 2022Results posted

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

A Phase 2 interventional study of TMX-049 and Placebo in Diabetic Kidney Disease, sponsored by Teijin America, Inc.. Completed at 55 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-30.

Sponsored by Teijin America, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetic Kidney Disease

Keywords

  • Diabetic Kidney Disease
  • XO inhibitor
  • UACR
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
130 participants (actual)

Study arms

  • Experimental
    TMX-049 40 mg QD (Once Daily)

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

    Drug: TMX-049

  • Experimental
    TMX-049 200 mg QD (Once Daily)

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

    Drug: TMX-049

  • Placebo comparator
    TMX-049 Placebo

    Drug: Placebo

Interventions

  • DrugTMX-049

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

  • DrugPlacebo

    Matching placebo to be taken orally, once daily

05

What researchers measure

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.

    Time frame: Baseline and Week 12

Secondary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

    Time frame: 16 Weeks

  5. 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.

    Time frame: 16 Weeks

  6. 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.

    Time frame: 16 Weeks

  7. 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.

    Time frame: 16 Weeks

  8. 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.

    Time frame: 16 Weeks

  9. 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.

    Time frame: 16 Weeks

  10. 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.

    Time frame: 16 Weeks

06

Results

Posted Aug 1, 2022

Participant flow

Participant flow — Overall Study
MilestoneTMX-049 PlaceboTMX-049 40mg QDTMX-049 200mg QD
Started424444
Completed414342
Not completed112
Withdrew: Lost to follow-up110
Withdrew: Protocol deviation001
Withdrew: Withdrawal by subject001

Outcome measures

PrimaryChanges 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.

Time frame:
Baseline and Week 12
Reported as:
Least squares mean · Log(mg/g)
Changes in Log-transformed Urinary Albumin-to-creatinine Ratio (UACR) at Week 12
Log(mg/g)TMX-049 PlaceboTMX-049 40 mg QDTMX-049 200 mg QD
Changes in Log-transformed Urinary Albumin-to-creatinine Ratio (UACR) at Week 12-0.10 ± 0.153-0.15 ± 0.151-0.53 ± 0.150
Statistical analysis
  • TMX-049 Placebo vs TMX-049 40 mg QD · ANCOVA · p = 0.7953 · Ls mean difference: -0.05 · 95% CI -0.44 to 0.34
  • TMX-049 Placebo vs TMX-049 200 mg QD · ANCOVA · p = 0.0311 · Ls mean difference: -0.43 · 95% CI -0.82 to -0.04
SecondaryChanges 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.

Time frame:
Baseline and Week 2, 6, 12, 16 (Follow-up)
Reported as:
Least squares mean · ml/min/1.73 m^2
Changes in Estimated Glomerular Filtration Rate (GFR)
ml/min/1.73 m^2TMX-049 PlaceboTMX-049 40 mg QDTMX-049 200 mg QD
Visit 4 (Week 2)-0.02 ± 1.5910.98 ± 1.6010.18 ± 1.561
Visit 5 (Week 6)-1.41 ± 1.757-1.06 ± 1.7320.00 ± 1.724
Visit 6/ET (Week 12)-2.34 ± 1.585-0.62 ± 1.5631.09 ± 1.556
Visit 7/Follow up (Week 16)-2.39 ± 1.7261.57 ± 1.7020.99 ± 1.695
Statistical analysis
  • TMX-049 Placebo vs TMX-049 40 mg QD · ANCOVA · p = 0.4055 · Ls mean difference: 1.71 · 95% CI -2.35 to 5.78
  • TMX-049 Placebo vs TMX-049 200 mg QD · ANCOVA · p = 0.0960 · Ls mean difference: 3.42 · 95% CI -0.62 to 7.46
SecondaryChanges 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.

Time frame:
Baseline and Week 2, 6, 12, 16 (Follow-up)
Reported as:
Least squares mean · mg/dL
Changes in Serum Uric Acid (sUA)
mg/dLTMX-049 PlaceboTMX-049 40 mg QDTMX-049 200 mg QD
Visit 4 (Week 2)-0.03 ± 0.238-2.57 ± 0.240-3.54 ± 0.234
Visit 5 (Week 6)-0.22 ± 0.256-2.54 ± 0.252-3.34 ± 0.251
Visit 6/ET (Week 12)-0.07 ± 0.269-2.51 ± 0.266-3.30 ± 0.265
Visit 7/Follow up (Week 16)0.21 ± 0.190-0.13 ± 0.188-0.33 ± 0.187
Statistical analysis
  • TMX-049 Placebo vs TMX-049 40 mg QD · ANCOVA · p = <0.0001 · Ls mean difference: -2.43 · 95% CI -3.13 to -1.74
  • TMX-049 Placebo vs TMX-049 200 mg QD · ANCOVA · p = <0.0001 · Ls mean difference: -3.23 · 95% CI -3.91 to -2.54
SecondaryChanges 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.

Time frame:
Baseline and Week 2, 6, 12, 16 (Follow-up)
Reported as:
Least squares mean · mg/g
Changes in Urinary Albumin-to-Creatinine Ratio (UACR)
mg/gTMX-049 PlaceboTMX-049 40 mg QDTMX-049 200 mg QD
Visit 4 (Week 2)25.44 ± 69.16653.88 ± 68.229-86.20 ± 67.932
Visit 5 (Week 6)-81.90 ± 68.156-30.37 ± 67.233-86.12 ± 66.940
Visit 6/ET (Week 12)61.92 ± 92.291-40.10 ± 91.041-135.57 ± 90.645
Visit 7/ Follow up (Week 16)72.07 ± 90.04558.31 ± 88.825-8.27 ± 88.439
Statistical analysis
  • TMX-049 Placebo vs TMX-049 40 mg QD · ANCOVA · p = 0.3955 · Ls mean difference: -102.02 · 95% CI -338.81 to 134.78
  • TMX-049 Placebo vs TMX-049 200 mg QD · ANCOVA · p = 0.0991 · Ls mean difference: -197.49 · 95% CI -432.73 to 37.75
SecondaryProportion 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.

Time frame:
16 Weeks
Reported as:
Count of participants · Participants
Proportion of Subjects With a Greater Than 30% Reduction From Baseline to Week 12 in Urinary Albumin-to-Creatinine Ratio
ParticipantsTMX-049 PlaceboTMX-049 40 mg QDTMX-049 200 mg QD
Responder101419
Non-responder322925
Statistical analysis
  • TMX-049 Placebo · Regression, Logistic · p = 0.2791 · Odds ratio (or): 1.72Missing observations at Study Week 12 are imputed as nonresponse.
  • TMX-049 Placebo vs TMX-049 200 mg QD · Regression, Logistic · p = 0.0507 · Odds ratio (or): 2.57
SecondaryChanges 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.

Time frame:
16 Weeks
Reported as:
Mean · mg/dL
Changes in Exploratory Blood Biomarkers (C Reactive Protein)
mg/dLTMX-049 PlaceboTMX-049 40 mg QDTMX-049 200 mg QD
Visit 4 (Week 2)0.046 ± 0.51680.014 ± 0.53840.087 ± 0.6194
Visit 5 (Week 6)-0.011 ± 0.64430.003 ± 0.3688-0.084 ± 0.4303
Visit 6/ET (Week 12)0.000 ± 0.7527-0.144 ± 0.36910.000 ± 0.5176
Visit 7/ Follow up (Week 16)0.012 ± 0.6507-0.084 ± 0.3606-0.046 ± 0.3917
SecondaryChanges 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.

Time frame:
16 Weeks
Reported as:
Mean · ng/L
Changes in Exploratory Blood Biomarkers (Soluble TNF Receptor Type I)
ng/Lfor 12 weeksTMX-049 PlaceboTMX-049 40 mg QDTMX-049 200 mg QD
Visit 4 (Week 2)-13.7 ± 367.11-92.3 ± 298.8338.7 ± 360.03
Visit 5 (Week 6)-77.1 ± 295.5047.6 ± 485.9260.7 ± 397.76
Visit 6 (Week 12)16.5 ± 371.8810.8 ± 455.1143.8 ± 265.35
Visit 7/Follow up (Week 16)-25.8 ± 366.94-36.3 ± 308.7913.8 ± 320.22
SecondaryChanges 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.

Time frame:
16 Weeks
Reported as:
Mean · ug/L/mg/dL
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Fatty Acid Binding Protein 1)
ug/L/mg/dLTMX-049 PlaceboTMX-049 40 mg QDTMX-049 200 mg QD
Visit 4 (Week 2)0.03 ± 0.1610.01 ± 0.214-0.04 ± 0.201
Visit 5 (Week 6)-0.04 ± 0.3090.04 ± 0.258-0.04 ± 0.201
Visit 6 (Week 12)-0.01 ± 0.317-0.01 ± 0.136-0.01 ± 0.218
Visit 7/Follow up (Week 16)0.02 ± 0.3210.04 ± 0.2890.00 ± 0.188
SecondaryChanges 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.

Time frame:
16 Weeks
Reported as:
Mean · nmol/L/mg/dL
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Hydroxy Deoxyguanosine)
nmol/L/mg/dLTMX-049 PlaceboTMX-049 40 mg QDTMX-049 200 mg QD
Visit 4 (Week 2)1.47 ± 4.2664.70 ± 4.1236.08 ± 5.809
Visit 5 (Week 6)1.72 ± 5.1793.22 ± 5.3214.88 ± 5.930
Visit 6 (Week 12)-1.86 ± 5.3723.75 ± 6.1576.87 ± 10.476
Visit 7/ Follow up (Week 16)1.20 ± 5.480-0.07 ± 5.647-3.14 ± 5.211
SecondaryChanges 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.

Time frame:
16 Weeks
Reported as:
Mean · ug/L/mg/dL
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected Kidney Injury Molecule-1)
ug/L/mg/dLTMX-049 PlaceboTMX-049 40 mg QDTMX-049 200 mg QD
Visit 4 (Week 2)0.00 ± 0.0100.00 ± 0.0160.00 ± 0.007
Visit 5 (Week 6)0.00 ± 0.0100.00 ± 0.0150.00 ± 0.006
Visit 6 (Week 12)0.00 ± 0.0190.00 ± 0.0150.00 ± 0.008
Visit 7/Follow up (Week 16)0.00 ± 0.0090.00 ± 0.00140.00 ± 0.009
SecondaryChanges 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.

Time frame:
16 Weeks
Reported as:
Mean · U/L/mg/dL
Changes in Exploratory Renal Biomarkers (Creatinine-Corrected N-acetyl-beta-D-glucosaminidase)
U/L/mg/dLTMX-049 PlaceboTMX-049 40 mg QDTMX-049 200 mg QD
Visit 4 (Week 2)-0.01 ± 0.1290.03 ± 0.136-0.01 ± 0.152
Visit 5 (Week 6)0.02 ± 0.1540.02 ± 0.121-0.02 ± 0.147
Visit 6 (Week 12)0.00 ± 0.1230.02 ± 0.143-0.02 ± 0.108
Visit 7/Follow up (Week 16)0.01 ± 0.0890.02 ± 0.116-0.01 ± 0.132

Adverse events

Collected over Adverse event (AE) reporting began from the time of informed consent and ends at the Follow-up Visit (Visit 7), up to 16 weeks. For subjects without the Follow-up Visit, the reporting ends 28 days after the last dose of the Investigational Medicinal Product, up to 12 weeks.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TMX-049 Placebo0/42 (0%)4/42 (9.5%)18/42 (42.9%)
TMX-049 40 mg QD0/44 (0%)4/44 (9.1%)19/44 (43.2%)
TMX-049: 200 mg0/44 (0%)2/44 (4.5%)17/44 (38.6%)
Most frequent serious events
Showing 10 of 13
Most frequent serious events
EventTMX-049 PlaceboTMX-049 40 mg QDTMX-049: 200 mg
Cardiac failure chronicCardiac disorders1/420/440/44
Cholecystitis infectiveInfections and infestations1/420/440/44
PneumoniaInfections and infestations1/420/440/44
Lumbar radiculopathyNervous system disorders1/420/440/44
Acute kidney injuryRenal and urinary disorders1/421/440/44
AsthmaRespiratory, thoracic and mediastinal disorders1/420/440/44
Respiratory failureRespiratory, thoracic and mediastinal disorders1/420/440/44
Pancreatitis acuteGastrointestinal disorders0/421/440/44
SepsisInfections and infestations0/421/440/44
HypoglycaemiaMetabolism and nutrition disorders0/421/440/44
Most frequent other events
Showing 10 of 99
Most frequent other events
EventTMX-049 PlaceboTMX-049 40 mg QDTMX-049: 200 mg
NasopharyngitisInfections and infestations3/420/441/44
Urinary tract infectionInfections and infestations3/421/441/44
DiarrhoeaGastrointestinal disorders2/420/443/44
NauseaGastrointestinal disorders0/423/443/44
Oedema peripheralGeneral disorders1/423/440/44
HeadacheNervous system disorders2/420/441/44
HypothyroidismEndocrine disorders0/422/440/44
OedemaGeneral disorders1/422/440/44
InfluenzaInfections and infestations0/422/440/44
Upper respiratory tract infectionInfections and infestations0/422/440/44

Baseline characteristics

Age, Continuous
Age, Continuous(years)TMX-049 PlaceboTMX-049 40 mg QDTMX-049 200 mg QDTotal
Mean65 ± 10.366 ± 10.768 ± 1066 ± 10.3
Sex: Female, Male
Sex: Female, Male(Participants)TMX-049 PlaceboTMX-049 40 mg QDTMX-049 200 mg QDTotal
Female18171853
Male24262676
Race (NIH/OMB)
Race (NIH/OMB)(Participants)TMX-049 PlaceboTMX-049 40 mg QDTMX-049 200 mg QDTotal
American Indian or Alaska Native0101
Asian4217
Native Hawaiian or Other Pacific Islander0000
Black or African American52815
White323835105
More than one race1001
Unknown or Not Reported0000
Weight
Weight(kg)TMX-049 PlaceboTMX-049 40 mg QDTMX-049 200 mg QDTotal
Mean90.1 ± 19.8195.9 ± 20.5898.8 ± 23.6395.0 ± 21.57
BMI
BMI(kg/m^2)TMX-049 PlaceboTMX-049 40 mg QDTMX-049 200 mg QDTotal
Mean31.6 ± 6.0033.6 ± 6.5734.3 ± 7.2632.2 ± 6.69
07

Study locations

55 sites
  • AKDHC Medical Research Services, LLC
    Flagstaff, Arizona 86001, United States
  • Aventiv Research Inc.
    Mesa, Arizona 85210, United States
  • Comprehensive Research Institute
    Alhambra, California 91801, United States
  • California Kidney Specialists
    Covina, California 91723, United States
  • Torrance Clinical Research Institute, Inc.
    Lomita, California 90717, United States
  • Valley Clinical Trials, Inc.
    Northridge, California 91325, United States
  • Diabetes Associates Medical Group
    Orange, California 92868, United States
  • Desert Oasis Healthcare Medical Group
    Palm Springs, California 92262, United States
  • California Kidney Specialists
    San Dimas, California 91773, United States
  • North America Research Institute
    San Dimas, California 91773, United States
  • San Marcus Research Clinic, Inc.
    Miami Lakes, Florida 33014, United States
  • Leon Medical Research
    Miami, Florida 33015, United States
  • Endocrine Associates of Florida, P.A.
    Ocoee, Florida 34761, United States
  • Pines Care Research Center
    Pembroke Pines, Florida 33026, United States
  • Hanson Clinical Research Center
    Port Charlotte, Florida 33952, United States
  • Nephrology Associates, PC
    Augusta, Georgia 30901, United States
  • Southeastern Clinical Research Institute
    Augusta, Georgia 30909, United States
  • East-West Medical Research Institute
    Honolulu, Hawaii 96814, United States
  • Solaris Clinical Research, Llc
    Meridian, Idaho 83646, United States
  • Associate in Endocrinology
    Elgin, Illinois 60124, United States
  • Community Clinical Research Center
    Anderson, Indiana 46011, United States
  • Community Hospital of Anderson and Madison County, Inc.
    Anderson, Indiana 46011, United States
  • Iowa Kidney Physicians
    Des Moines, Iowa 50265, United States
  • Iowa Diabetes and Endocrinology Research Center
    West Des Moines, Iowa 50265, United States
  • My Kidney Center, LLC.
    Manhattan, Kansas 66502, United States
  • Cotton O'Neil Clinical Research Center
    Topeka, Kansas 66606, United States
  • Four Rivers Clincial Research
    Paducah, Kentucky 42003, United States
  • Ochsner Clinic Foundation, Baton Rouge
    Baton Rouge, Louisiana 70809, United States
  • Biolab Research LLC
    Rockville, Maryland 20852, United States
  • Aa Mrc Llc
    Flint, Michigan 48504, United States
  • Elite Research Center LLC
    Flint, Michigan 48532, United States
  • Endocrine Consultants of Mid Michigan
    Flint, Michigan 48532, United States
  • Seacost Kidney & Hypertension Specialists
    Portsmouth, New Hampshire 03801, United States
  • Albany Medical College, Division of Community Endocinology
    Albany, New York 12206, United States
  • Randolph Health Internal Medicine
    Asheboro, North Carolina 27203, United States
  • Carteret Medical Group
    Morehead City, North Carolina 28557, United States
  • PMG Research of Wilmington, LLC
    Wilmington, North Carolina 28401, United States
  • Brookview Hills Research Associates, LLC
    Winston-Salem, North Carolina 27103, United States
  • Synexus Clinical Research US, Inc. Centennial Health, PC
    Oklahoma City, Oklahoma 73111, United States
  • Detweiler Family Medicine & Associates, PC
    Lansdale, Pennsylvania 19446, United States
  • University Diabetes & Endocrine Consultants
    Chattanooga, Tennessee 37411, United States
  • Knoxville Kidney Center, PLLC
    Knoxville, Tennessee 37923, United States
  • Texas Health Physicians Group
    Dallas, Texas 75243, United States
  • The Medical Group of Texas
    Fort Worth, Texas 76116, United States
  • Rockwood Medical Clinic
    Fort Worth, Texas 76164, United States
  • Endocrine Associates
    Houston, Texas 77004, United States
  • Juno Research, LLC
    Houston, Texas 77040, United States
  • The Endocrine Center
    Houston, Texas 77079, United States
  • Pioneer Research Solutions INC
    Houston, Texas 77099, United States
  • Houston Nephrology Research
    Houston, Texas 77429, United States
  • Clinical Advancement Center, PLLC
    San Antonio, Texas 78212, United States
  • BFHC Research
    San Antonio, Texas 78249, United States
  • Carl R. Meisner Medical Clinic, PLLC
    Sugar Land, Texas 77478, United States
  • University of Utah School of Medicine
    Salt Lake City, Utah 84108, United States
  • Manassas Clinical Research Center
    Manassas, Virginia 20110, United States
08

References and documents

Publications

  • 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. PubMed 35369650 ↗

Study documents

  • Study protocol · Feb 7, 2018
  • Statistical analysis plan · Apr 12, 2019

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03449199
Lead sponsor
Teijin America, Inc.
Responsible party
Sponsor
First posted
Feb 28, 2018
Start date
Apr 10, 2018
Primary completion
May 7, 2019
Completion
Jun 4, 2019
Results posted
Aug 1, 2022
Last update
Aug 30, 2022

Study contacts

Michael Cressman, D.O.
study director · Covance

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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Other studies from this sponsor

Teijin America, Inc.

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