SER150 vs Placebo in Diabetic Kidney Disease

  • STATUS
    Recruiting
  • End date
    Jun 15, 2023
  • participants needed
    100
  • sponsor
    Serodus ASA
Updated on 29 May 2022
diabetes
glycated hemoglobin
angiotensin
hemoglobin a1c
glycosylated hemoglobin
antidiabetics
angiotensin converting enzyme

Summary

This study is to assess the efficacy, safety and pharmacokinetic (PK) of SER150 administered for 12 weeks as a 15 mg twice a day (BID) dose in participants with type 2 diabetes (T2D) and macroalbuminuria in treatment with either an angiotensin converting enzyme inhibitor (ACEI) or an angiotensin receptor antagonist (ARB).

Description

This is a randomized, double-blind, placebo-controlled, parallel groups, multicenter pivotal study assessing the efficacy and safety of 15 mg BID of SER150 in well-controlled adult T2D participants with stable concomitant medications, diabetic kidney disease (DKD) and macroalbuminuria in treatment with an ACEI or an ARB.

The randomized treatment period will be 12 weeks followed by a 4-weeks follow-up.

Details
Condition Diabetic Kidney Disease
Treatment Placebo, SER150
Clinical Study IdentifierNCT04881123
SponsorSerodus ASA
Last Modified on29 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant has had stable T2D for 3 months prior to screening
Participant has albuminuria defined by urine UACR ≥ 300 mg/g creatinine(macroalbuminuria) as a mean of three independent first morning spot urines
Participant is receiving stable antidiabetic treatment (no change over past 3 months). 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 25 mL/minute/1.73 m^2 (CKD-EPI formula)
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 participating in clinical studies

Exclusion Criteria

Acute myocardial infarction within the last 3 months
Stroke within the last 3 months
ACR < 300 mg/g creatinine
Urinary bladder infections within the last 3 months (all other urinary tract infections and vulvovaginitis are excluded)
Recent history (within the last 6 months) or ongoing liver disease, including viral infections
Participants with HIV
Participants with known specific renal diseases different from DKD
Any bleeding disorder or acute blood coagulation defect
A history of gastric ulcers or any other organic lesion susceptible to bleeding
Participant has clinical signs and symptoms consistent with coronavirus disease 2019 (COVID-19), e.g. fever, dry cough, dyspnea, sore throat, fatigue or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or on admission
Participant who had severe course of COVID-19
Any other condition or clinically relevant abnormal findings in physical examination, laboratory results or ECG during screening period that, in the opinion of the Investigator, may compromise the safety of the participant in the study, reduce the participant's ability to participate in the study, or interfere with evaluation of the study drug
Change in antidiabetic treatment during last 3 months
Chronic treatment with nonsteroidal anti-inflammatory drugs or other anti-inflammatory compounds during the last month
Treatment with anticoagulant drugs
Alanine aminotransferase or aspartate aminotransferase values exceeding 2.5x upper limit of normal (ULN)
Alkaline phosphatase and/or total bilirubin values exceeding 1.5 x ULN
HbA1c > 10%
eGFRcrea ≥75 mL/minute/1.73 m^2 and ≤ 25 mL/minute/1.73 m^2
Pregnant or lactating women
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