NCT06560801 Dapagliflozin on Renal Morphology and Renal Perfusion in Patients One Year After Kidney Transplantation
| NCT ID | NCT06560801 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Erlangen-Nürnberg Medical School |
| Condition | Chronic Kidney Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2023-07-28 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 48 participants in total. It began in 2023-07-28 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this study is to observe the mechanisms of dapagliflozin on the renal interstitial tissue and renal perfusion. For this purpose, renal transplanted patients as an excellent model of CKD and high cardiovascular risk (similar to patients in DAPA-CKD study) are included in this study. The objectives of the study are to analyze the effects of dapagliflozin on renal morphology and renal perfusion in patients with impaired renal function one year after kidney transplantation. This is a randomized (1:1), single centre clinical study. Each patient will be randomly assigned in an unblinded fashion to 10 mg Dapagliflozin or not 9 months after transplantation. At least 48 patients will be randomized and included. The routine renal biopsy taken one year after kidney transplantation will allow us to determine the morphological integrity of peritubular fibroblasts, interstitial inflammatory cell density and investigate markers of inflammation, oxidative stress and nitic oxide synthase expression (iNOS).
Eligibility Criteria
Inclusion Criteria: * Female and male patients aged between 18 and 75 years * Patients with renal transplant having a stable eGFR, who are in stable condition, 9 months after transplantation, irrespective of their diabetes status * Females of child bearing potential must be using adequate contraceptive precautions * Females of childbearing potential or within two years of the menopause must have a negative urine pregnancy test at screening visit * Informed consent (§ 40 Abs. 1 Satz 3 Punkt 3 AMG) has to be given in written form Exclusion Criteria: * Type 1 diabetes mellitus. * HbA1c \> 10% * Use of SGLT-2 inhibitor within the past 2 months * Any history of stroke, transient ischemic attack, instable angina pectoris, or myocardial infarction within the last 3 months prior to study inclusion. * eGFR \<25 ml/min/1.73m² (CKD-EPI Formula). * Uncontrolled arterial hypertension (RR \> 180/110 mmHg). * Congestive heart failure (CHF) NYHA stage IV. * Recurrent urinary tract infections (bacterial or fungal) * Severe disorders of the gastrointestinal tract or other diseases which interfere the pharmacodynamics and pharmacokinetics of the drug. * Significant laboratory abnormalities such as SGOT or SGPT levels more than 5 x above the upper limit of normal range. * Antihypertensives are allowed but should be kept stable throughout the study period. * Statins and other antihyperlipidemic drugs are allowed but should be kept stable throughout the study period. * Drug or alcohol abusus * Pregnant or breast-feeding patients * Patients with contraindications to MRI
Frequently Asked Questions
Who can join the NCT06560801 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Chronic Kidney Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06560801 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06560801 currently recruiting?
Yes, NCT06560801 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Erlangen-Nürnberg Medical School to inquire about joining.
Where is the NCT06560801 trial being conducted?
This trial is being conducted at Erlangen, Germany.
Who is sponsoring the NCT06560801 clinical trial?
NCT06560801 is sponsored by University of Erlangen-Nürnberg Medical School. The trial plans to enroll 48 participants.
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