The study investigates chronic kidney disease (CKD), a condition with persistently reduced kidney function. It aims to identify biomarkers that can predict disease progression and cardiovascular complications.
Conditions
Interventions
Group 1: Arm 1: CKD patients receiving SGLT2 and RAS inhibition
Patients with chronic kidney disease (eGFR 20–90 ml/min/1.73 m² and proteinuria) treated with a sodium-glucose cotransporter-2 (SGLT2) i
Sponsors
Universität des Saarlandes
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Age: Adults aged 18 years or older • Chronic kidney disease with one of the following criteria: • Estimated glomerular filtration rate (eGFR) between 20 and 45 ml/min/1.73 m² or • eGFR between 45 and 90 ml/min/1.73 m² and urine albumin-to-creatinine ratio (uACR) = 200 mg/g • Patients may be on existing treatment with ACE inhibitors or angiotensin receptor blockers (ARBs) • Patients may be included regardless of whether they are currently taking an SGLT2 inhibitor • Signed informed consent is required
Exclusion criteria
Exclusion criteria: Participants will be excluded if any of the following apply: • Age under 18 years • Previous kidney replacement therapy or known dialysis-dependent kidney failure • History of kidney transplantation • Current pregnancy • No written informed consent to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| What: Time to first occurrence of any of the following: – Initiation of maintenance dialysis (kidney failure) – Sustained = 40% decline in estimated glomerular filtration rate (eGFR) from baseline – Hospitalization due to heart failure – Cardiovascular death When: Continuously assessed over the entire observation period (baseline to month 24); reviewed at each study visit (month 0, 1, 3, 6, 12, 18, 24) How: – Clinical event documentation by study physicians – Review of hospital discharge letters, death certificates, dialysis records – eGFR calculated from serum creatinine using the CKD-EPI formula | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. What: Annual rate of change in eGFR (“chronic eGFR slope”) When: Calculated based on all available eGFR values from baseline to month 24 How: Serum creatinine measurements at each visit; eGFR derived via CKD-EPI; analysis via linear regression ? 2. What: Time to isolated progression of kidney disease (= 40% eGFR decline or dialysis) When: Continuously assessed throughout the study How: Laboratory diagnostics and clinical documentation ? 3. What: Recurrent hospitalizations due to heart failure When: Retrospectively reviewed at each visit (especially at months 6, 12, 18, and 24) How: Medical history, hospital records, contact with referring physicians if needed ? 4. What: All-cause hospitalizations When: Continuously tracked and queried at each visit How: Patient report, hospital documentation ? 5. What: Time to death from any cause When: Continuously monitored up to month 24 How: Reported by relatives, primary care physicians, or hospitals ? 6. What: Change in left ventricular ejection fraction (LVEF) from baseline to year 1–4 When: Baseline, and annually at months 12, 24, 36, and 48 How: Transthoracic echocardiography using biplane Simpson’s method; performed by trained study staff ? 7. What: Change in left atrial volume index (LASV-index, ml/m²) When: Baseline, and annually at months 12, 24, 36, and 48 How: Transthoracic echocardiography (apical 4- and 2-chamber view), indexed to body surface area ? 8. What: Change in left ventricular mass indexed to body surface area (LVM, g/m²) When: Baseline, and annually from year 1 to year 4 How: Echocardiographic assessment; calculated using Devereux formula and indexed to BSA ? Exploratory Outcomes: 9. What: Change in urinary and serum DKK3 levels (? between baseline and years 1–4) When: Baseline and at months 12, 24, 36, 48 How: uDKK3 and sDKK3 measured using ELISA (enzyme-linked immunosorbent assay) ? 10. What: | — |
Countries
Germany
Contacts
Public ContactStefan Neuhaus
Universitätsklinikum des Saarlandes
Outcome results
None listed