Overview
Sponsor-declared trial summary
Chronic Kidney Disease (CKD)
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
Key facts
- Sponsor
- Universitaetsklinikum Erlangen AöR
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 3 Jul 2023 → ongoing
- Decision date (initial)
- 2024-09-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-517885-40-00
- EudraCT number
- 2023-000042-42
- WHO UTN
- U1111-1286-8400
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
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
Conditions and MedDRA coding
Chronic Kidney Disease (CKD)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | LLT | 10076410 | Chronic kidney disease stage 3 | 10038359 |
| 23.1 | LLT | 10076411 | Chronic kidney disease stage 4 | 10038359 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 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
Exclusion criteria 15
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Forxiga 10 mg film-coated tablets
PRD2434984 · Product
- Active substance
- Dapagliflozin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 840 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BK01 — -
- Marketing authorisation
- EU/1/12/795/006
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaetsklinikum Erlangen AöR
- Sponsor organisation
- Universitaetsklinikum Erlangen AöR
- Address
- Maximiliansplatz 2, Innenstadt Innenstadt
- City
- Erlangen
- Postcode
- 91054
- Country
- Germany
Scientific contact point
- Organisation
- Universitaetsklinikum Erlangen AöR
- Contact name
- Dr. med. Dennis Kannenkeril
Public contact point
- Organisation
- Universitaetsklinikum Erlangen AöR
- Contact name
- Dr. med. Dennis Kannenkeril
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 48 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2023-07-03 | 2023-07-28 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Dapa-Tx_Protocol_redacted | 1.1 |
| Recruitment arrangements (for publication) | Blank_document | NA |
| Subject information and informed consent form (for publication) | L1_Dapa-Tx_ICF_adult_redacted | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Forxiga | NA |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-06 | Germany | Acceptable 2024-09-12
|
2024-09-18 |