SER150 vs Placebo in Diabetic Kidney Disease

• Status: Recruiting
• Trial end date: 2023-04-15
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Serodus ASA

Criteria

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) ≤ 8%

• 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 > 8%

• eGFRcrea ≥75 mL/minute/1.73 m^2 and ≤ 25 mL/minute/1.73 m^2

• Pregnant or lactating women