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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04881123




Registration number
NCT04881123
Ethics application status
Date submitted
6/05/2021
Date registered
11/05/2021

Titles & IDs
Public title
SER150 vs Placebo in Diabetic Kidney Disease
Scientific 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
Secondary ID [1] 0 0
SER150 CL-009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Kidney Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SER150
Treatment: Drugs - Placebo

Experimental: SER150 - 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)

Placebo comparator: Placebo - 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)


Treatment: Drugs: SER150
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)

Treatment: Drugs: Placebo
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)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
A change of urine albumin-to-creatinine ratio (UACR) of > 30% from Baseline to Day 168
Timepoint [1] 0 0
Baseline to Day 168
Secondary outcome [1] 0 0
Change of UACR from Baseline to Day 168
Timepoint [1] 0 0
Baseline to Day 168
Secondary outcome [2] 0 0
Time to change of eGFRcrea and eGFRcys = 0.50 mL/min/1.73 m^2
Timepoint [2] 0 0
Baseline to Day 168
Secondary outcome [3] 0 0
Number of participants with a change in eGFRcrea and eGFRcys
Timepoint [3] 0 0
Baseline to Day 168
Secondary outcome [4] 0 0
Number of participants with a change in eGFRcr-cys
Timepoint [4] 0 0
Baseline to Day 168
Secondary outcome [5] 0 0
Number of participants with end stage renal disease, any serious cardiovascular events (stroke-acute myocardial infarction-cardiovascular death) and all-cause mortality
Timepoint [5] 0 0
Screening (up to 21 days before Day 1). Day 1 and from Day 7 until the Follow-up (Day 196)
Secondary outcome [6] 0 0
Number of participants with adverse events (AEs)
Timepoint [6] 0 0
Screening (up to 21 days before Day 1). Day 1 and from Day 7 until the Follow-up (Day 196)
Secondary outcome [7] 0 0
PK trough SER150 concentrations (pre-dose)
Timepoint [7] 0 0
D7, D28, D56, D84, D112, D140 and D168

Eligibility
Key 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 participating in clinical studies
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/06/2024
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
The AIM Centre (Hunter Diabetes Centre) - Merewether
Recruitment hospital [3] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [5] 0 0
Southern Adelaide Diabetes and Endocrine Services - Adelaide
Recruitment hospital [6] 0 0
SA Endocrine Research - Keswick
Recruitment hospital [7] 0 0
St Vincent's Hospital - Fitzroy
Recruitment hospital [8] 0 0
Sunshine Hospital - Saint Albans
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
- Merewether
Recruitment postcode(s) [3] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [4] 0 0
4102 - Brisbane
Recruitment postcode(s) [5] 0 0
5046 - Adelaide
Recruitment postcode(s) [6] 0 0
5035 - Keswick
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy
Recruitment postcode(s) [8] 0 0
3021 - Saint Albans
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Bay Of Plenty
Country [2] 0 0
New Zealand
State/province [2] 0 0
Hibiscus Coast
Country [3] 0 0
New Zealand
State/province [3] 0 0
Waikato
Country [4] 0 0
New Zealand
State/province [4] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Serodus AS
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Eva Steiness
Address 0 0
Country 0 0
Phone 0 0
0045 22265687
Fax 0 0
Email 0 0
eva.steiness@serodus.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04881123