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Diabetic Kidney DiseasePhase 2/3NCT04881123

SER150 vs Placebo in Diabetic Kidney Disease

A Phase 2/3 study testing SER150 in people with Diabetic Kidney Disease, run by Serodus AS at 12 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Diabetic Kidney Disease
What is being tested?
SER150
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
12 sitesin 2 countries
Study dates
18 Aug 2021to 6 Jun 2024
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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
  • Treatment with anticoagulant drugs
  • Participation in another clinical trial of an investigational small molecule, antibody (or medical advice) within 30 days (or 5 half-lives of the drug, whichever is longer [if known]) prior to the start of IP administration on Day 2 (or within 6 months prior to the start of IP administration on Day 1 if the investigational drug was a biologic).
  • Alanine aminotransferase or aspartate aminotransferase values exceeding 5 x 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 ≤ 15 mL/minute/1.73 m^2
  • Allergy to the active substance or any of the excipients of the drug product
  • Pregnant or lactating women

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

Australia8 sites

  • Southern Adelaide Diabetes and Endocrine Services

    Adelaide, South Australia, 5046

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102

  • St Vincent's Hospital

    Fitzroy, Victoria, 3065

  • SA Endocrine Research

    Keswick, South Australia, 5035

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • The AIM Centre (Hunter Diabetes Centre)

    Merewether, New South Wales

  • Sunshine Hospital

    Saint Albans, Victoria, 3021

  • Royal North Shore Hospital

    Saint Leonards, New South Wales, 2065

Other trials in Australia

New Zealand4 sites

  • New Zealand Clinical Research (NZCR)

    Christchurch, 8011

  • Lakeland Clinical Trials Waikato

    Hamilton, Waikato Region, 3200

  • Pacific Clinical Research Clinic Rotorua

    Rotorua, Bay of Plenty, 3010

  • PCRN Silverdale Medical Centre

    Silverdale, Hibiscus Coast, 0932

Other trials in New Zealand

About this study

Official title: Randomized, Double-blind, Placebo-controlled, Parallel Groups, Multicenter Pivotal Study Assessing the Efficacy and Safety of 15 mg Twice a Day (BID) of SER150 in Well-controlled Type 2 Diabetic Patients With Diabetic Kidney Disease and Albuminuria in Treatment With an Angiotensin Converting Enzyme Inhibitor or an Angiotensin Receptor Antagonist

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).

Read the detailed description

This is a randomized, double-blind, placebo-controlled, parallel groups, multicenter pivotal study assessing the efficacy and safety of 15 mg BID (except on Day 168 15 mg QD) of SER150 in well-controlled adult T2D participants with stable concomitant medications, diabetic kidney disease (DKD) and albuminuria in treatment with an ACEi or an ARB.

The randomized treatment period will be 24 weeks followed by a 4-weeks follow-up.

Being tested
SER150, Placebo
Keywords
SER150, Urine albumin-creatinine ratio, Pivotal study, Type 2 diabetes, Albuminuria
Medical subject headings
Diabetic Nephropathies, Diabetes Mellitus, Type 2, Albuminuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SER150Drug

    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)

  • PlaceboDrug

    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)

Study groups in NCT04881123
Study groupRoleWhat they receive
SER150ExperimentalRandomized 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)
Receives: Drug: SER150
PlaceboPlacebo comparatorRandomized 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)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to Day 168

Secondary outcomes (7)

  1. Change of UACR from Baseline to Day 168

    Efficacy of 15 mg BID of SER150 will be determined in well-controlled type 2 diabetic participants with DKD, and albuminuria in treatment with an ACEi or an ARB.

    Measured: Baseline to Day 168

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

    Efficacy of 15 mg BID of SER150 will be determined in well-controlled type 2 diabetic participants with DKD, and albuminuria in treatment with an ACEi or an ARB. eGFRcrea is defined as estimated glomerular filtration rate using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation and eGFRcys is defined as estimated glomerular filtration rate using the CKD-EPI cystatin C equation.

    Measured: Baseline to Day 168

  3. Number of participants with a change in eGFRcrea and eGFRcys

    Efficacy of 15 mg BID of SER150 will be determined in well-controlled type 2 diabetic participants with DKD, and albuminuria in treatment with an ACEi or an ARB.

    Measured: Baseline to Day 168

  4. Number of participants with a change in eGFRcr-cys

    Efficacy of 15 mg BID of SER150 will be determined in well-controlled type 2 diabetic participants with DKD, and albuminuria in treatment with an ACEi or an ARB. eGFRcr-cys is defined as estimated glomerular filtration rate using CKD-EPI creatinine-cystatin C equation.

    Measured: Baseline to Day 168

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

    Efficacy of 15 mg BID of SER150 will be determined in well-controlled type 2 diabetic participants with DKD, and albuminuria in treatment with an ACEi or an ARB.

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

  6. Number of participants with adverse events (AEs)

    Safety/tolerability of 15 mg BID of SER150 will be determined in well-controlled type 2 diabetic participants with DKD, and albuminuria in treatment with an ACEi or an ARB.

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

  7. PK trough SER150 concentrations (pre-dose)

    Efficacy, Safety/tolerability of 15 mg BID of SER150 will be determined in well-controlled type 2 diabetic participants with DKD, and albuminuria in treatment with an ACEi or an ARB.

    Measured: D7, D28, D56, D84, D112, D140 and D168

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2021
  2. Study start18 Aug 2021
  3. Primary completion6 Jun 2024
  4. Study completion6 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04881123
Sponsor's protocol ID
SER150 CL-009
Status last verified
Nov 2023
First submitted
6 May 2021
Last updated
21 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing SER150 in people with Diabetic Kidney Disease, run by Serodus AS at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A change of urine albumin-to-creatinine ratio (UACR) of > 30% from Baseline to Day 168 (time frame: Baseline to Day 168). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04881123.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.

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