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Taking people in GermanyPhase 4

Tests dapagliflozin in kidney transplant patients with impaired kidney function

Tests dapagliflozin in adults with chronic kidney disease one year after kidney transplant.

Key facts

Who runs it
Universitaetsklinikum Erlangen AöR
Where
Erlangen, GermanySee the site
Registry title
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
Status
Recruiting
Phase
Phase 4
People taking part
48 people, planned
Started
3 Jul 2023
Planned end
31 Dec 2025
Type of study
Interventional
Record updated
18 September 2024

Who can take part

AI summary

From the trial's eligibility criteria. 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% (86 mmol/mol)
  • 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

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • 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)
  • Antihypertensives are allowed but should be kept stable throughout the study period
  • Pregnant or breast-feeding patients
  • Patients with contraindications to MRI

Where in Germany

  • Universitaetsklinikum Erlangen AöRErlangen, GermanyTaking people

About the trial

What the trial wants to find out

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests dapagliflozin in kidney transplant patients with impaired kidney functionGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
18 September 2024