SER150 vs Placebo in Diabetic Kidney Disease (NCT04881123) | Clinical Trial Compass
CompletedPhase 2/3
SER150 vs Placebo in Diabetic Kidney Disease
Australia20 participantsStarted 2021-08-18
Plain-language summary
This study is to assess the efficacy and safety of SER150 administered for 24 weeks as a 15 mg twice a day BID dose (except on Day 168 15 mg QD) in participants with type 2 diabetes (T2D) and albuminuria in treatment with either an angiotensin converting enzyme inhibitor (ACEi) or an angiotensin receptor antagonist (ARB).
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion Criteria:
* Participant has had stable T2D for 3 months prior to screening
* Participant has albuminuria defined by urine UACR ≥ 200 mg/g creatinine as a mean of three independent samples of first urine void of the day
* Participant is receiving stable antidiabetic treatment. Antidiabetic treatment includes all drugs given for the treatment of T2D
* Participant is in treatment with ACEi or ARB, with eGFRcrea lower than 75 mL/minute /1.73 m\^2 and above 15 mL/minute/1.73 m\^2 (CKD-EPI formula) and will not, in the opinion of the investigator, become a candidate for renal dialysis whilst on the study
* Participant is determined to be overtly healthy as determined by Investigator review of their medical history, physical examination, laboratory tests, and cardiac monitoring. It is anticipated that, whilst some of the participant's results may be different to that of a completely healthy individual, the Investigator will review the participant's individual results to ensure they are as healthy as can be expected give the participant's current health status
* Participant has ASA physical status, health class 2, 3 or 4
* Participant has blood pressure ≤ 160 mmHg systolic, and ≤ 100 mmHg diastolic
* Participant has normal electrocardiogram
* Participant has glycosylated hemoglobin (HbA1c) ≤ 10%
* Participant has prothrombin within normal values
* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those …
What they're measuring
1
A change of urine albumin-to-creatinine ratio (UACR) of > 30% from Baseline to Day 168