Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
454
Countries
1
Sites
5
Rare and ultra-rare glomerulonephritis
Assessment of safety and effectiveness desmopressin used before percutaneous needle kidney biopsy for bleeding prevention.
Key facts
- Sponsor
- Medical University Of Bialystok
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 25 Aug 2022 → 1 Oct 2025
- Decision date (initial)
- 2024-12-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- Medical Research Agency
External identifiers
- EU CT number
- 2024-516270-30-00
- EudraCT number
- 2021-006647-99
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Prophylaxis, Safety
Assessment of safety and effectiveness desmopressin used before percutaneous needle kidney biopsy for bleeding prevention.
Secondary objectives 1
- Assessment of safety and effectiveness desmopressin used before percutaneous needle kidney biopsy for hospitalization time and AESI frequency.
Conditions and MedDRA coding
Rare and ultra-rare glomerulonephritis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10018364 | Glomerulonephritis | 100000004857 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- ≥ 18 years old
- Ability to provide Informed Consent
- Qualification by nephrologist to kidney biopsy in accordance to current standards - transplanted kidney biopsy is not allowed.
- Initial haemoglobin concentration > 8g/dl and PLT count >100 x103/µL
- Normal range of APTT and INR
- Blood pressure control defined as SBP<160 mmHg
- Permitted antiplatelet/antithrombotic drugs: acetylsalicylic acid and non-fractionated or low molecular weight heparin.
- No inflammation at the point of biopsy needle insertion
Exclusion criteria 9
- Initial sodium concentration <130mmol/l
- Pregnancy and breastfeeding
- Anaphylactic shock after desmopressin administration (medical history)
- Necessity of administration other anti-platelet / anti thrombotic drugs other than acetylsalicylic acid, non-fractionated heparin or low molecular weight heparin
- Decompensated Heart failure
- Von Willebrand disease (VWD) type II B
- As per Investigator opinion a medical situation which may lead to increased intracranial pressure (ICP)
- Hydronephrosis of the biopsied kidney
- Usage of any prohibited drug before screening: ASA in dosage > 75mg per day; Vitamin K antagonist (VKA); direct oral anticoagulants (DOAC); except situation when dosage of listed above drugs will be adjusted in accordance to protocol.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Efficacy primary outcome: Number of major and minor bleeding events in 24 h after the procedure which is defined as: • minor bleeding events: macroscopic haematuria; clinically silent hematoma in ultrasound in 24h after biopsy, decrease in haemoglobin concentration >20% in regards to initial values. • Major bleeding events: transfusion of red cells concentrate, embolisation, nephrectomy, bleeding related directly and indirectly death.
- Safety primary outcome: Hyponatremia 24 and 48 h after biopsy
Secondary endpoints 3
- Efficacy secondary outcome: Hospitalization time from kidney biopsy till discharge
- Efficacy secondary outcome: Cost-effectiveness analysis of desmopressin use
- Safety secondary outcome Frequency of AEs of special interest: • Tachycardia HR>100 BPM • Hypotension defined as SBP <90 mmHg or MAP <65 mgHg or a systolic blood pressure decrease of 40 mmHg. • Any thrombotic events
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Minirin, 4 mikrogramy/ml, roztwór do wstrzykiwań
PRD470401 · Product
- Active substance
- Desmopressin Acetate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 3 µg/Kg microgram(s)/kilogram
- Max total dose
- 3 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- H01BA02 — DESMOPRESSIN
- Marketing authorisation
- 8208
- MA holder
- FERRING GMBH
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- change of package
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
Medical University Of Bialystok
- Sponsor organisation
- Medical University Of Bialystok
- Address
- Ul. Jana Kilinskiego 1
- City
- Bialystok
- Postcode
- 15-089
- Country
- Poland
Scientific contact point
- Organisation
- Medical University Of Bialystok
- Contact name
- Second Department of Nephrology, Hypertensiology and Internal Medicine with Dialysis Unit
Public contact point
- Organisation
- Medical University Of Bialystok
- Contact name
- Second Department of Nephrology, Hypertensiology and Internal Medicine with Dialysis Unit
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| Scientia Research Institute Sp. z o.o. ORG-100047497
|
Bydgoszcz, Poland | Code 10, Code 11, Code 12, Interactive response technologies (IRT), Data management, E-data capture, Code 8, Code 9 |
| Cefea Sp. z o.o. S.K. ORG-100015378
|
Warsaw, Poland | Other |
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ended | 454 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Uniwersytecki Szpital Kliniczny W Bialymstoku
II Klinika Nefrologii, z Poddodziałem Leczenia Nadciśnienia Tętniczego i Oddziałem Dializoterapii, Ul. Marii Curie-Sklodowskiej 24a, 15-276, Bialystok
Wojewódzki Specjalistyczny Szpital Dziecięcy w Olsztynie im. Prof. dr Stanisława Popowskiego
Oddział Kliniczny Nefrologii, Hipertensjologii i Chorób Wewnętrznych, ul. Żołnierska 18 a, 10-561, Olsztyn
Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji
Klinika Chorób Wewnętrznych, Nefrologii i Transplantologii, Wołoska 137, 02-507, Warszawa
Uniwersyteckie Centrum Kliniczne
Klinika Nefrologii, Transplantologii i Chorób Wewnętrznych, Ul. Debinki 7, 80-952, Gdansk
SP ZOZ Szpital Uniwersytecki w Krakowie
Oddział Kliniczny Nefrologii, Dializoterapii, Transplantologii i Chorób Wewnętrznych, ul. M. Jakubowskiego 2, 30-688, Kraków
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 |
|---|---|---|---|---|---|
| Poland | 2022-08-25 | 2025-10-01 | 2022-08-25 | 2025-06-14 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-516270-30-00 redacted | 1.2 |
| Recruitment arrangements (for publication) | placeholder for transition | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults redacted | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Minirin | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2024-516270-30-00 redacted | 1.1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-08 | Poland | Acceptable 2024-12-02
|
2024-12-02 |