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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).
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.
Age
18 - 85 years
Sex
ALL
Healthy Volunteers
No
Liverpool Hospital
Liverpool, New South Wales, Australia
The AIM Centre (Hunter Diabetes Centre)
Merewether, New South Wales, Australia
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Southern Adelaide Diabetes and Endocrine Services
Adelaide, South Australia, Australia
SA Endocrine Research
Keswick, South Australia, Australia
St Vincent's Hospital
Fitzroy, Victoria, Australia
Sunshine Hospital
Saint Albans, Victoria, Australia
Pacific Clinical Research Clinic Rotorua
Rotorua, Bay of Plenty, New Zealand
PCRN Silverdale Medical Centre
Silverdale, Hibiscus Coast, New Zealand
Start Date
August 18, 2021
Primary Completion Date
June 6, 2024
Completion Date
June 6, 2024
Last Updated
June 21, 2024
20
ACTUAL participants
SER150
DRUG
Placebo
DRUG
Lead Sponsor
Serodus AS
NCT07271186
NCT06600412
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05822609