Status:
RECRUITING
Dapagliflozin on Renal Morphology and Renal Perfusion in Patients One Year After Kidney Transplantation
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Conditions:
Chronic Kidney Diseases
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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...
Detailed Description
Chronic kidney disease (CKD) has a high prevalence globally and is a global health concern. CKD is associated with increased risks of cardiovascular morbidity, mortality and decreased quality of life ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06560801
Start Date
July 28 2023
End Date
December 31 2026
Last Update
August 19 2024
Active Locations (1)
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1
Clinical Research Center (CRC)
Erlangen, Bavaria, Germany, 91054