2024-517885-40-00RecruitingPhase 4
Randomized clinical study to analyse the effects of dapagliflozin on renal morphology and renal perfusion in patients with impaired renal function one year after kidney transplantation
Randomized clinical study to analyse the effects of dapagliflozin on renal morphology and renal perfusion in patients with impaired renal function one year after kidney transplantation
Source: EU CTIS (euclinicaltrials.eu) · Last updated 18 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The primary objective is to analyze the effect of dapagliflozin on 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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 6 Sept 2024
- Start date
- 3 Jul 2023
- Lead sponsor
- Universitaetsklinikum Erlangen AöR
- Diseases
- Chronic kidney disease
- EU CT number
- 2024-517885-40-00
- EudraCT number
- 2023-000042-42
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 48
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 75 with a kidney transplant and stable kidney function, about 9 months after the transplant. It tests dapagliflozin.
- Age
- 18 to 75 years
- Sex
- Women and men can join.
- Disease stage
- Kidney transplant with a stable eGFR, in stable condition, 9 months after transplantation. Diabetes status does not matter.
- Earlier treatment
- No SGLT-2 inhibitor in the past 2 months.
Main reasons for not taking part
- Type 1 diabetes
- Pregnant or breast-feeding
- eGFR below 25 ml/min/1.73m²
- HbA1c above 10%
- Stroke, transient ischemic attack, unstable angina or heart attack in the last 3 months
This trial only enrols participants who have had an organ transplant. The registry sentence this rests on: Patients with renal transplant having a stable eGFR, who are in stable condition, 9 months after transplantation, irrespective of their diabetes status
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Statins and other antihyperlipidemic drugs are allowed but should be kept stable throughout the study period
- Drug or alcohol abusus
- 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
Other illness
- Type 1 diabetes mellitus
- 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
Lab values
- Significant laboratory abnormalities such as SGOT or SGPT levels more than 5 x above the upper limit of normal range
- HbA1c > 10%
- eGFR <25 ml/min/1.73m² (CKD-EPI Formula)
Other
- Antihypertensives are allowed but should be kept stable throughout the study period
- Pregnant or breast-feeding patients
- Patients with contraindications to MRI
Who the study is looking for
- 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 has to be given in written form
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaetsklinikum Erlangen AöR | Erlangen | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.