SER150 vs Placebo in Diabetic Kidney Disease

NCT04881123 | Completed Phase 2

• 1 other identifier: SER150 CL-009
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 12

Brief 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).

Conditions

Diabetic Kidney Disease

Keywords

SER150; Urine albumin-creatinine ratio; Pivotal study; Type 2 diabetes; Albuminuria

Outcome Measures

Primary Outcomes (1)

• A change of urine albumin-to-creatinine ratio (UACR) of > 30% from Baseline to Day 168

  The efficacy of 15 mg BID of SER150 with placebo will be compared in well controlled type 2 diabetic participants with DKD, and albuminuria in treatment with an ACEi or an ARB.

  Baseline to Day 168

Secondary Outcomes (7)

• Change of UACR from Baseline to Day 168

  Baseline to Day 168

• Time to change of eGFRcrea and eGFRcys ≥ 0.50 mL/min/1.73 m^2

  Baseline to Day 168

• Number of participants with a change in eGFRcrea and eGFRcys

  Baseline to Day 168

• Number of participants with a change in eGFRcr-cys

  Baseline to Day 168

• Number of participants with end stage renal disease, any serious cardiovascular events (stroke-acute myocardial infarction-cardiovascular death) and all-cause mortality

  Screening (up to 21 days before Day 1). Day 1 and from Day 7 until the Follow-up (Day 196)

Study Arms (2)

SER150

EXPERIMENTAL

Randomized participants will receive SER150, 15 mg, orally, BID (except on Day 168 where participants will only receive a 15 mg single dose (QD) in the morning)

Drug: SER150

Placebo

PLACEBO COMPARATOR

Randomized participants will receive matching placebo, orally, BID (except on Day 168 where participants will only receive a 15 mg single dose (QD) in the morning)

Drug: Placebo

Interventions

SER150 DRUG

Dosage Level(s): 30 mg (1 capsule of 15 mg twice a day - morning and evening) (except on Day 168 where participants will only receive a single dose (QD) in the morning)

SER150

Placebo DRUG

Dosage Level(s): Matched placebo (1 capsule twice a day - morning and evening) (except on Day 168 where participants will only receive a single dose (QD) in the morning)

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 participating in clinical studies

You may not qualify if:

• Acute myocardial infarction within the last 3 months
• Stroke within the last 3 months
• Any major surgery in the last 3 months that in the opinion of the Investigator poses an increased bleeding risk.
• ACR ≤ 200 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 had a confirmed COVID-19 infection by appropriate laboratory test (PCR or Rapid Antigen 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

Sponsors & Collaborators

• Serodus AS: lead

Study Sites (12)

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

The AIM Centre (Hunter Diabetes Centre)

Merewether, New South Wales, Australia

Location

Royal North Shore Hospital

Saint Leonards, New South Wales, 2065, Australia

Location

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

Southern Adelaide Diabetes and Endocrine Services

Adelaide, South Australia, 5046, Australia

Location

SA Endocrine Research

Keswick, South Australia, 5035, Australia

Location

St Vincent's Hospital

Fitzroy, Victoria, 3065, Australia

Location

Sunshine Hospital

Saint Albans, Victoria, 3021, Australia

Location

Pacific Clinical Research Clinic Rotorua

Rotorua, Bay of Plenty, 3010, New Zealand

Location

PCRN Silverdale Medical Centre

Silverdale, Hibiscus Coast, 0932, New Zealand

Location

Lakeland Clinical Trials Waikato

Hamilton, Waikato Region, 3200, New Zealand

Location

New Zealand Clinical Research (NZCR)

Christchurch, 8011, New Zealand

Location

MeSH Terms

Conditions

Diabetic Nephropathies; Diabetes Mellitus, Type 2; Albuminuria

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Proteinuria; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 11, 2021
• Study Start: August 18, 2021
• Primary Completion: June 6, 2024
• Study Completion: June 6, 2024
• Last Updated: June 21, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (4); AU (8)