Status:
NOT_YET_RECRUITING
Prevention of Chronic Kidney Disease(CDK) Progression in Type 1 Diabetes With Long Term Use of Sodium-Glucose-coTransporter Inhibitors Avoiding Kidney hypOxia
Lead Sponsor:
Steno Diabetes Center Copenhagen
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
King's College London
Conditions:
Nephropathy
Diabetic Nephropathies
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Background: Sodium-glucose-cotransporter (SGLT) inhibition has been observed to reduce risk of cardiovascular events and kidney failure in persons with type 2 diabetes. People with type 1 diabetes als...
Eligibility Criteria
Inclusion
- Persons ≥ 18 years of age with a diagnosis of type 1 diabetes (age at onset \<40 years; permanent insulin treatment initiated within 1 year of diagnosis)
- Albuminuria: UACR \> 100 mg/g (in ≥2 out 3 morning spot urine collections prior to randomization)
- estimated Glomerular Filtration Rate(eGFR) ≥25 and \< 75 ml/min/1.73m2
- Participants must be on stable renin-angiotensin system blocking treatment 4 weeks before start of study drug and throughout study duration.
- Able to understand the written participant information and give informed consent
Exclusion
- Non-diabetic kidney disease indicated by medical history and/or laboratory findings.
- eGFR\< 25 ml/min/1.73m2, dialysis or kidney transplantation.
- Previous diabetic ketoacidosis, except at debut.
- Dysregulated diabetes (HbA1c \> 85 mmol/mol)
- Decreased awareness or unawareness
- Pregnancy, lactating or with a wish of pregnancy within the next year
- Low carbohydrate diet
- Receiving therapy with an SGLT inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT inhibitor.
- New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment
- Myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
- The receipt of any investigational product 90 days prior to this trial
- Unable to participate in study procedures
- Any clinically significant disorder, except for conditions associated with type 1 diabetes, which in the Investigators opinion could interfere with the results of the trial
- Participation in another intervention study
- Exclusion criteria for MRI: known claustrophobia, known chronic lung disease, surgery within past 6 weeks or having foreign bodies of metal in the body (e.g. pacemaker, metal plates, metal screws)
- Recurrent urogenital infections.
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT06147232
Start Date
February 1 2025
End Date
May 1 2027
Last Update
January 27 2025
Active Locations (2)
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1
Steno Diabetes Center Copenhagen
Herlev, Denmark, 2730
2
Guy's and St Thomas NHS Trust
London, United Kingdom