Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruitment ended
Participants planned
44
Countries
1
Sites
1
Autosomal dominant polycystic kidney disease
Exploring the safety of empagliflozin for kidney growth in ADPKD patients.
Key facts
- Sponsor
- Medizinische Hochschule Hannover
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 27 Jun 2024 → ongoing
- Decision date (initial)
- 2024-03-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Boehringer Ingelheim
External identifiers
- EU CT number
- 2023-505890-34-00
- WHO UTN
- U1111-1301-4333
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Safety
Exploring the safety of empagliflozin for kidney growth in ADPKD patients.
Conditions and MedDRA coding
Autosomal dominant polycystic kidney disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10032607 | Other specified cystic kidney disease | 10010331 |
| 20.0 | LLT | 10011771 | Cystic kidney disease | 10010331 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Male and female patients ≥ 18 of age
- Screening eGFR ≥ 25 and ≤ 90 mL/min/1.73 m2 if age ≥ 18 and ≤50 years or Screening eGFR ≥ 25 and ≤ 65 mL/min/1.73 m2 if age > 50 years
- ADPKD diagnosed by unified criteria (combination of family history, ultrasound, MRI/CT, genotyping as needed)
- Mayo Class I C, D, E
- Patients with and without tolvaptan use will be included. Patients with tolvaptan use will be included if tolvaptan has been taken for ≥ 3 months at study entry.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
- Evidence of signed written informed consent
Exclusion criteria 12
- Kidney or any other solid organ transplant recipient
- Currently receiving SGLT2-inhibitor
- Concomitant treatment with steroids or any other immunosuppressive agent
- Hypersensitivity to the active principle (Empagliflozin) or any of the excipients (e.g. lactose)
- Ketoacidosis (laboratory based) in the past 5 years
- Type 1 diabetes mellitus
- Uncontrolled urinary tract- or genital infections
- Inability to fully understand the possible risks and benefits related to study participation
- Inability to undergo MRI exam (e.g. implanted medical devices)
- Women who are pregnant or breastfeeding
- Unwilling to practice acceptable methods of birth control during study participation
- Participation in another clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior to enrolment)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Relative change from baseline total kidney volume (TKV) to month 18 of treatment (%/year).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Jardiance 10 mg film-coated tablets
PRD1594848 · Product
- Active substance
- Empagliflozin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 5.46 g gram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- A10BK03 — -
- Marketing authorisation
- EU/1/14/930/010
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- EU/1/14/930/010-018 (bulk tablets) is used in this clinical trial.
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Medizinische Hochschule Hannover
- Sponsor organisation
- Medizinische Hochschule Hannover
- Address
- Carl-Neuberg-Strasse 1, Gross Buchholz Gross Buchholz
- City
- Hanover
- Postcode
- 30625
- Country
- Germany
Scientific contact point
- Organisation
- Medizinische Hochschule Hannover
- Contact name
- Klinik für Nieren-u. Hochdruckerkrankungen
Public contact point
- Organisation
- Medizinische Hochschule Hannover
- Contact name
- Klinik für Nieren-u. Hochdruckerkrankungen
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 44 | 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 | 2024-06-27 | 2024-06-27 | 2025-09-30 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-20 | Germany | Acceptable 2024-03-04
|
2024-03-05 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-30 | Germany | Acceptable 2024-03-04
|
2025-09-30 |