Dapagliflozin for Chronic kidney disease (CKD) | Chronic kidney disease stage 3 | Chronic kidney disease stage 4

Inclusion criteria

• {"criterion_text":"- Female and male patients aged between 18 and 75 years\n- Patients with renal transplant having a stable eGFR, who are in stable condition, 9 months after transplantation, irrespective of their diabetes status\n- Females of child bearing potential must be using adequate contraceptive precautions\n- Females of childbearing potential or within two years of the menopause must have a negative urine pregnancy test at screening visit\n- Informed consent has to be given in written form"}

Exclusion criteria

• {"criterion_text":"- Type 1 diabetes mellitus\n- HbA1c > 10%\n- Use of SGLT-2 inhibitor within the past 2 months\n- Any history of stroke, transient ischemic attack, instable angina pectoris, or myocardial infarction within the last 3 months prior to study inclusion\n- eGFR <25 ml/min/1.73m² (CKD-EPI Formula)\n- Uncontrolled arterial hypertension (RR > 180/110 mmHg)\n- Congestive heart failure (CHF) NYHA stage IV\n- Recurrent urinary tract infections (bacterial or fungal)\n- Severe disorders of the gastrointestinal tract or other diseases which interfere the pharmacodynamics and pharmacokinetics of the drug\n- Significant laboratory abnormalities such as SGOT or SGPT levels more than 5 x above the upper limit of normal range\n- Antihypertensives are allowed but should be kept stable throughout the study period\n- Statins and other antihyperlipidemic drugs are allowed but should be kept stable throughout the study period\n- Drug or alcohol abusus\n- Pregnant or breast-feeding patients\n- Patients with contraindications to MRI"}

Primary endpoints

• {"endpoint_text":"- Renal morphology (e.g. integrity of peritubular fibroblasts (PDGFRα)), markers of inflammation (CD3, CD68, CD163) and oxidative stress (Nox1, 8-OHdG) in the interstitium assessed from the routine one year follow up biopsy of the renal transplant","definition_or_measurement_approach":"Assessed from the routine one-year follow-up biopsy of the renal transplant; analysis of renal morphology (e.g. integrity of peritubular fibroblasts (PDGFRα)), markers of inflammation (CD3, CD68, CD163) and oxidative stress (Nox1, 8-OHdG) in the interstitium."}

Germany

Earliest CTIS Part Ii Submission Date

06-09-2024

Latest Decision Or Authorization Date

18-09-2024

Processing Time Days

12

Number Of Sites

1

Number Of Participants

48

Primary sponsor

Full Name

Universitaetsklinikum Erlangen AöR

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany