Precision T1D Platform - New Therapies for Cardio-Renal Complications

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Oregon Health and Science University
Study ID
NCT07594145
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Cardio-renal Vascular Function and Failure
  • T1D Diabetic Chronic Kidney Disease
  • T1D Heart Failure
  • Type 1 Diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Finerenone — DRUG
    Each treatment arm will be a different unique drug. There will be no crossing over of participants between arms. Each participant that is adjudicated to their treatment arm will remain on that arm for the duration of the study through study completion.
  • Sotagliflozin — DRUG
    Each treatment arm will be a different unique drug. There will be no crossing over of participants between arms. Each participant that is adjudicated to their treatment arm will remain on that arm for the duration of the study through study completion.

Study Details

Breakthrough T1D has awarded support for a joint University of Michigan-Oregon Health \& Science University Center of Excellence (CoE) to address cardio-renal complications in T1D. The overarching hypothesis of the CoE is that individuals with T1D have unique endophenotypes determining their progression towards cardio-renal end organ damage. Defining the underlying molecular programs in T1D endophenotypes provides the rationale for testing existing or new drug candidates in mechanistic trials targeting T1D cardio-renal complications by matching endophenotypes to targeted therapies.

Key Dates

Start date
Sep 1, 2026
Status verified
May 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2031

Study Design

Enrollment
57 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Finerenone
    Study participants with biomarker profiles showing a match for finerenone will be adjudicated to this treatment arm. The clinically recommended dose for finerenone based on manufacturer guidelines is 20 mg once daily (oral) if screening eGFR is ≥60 mL/min/1.73 m2.
  • Experimental: Sotagliflozin
    Study participants with biomarker profiles that match with sotagliflozin will be adjudicated to this treatment arm. The clinically recommended dose of sotagliflozin is 200 mg per the manufacturer guidelines. The dose of 200 mg has a lower DKA risk and similar kidney benefits to the higher doses.

Primary Outcome Measure

Markers of Renal Health [Safety and Tolerability] [ Time Frame: 26 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Hailey Desmond, MS
[email protected]
(734) 764-6955
Lynn Ang, MD (PRINCIPAL_INVESTIGATOR)
Matthias Kretzler, MD (SUB_INVESTIGATOR)
Oregon Health & Science UniversityPortlandOregon97239
Laura Nguyen
[email protected]
971-509-4222
Aly Carlson
971-610-3005
Rodica Busui, MD, PhD (PRINCIPAL_INVESTIGATOR)
Jonathan Purnell, MD (SUB_INVESTIGATOR)
David Ellison, MD (SUB_INVESTIGATOR)
Brian Davidson, MD (SUB_INVESTIGATOR)
Kristin Childress, MD, MPH (SUB_INVESTIGATOR)

Find similar trials in Ann Arbor, MI

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of Michigan· Ann Arbor, MIOregon Health & Science University· Portland, OR

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