Real-World study tracks kidney drug use across eastern europe
NCT ID NCT06203704
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how doctors in seven Central Eastern European countries prescribe dapagliflozin for chronic kidney disease in routine care. Researchers reviewed medical records of about 1,090 adults to understand who gets the drug and what happens over the next year. The goal was to gather real-world insights, not to test a new treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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1,086 people
The number who actually took part.
- Started
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Dec 2023
- Finished
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Sep 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population will consist of adult patients with CKD who meet the country-specific label for dapagliflozin as treatment for CKD across CEE. Patients newly initiated on treatment with dapagliflozin for CKD will be eligible for enrolment by physicians from both outpatient and inpatient settings.
- Ages
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18 to 130 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adult patients (age ≥18 years) at the time of dapagliflozin start 2. Patient receives treatment with dapagliflozin for CKD in accordance with the dapagliflozin product label and local dapagliflozin reimbursement criteria for CKD Note: CKD diagnosis is based on the following KDIGO criteria \[KDIGO 2012\] that defines CKD as abnormalities of kidney structure or function, present for \>3 months, with implications for health and at least one of the following criteria: * AER ≥30 mg/24 hours; * ACR ≥30 mg/g (≥3 mg/mmol); * eGFR \<60 ml/min/1.73 m2. 3. Signed and dated informed consent prior to enrollment in the study. Exclusion Criteria: 1. Diagnosed with type 1 diabetes \[ICD-10 codes E10 and O24.0\] at any time before index date. 2. Diagnosed with gestational diabetes mellitus \[ICD-10 code O24.419\] at any time before index date. 3. Patient is enrolled less than 30 days or more than 90 days, following initiation of dapagliflozin. 4. Prior treatment (at any time before index date) with dapagliflozin or other SGLT-2i 5. Enrolment in a clinical trial that includes specific treatments as investigational medicinal product on or 3 months before index date 6. Renal transplant at any time before index date 7. End stage renal disease (eGFR \<15 ml/min/1.73m2) on index date 8. Chronic dialysis on or at any time before index date
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site
Plovdiv, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Zagreb, Croatia
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Békéscsaba, Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Gödöllő, Hungary
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Karcag, Hungary
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Kecskemét, Hungary
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Miskolc, Hungary
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Nagykanizsa, Hungary
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Nyíregyháza, Hungary
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Pécs, Hungary
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Siófok, Hungary
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Szeged, Hungary
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Szombathely, Hungary
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Veszprém, Hungary
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Bialystok, Poland
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Bolesławiec, Poland
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Bydgoszcz, Poland
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Choszczno, Poland
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Czarnków, Poland
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Katowice, Poland
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Krakow, Poland
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Lodz, Poland
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Olsztyn, Poland
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Opole, Poland
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Sieradz, Poland
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Szczecin, Poland
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Środa Wielkopolska, Poland
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Węgrów, Poland
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Wroclaw, Poland
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Zielona Góra, Poland
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Żywiec, Poland
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Bistriţa, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Galati, Romania
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Iași, Romania
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Oradea, Romania
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Reşiţa, Romania
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Satu Mare, Romania
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Târgu Mureş, Romania
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Timișoara, Romania
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Belgrade, Serbia
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Brežice, Slovenia
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Cerknica, Slovenia
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Menges, Slovenia
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Portorož, Slovenia
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Ptuj, Slovenia
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Radlje ob Dravi, Slovenia
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Ruše, Slovenia
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Sevnica, Slovenia
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Škofja Loka, Slovenia
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Zagorje, Slovenia
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Other studies related to the condition(s) this trial covers.
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