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Clinical validation study of urinary clusterin and EGF in patients with chronic kidney disease
EU CTIS ID: 2023-507449-27-00
What this study is testing
To compare the effect of a biomarker response guided treatment approach versus guideline care on 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 and ≤ 75 years
- eGFR ≥ 25 mL/min/1.73m2
- UACR > 100 mg/g (10 mg/mmol) in two consecutive first-morning void urine samples. UACR 80-100 mg/g is accepted if historical measurements are above 100 mg/g and if it cannot be explained by any new treatment.
- Participants must be on a maximum tolerated dose of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) for at least four weeks before enrollment.
- Ability to communicate with the study staff and understand and sign the informed consent.
You likely can't join if
- Age < 18 years or > 75 years
- Lupus nephritis or ANCA-associated vasculitis, or any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening
- Kidney transplant
- Dialysis
- Addison's disease
- Concomitant treatment with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, cobicistat, clarithromycin)
See the full eligibility criteria
- Age ≥ 18 and ≤ 75 years
- eGFR ≥ 25 mL/min/1.73m2
- UACR > 100 mg/g (10 mg/mmol) in two consecutive first-morning void urine samples. UACR 80-100 mg/g is accepted if historical measurements are above 100 mg/g and if it cannot be explained by any new treatment.
- Participants must be on a maximum tolerated dose of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) for at least four weeks before enrollment.
- Ability to communicate with the study staff and understand and sign the informed consent.
- Age < 18 years or > 75 years
- Lupus nephritis or ANCA-associated vasculitis, or any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening
- Kidney transplant
- Dialysis
- Addison's disease
- Concomitant treatment with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, cobicistat, clarithromycin)
- Idiopathic pulmonary fibrosis
- Type 1 diabetes
- Known or suspected hypersensitivity to the study medications or related products
- Presence or history of malignant neoplasms (except basal cell skin cancer or squamous cell skin cancer) within 5 years before screening.
- Any other history, condition, therapy, or uncontrolled intercurrent illness that could, as judged by the investigator, affect participant safety or compliance with study requirements.
- Eligible to receive at least two of three study treatments. Participants meeting two or more of the following criteria will be excluded: a. Potassium > 5.0 mmol/L b. Heart failure NYHA class III or IV or NT-proBNP > 600 pg/ml c. Not a candidate for treatment with an SGLT2 inhibitor, e.g., due to contraindications (according to the Forxiga SmPC) or previously experienced side effects from an SGLT2 inhibitor.
- A female who is pregnant, breastfeeding, or intends to become pregnant, or women of childbearing potential (WOCBP) who are not using highly effective contraceptive methods.
- A female who is pregnant, breastfeeding, or intends to become pregnant, or women of childbearing potential (WOCBP) who are not using highly effective contraceptive methods.
- Participant in another intervention study.
- NT-proBNP > 1200 pg/ml
- Severe peripheral or facial edema (according to the investigator's opinion)
- Diagnosis of unstable angina pectoris and/or myocardial infarction within the last six months.
- Already receiving treatment with two of the three study drugs (for example, an SGLT2 inhibitor and finerenone).
- Treatment with a potassium-sparing diuretic or a mineralocorticoid receptor antagonist, except for finerenone (e.g., spironolactone, eplerenone, or amiloride)
- Elevated Alanine Aminotransferase (ALT) > 3 x upper normal limit, autoimmune hepatitis, and/or severe hepatic impairment (including but not limited to a history of hepatic encephalopathy, a history of esophageal varices or a history of portocaval shunt.)
- Autosomal dominant or autosomal recessive polycystic kidney disease
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
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.