BridgeMD
Personalized Treatment Optimization for Kidney Health in Type 2 Diabetes: A Remote Trial with Empagliflozin and Finerenone
EU CTIS ID: 2023-508585-15-00
What this study is testing
To determine the feasibility and advantages of remote clinical trial conduct with multiple medications in patients with type 2 diabetes and elevated albuminuria.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥18 years
- Diagnosis of type 2 diabetes
- UACR >4.5 mg/mmol (>40 mg/g) and ≤300 mg/mmol (≤2655 mg/g)
- eGFR ≥25 mL/min/1.73m^2
- On a stable dose of an ACE inhibitor/ARB if tolerated
- Willing to sign informed consent
You likely can't join if
- Diagnosis of type 1 diabetes
- Unstable or rapidly progressing renal disease
- Active malignancy
- Suggestive evidence of adrenal insufficiency
- History of severe hypersensitivity or contraindications to any SGLT2 inhibitor or MRA
- Uncontrolled arterial hypertension (mean sitting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg)
See the full eligibility criteria
Who can join
- Age ≥18 years
- Diagnosis of type 2 diabetes
- UACR >4.5 mg/mmol (>40 mg/g) and ≤300 mg/mmol (≤2655 mg/g)
- eGFR ≥25 mL/min/1.73m^2
- On a stable dose of an ACE inhibitor/ARB if tolerated
- Willing to sign informed consent
- Proficiency in the Dutch language
What rules you out
- Diagnosis of type 1 diabetes
- Unstable or rapidly progressing renal disease
- Active malignancy
- Suggestive evidence of adrenal insufficiency
- History of severe hypersensitivity or contraindications to any SGLT2 inhibitor or MRA
- Uncontrolled arterial hypertension (mean sitting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg)
- Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following: History of active inflammatory bowel disease within the last 6 months; Major gastrointestinal tract surgery as decided by the physician; Pancreatitis within the last 6 months; Gastrointestinal ulcers and/or bleeding within the last 6 months; Evidence of urinary obstruction or difficulty in voiding at screening
- Participation in any clinical trial within 3 months prior to initial dosing
- Donation or loss of ≥400 mL of blood within 8 weeks prior to initial dosing
- Confirmed lactose intolerance demonstrated with a lactose intolerance test
- History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during screening or according to investigator’s assessment
- Already being treated with any SGLT2 inhibitor or MRA
- History of noncompliance to medical regimens or unwillingness to comply with the study protocol
- Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study
- Women of childbearing potential (WOCBP): WOCBP who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of the study drug in such a manner the risk of pregnancy is minimized; WOCBP must have a negative serum or urine pregnancy test result (minimum sensitivity 25 IU/L or equivalent of HCG) at screening. WOCBP comprises women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who are not post-menopausal. The following women are NOT considered as WOCBP: Women using the following methods to prevent pregnancy: oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as intrauterine devices or barrier methods (diaphragm, condoms, spermicides); Women who are practicing abstinence; Women who have a partner who is sterile (e.g. due to vasectomy). Post-menopause is defined as: Women who have had amenorrhea for >12 consecutive months (without another cause) and who have a documented serum follicle-stimulating hormone (FSH) level >35 mIU/mL; Women who have irregular menstrual periods and a documented serum FSH level >35 mIU/mL; Women who are taking hormone replacement therapy (HRT)
- Unable to monitor blood pressure or body weight or handle digital technologies
- Heart failure NYHA Class II to IV requiring MRA treatment
- Acute coronary syndrome event within 6 months
- Serum potassium >5 mmol/L after repeated measurement
- Evidence of severe hepatic impairment determined by any of one: ALT or AST values exceeding 3 times ULN, a history of hepatic encephalopathy, a history of oesophageal varices, or a history of portocaval shunt
- Active pregnancy or breastfeeding
- History of kidney or liver transplant
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.