Overview
Sponsor-declared trial summary
CKD 5, Peritoneal Dialysis
The aim of the study is to determine if there is sufficient blood plasma and dialysate concentration of Cefepim after intraperitoneal application of Cefepim and to study the drugs pharmacodynamics and pharmacokinetics to assess the effectiveness after intraperitoneal application
Key facts
- Sponsor
- Noe LGA Gesundheit Region Mitte GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Chemical Phenomena [G02], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 1 May 2024 → 30 Oct 2025
- Decision date (initial)
- 2024-04-15
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Karl Landsteiner Privatuniversität · NÖ Landesgesundheitsagentur
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy, Bioequivalence, Pharmacokinetic
The aim of the study is to determine if there is sufficient blood plasma and dialysate concentration of Cefepim after intraperitoneal application of Cefepim and to study the drugs pharmacodynamics and pharmacokinetics to assess the effectiveness after intraperitoneal application
Conditions and MedDRA coding
CKD 5, Peritoneal Dialysis
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-507930-26-00 | PHARMACOKINETICS OF CEFEPIME AFTER INTRAPERITONEAL ADMINISTRATION VIA CYCLER-THERAPY IN APD PATIENTS WITHOUT PERITONITIS | Noe LGA Gesundheit Region Mitte GmbH |
| 2020-000865-18 | Pharmacokinetics of meropenem and aztreonam after intraperitoneal administration via cycler-therapy in APD patients without peritonitis |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Males or females over the age of 18
- APD regime has to be established for a minimum of 1 month
- For short nighttime dwells patient need to use a glucose-based PDF (1,36% and/or 2.27%) and Icodextrin for the long daytime dwell
- Preparedness and Compliance to the protocol
- Signed informed consent
Exclusion criteria 8
- Any form of systemic infection
- Any disease that might hinder proper study performance or puts the patient at risk
- Severe hepatic impairment (Child-Pugh Class C)
- Severe hepatic impairment (Child-Pugh Class C)
- Pregnancy or woman of childbearing potential not minded to use appropriate contraception during the time of the study
- Allergic or hypersensitive reactions against cephalosporins
- Hemoglobin below 9 g/dl
- BMI below 19 or above 35
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 4
- AUC
- Cmax
- Half-life (t1/2)
- Time to reach maximum drug concentration (tmax)
Secondary endpoints 3
- Ratios of AUC and Cmax of different compartments
- Time above the minimal inhibitory concentration T>MIC
- Ratio of AUC from 0 to 24 hours (AUC 0-24)/MIC
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Cefepim-MIP 1 g Pulver zur Herstellung einer Injektions- / Infusionslösung
PRD2422469 · Product
- Active substance
- Cefepime
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRA-ABDOMINAL USE
- Max daily dose
- 6 g gram(s)
- Max total dose
- 60 g gram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01DE01 — -
- Marketing authorisation
- 135975
- MA holder
- MIP PHARMA GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Noe LGA Gesundheit Region Mitte GmbH
- Sponsor organisation
- Noe LGA Gesundheit Region Mitte GmbH
- Address
- Dunant-Platz 1
- City
- St. Poelten
- Postcode
- 3100
- Country
- Austria
Scientific contact point
- Organisation
- Noe LGA Gesundheit Region Mitte GmbH
- Contact name
- Dominik Tüchler
Public contact point
- Organisation
- Noe LGA Gesundheit Region Mitte GmbH
- Contact name
- Dominik Tüchler
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 8 | 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 |
|---|---|---|---|---|---|
| Austria | 2024-05-01 | 2025-10-30 | 2024-05-08 | 2024-07-22 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_CRF_Tracking Document_V2_V3 EU CT 2023-509930-21-00 | 1 |
| Protocol (for publication) | D1_CRF_V3 EU CT 2023-509930-21-00 | 3 |
| Protocol (for publication) | D1_Protocol_V3 EU CT 2023-509930-21-00 | 3 |
| Protocol (for publication) | D1_Track Change Version_V2 to V3_RFI003_Protocol EU CT 2023-509930-21-00 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material informed consent sheet_V3 | 3 |
| Subject information and informed consent form (for publication) | L2_Track Change Version_V1 to V2_RFI002_Other subject information material informed consent sheet | 1 |
| Subject information and informed consent form (for publication) | L2_Track Change Version_V2 to V3_RFI004_Other subject information material informed consent sheet | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | G1_IMPD_Q Cefepim-MIP_1g | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis MS German EU CT_V2 2023-509930-21-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Tracking Document_V1_V2_Protocol synopsis MS German EU CT 2023-509930-21-00 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-12 | Austria | Acceptable 2024-04-09
|
2024-04-15 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-05 | Austria | Acceptable 2024-04-09
|
2024-08-05 |