Safety, Tolerability and Renal Effects of APX-115 in Subjects With Type 2 Diabetes and Nephropathy
NCT ID: NCT04534439
Last Updated: 2021-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
140 participants
INTERVENTIONAL
2020-08-24
2021-08-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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APX-115
Oral administration of APX-115 400mg, daily
APX-115
oral administration of APX-115 400mg capsule once daily for 12 weeks
Placebo
Oral administration of APX-115-matching placebo 400mg, daily
Placebo
oral administration of APX-115-matching placebo 400mg capsule once daily for 12 weeks
Interventions
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APX-115
oral administration of APX-115 400mg capsule once daily for 12 weeks
Placebo
oral administration of APX-115-matching placebo 400mg capsule once daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* First morning void (FMV) UACR between 200 and 3000 mg/g, inclusive
* 30 mL/min/1.73m2 ≤ eGFR ≤ 90 mL/min/1.73m2 using CKD-EPI formula at screening
* HbA1c ≤ 10% at screening visit
* Subject who has been taking unchanged dosage of ACE inhibitor or ARB medication for at least 3 months prior to screening and is not anticipated to change its dosage during the course of the study
* Willing to be under dietary management for diabetes
Exclusion Criteria
* Subject's renal impairment and/or albuminuria is considered to be of origin other than Diabetic Kidney Disease
* Subject with uncontrolled blood pressure
* Clinically significant abnormal laboratory findings
* History of any cardiovascular event within 6 months prior to screening or cardiovascular procedure planned during the clinical trial
* Diagnostic or interventional procedure requiring a contrast agent within 4 weeks before the screening visit or planned during the course of the study
* Clinically significant ECG abnormalities on a 12-lead ECG at the screening visit or before randomization
* Current or history of NYHA class IV heart failure
18 Years
80 Years
ALL
No
Sponsors
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Aptabio Therapeutics, Inc.
INDIV
Responsible Party
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Principal Investigators
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Istavan Wittmann, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pecs
Locations
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Pleven
Pleven, , Bulgaria
Sveta Karidad
Plovdiv, , Bulgaria
Diagnostic-consultative centre I
Sliven, , Bulgaria
Hadzhi Dimitar
Sofia, , Bulgaria
HERA
Sofia, , Bulgaria
Medical center - Sveti Dimitar
Sofia, , Bulgaria
Sirtuin
Sofia, , Bulgaria
Sveta
Sofia, , Bulgaria
Hristo Botev
Vratsa, , Bulgaria
Sveti Panteleymon Yambol
Yambol, , Bulgaria
Nefromed s.r.o
Prague, , Czechia
Drug Research Center
Balatonfüred, , Hungary
UNO MEDICAL Trials Kft.
Budapest, , Hungary
Mint House Private Medical Center
Székesfehérvár, , Hungary
Bezanijska Kosa
Belgrade, , Serbia
Clinical Centre of Serbia, clinic for endocrinology, diabetes and metabolism diseases, department for obesity, metabolic and reproductive disorders
Belgrade, , Serbia
Countries
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Other Identifiers
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2019-004155-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A01-115-02-EU
Identifier Type: -
Identifier Source: org_study_id
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