NCT07594145

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for phase_2

Timeline
65mo left

Started Sep 2026

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

3.3 years

First QC Date

May 11, 2026

Last Update Submit

May 18, 2026

Conditions

Type 1 DiabetesT1D Diabetic Chronic Kidney DiseaseT1D Heart FailureCardio-renal Vascular Function and Failure

Keywords

Type 1 DiabetesT1DDiabetic Chronic Kidney DiseaseDKDHeart FailurePlatform Trial

Outcome Measures

Primary Outcomes (3)

  • Markers of Renal Health [Safety and Tolerability]

    The primary efficacy endpoints are measures of early (week 26) outcomes on markers of renal health, defined as the percent change from baseline to week 26 in UACR.

    26 weeks

  • Markes of Cardio Health [Safety and Tolerability]

    The primary efficacy endpoints are measures of early (week 26) outcomes on markers of cardio health as defined by the percent change from baseline to week 26 in NT-proBNP.

    26 weeks

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    The primary safety endpoints are defined as incidence of serious adverse events, adverse events and clinically significant abnormal laboratory tests.

    26 weeks

Secondary Outcomes (3)

  • Immediate Outcomes of Renal Health (week 6)

    20 weeks

  • Immediate Outcomes of Cardio Health (week 6)

    20 weeks

  • Immediate (week 6) and Early (week 26) Outcomes of Nephron Function Failure

    26 weeks

Study Arms (2)

Finerenone

EXPERIMENTAL

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.

Drug: Finerenone

Sotagliflozin

EXPERIMENTAL

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.

Drug: Sotagliflozin

Interventions

FinerenoneDRUG

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.

Also known as: KERENDIA
Finerenone
SotagliflozinDRUG

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.

Also known as: INPEFA
Sotagliflozin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of T1D, defined as hyperglycemia requiring treatment with insulin within one year from diagnosis or, if the onset was after age 35 years, documentation of the presence of hyperglycemia and one or more of the following:
  • presence of circulating T1D-associated autoantibodies, or
  • history of hospitalization for diabetic ketoacidosis, or
  • documented plasma C-peptide below the limit of detection with standard assay (with concurrent blood glucose \>100 mg/dL)
  • Aged 18-75 years, inclusive
  • T1D duration \>10 years
  • HbA1c: 7-10%
  • Meets one of the following, either
  • UACR \> 30 mg/dl with eGFR ≥ 60mL/min/1.73 m2 and receiving standard of care therapy for early DKD Stage 2, including renin angiotensin system blockade (RASB), unless contraindicated or not tolerated, or
  • Early (Stage B HF) defined as NT-proBNP \> 125 pg/mL
  • Willing and able to adhere to schedule of activities and protocol requirements, including written informed consent

You may not qualify if:

  • Diagnosis of Type 2 diabetes or monogenic forms of diabetes or diabetes secondary to pancreatic disease
  • Use of any active platform study therapies outside study assignment within 2 months prior to screening. See Appendix A for active therapy arms.:
  • Use of GLP-1 receptor agonists if in use for less than 1 month and/or not on stable dose for at least 2 weeks at screening
  • Use of aldosterone inhibitors within 2 months prior to screening
  • Immunosuppressive medications within 3 months prior to screening
  • Systolic BP\>160 or diastolic BP \>95 mmHg at screening
  • History of ≥3 severe hypoglycemic events requiring third-party assistance for correction within 3 months prior to screening
  • Evidence of either of the following:
  • History of diabetic ketoacidosis (DKA) or non-ketotic hyperosmolar state within 3 months prior to screening, or
  • \>1 episode of DKA or non-ketotic hyperosmolar state within 12 months prior to screening
  • Serum potassium \> 5 mmol/L at screening
  • Absolute neutrophil count \< 2.0 × 109 per L at screening
  • Platelet count \< 120 × 109 per L at screening
  • Known active tuberculosis, HIV, or hepatitis B or C at screening
  • Current or past history of decompensated cirrhosis (defined as variceal bleeding, ascites or hepatic encephalopathy), and/or known diagnosis of cirrhosis based on liver biopsy, imaging, or elastography, and/or AST or ALT \>2 times upper limit of normal, and/or total bilirubin \>1.3 times upper limit of normal at screening
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Heart Failure

Interventions

finerenone(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Rodica Busui, MD, PhD

    Oregon Health and Science University

    STUDY CHAIR

Central Study Contacts

Laura Nguyen

CONTACT

(971) 509-4222nguyelau@ohsu.edu

Aly Carlson

CONTACT

(971) 610-3005carlsaly@ohsu.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A platform for personalized medicine where study participants will be adjudicated to specific treatment arms matched by their unique biomarker profiles.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Trial Chair and Principal Investigator at OHSU

Study Record Dates

First Submitted

May 11, 2026

First Posted

May 18, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2031

Last Updated

May 20, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

A limited dataset along with other study related materials (i.e., protocol, consent template, etc.) will be shared with other researchers/investigators at other institutions such as the University of Michigan via a data use agreement initiated by the primary site, Oregon Health \& Science University.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The sharing of information will be available as soon as both institutions sign the data use agreement for a limited dataset. However, the sharing of protocols and consent form language are currently being shared as both institutions are collaborating to draft these documents. This collaborating is facilitated by a subaward contract between two institutions.
Access Criteria
Only study personnel working on the study will have access to study related information. All information is kept on secure share drives at each respective institution and access is only possible if the personnel is an employee with institutional specific credentials to securely log in.

Locations

US(2)