Kidney FailurePhase 3NCT03627013
Custodiol-N Solution Compared With Custodiol Solution in Organ Transplantation (Kidney, Liver and Pancreas)
A Phase 3 study testing Custodiol-N Solution and Custodiol HTK Solution in people with Kidney Failure and Liver Failure, Chronic, run by Dr. F. Köhler Chemie GmbH at 4 sites in Austria.
Trial summary
Synopsis Title of Study A prospective, randomized, single blind multicentre phase III study on organ preservation with Custodiol-N compared with Custodiol solution in organ transplantation (kidney, liver and pancreas) Protocol number: CL-N-KLP-TX-III/07-AT/17 Trial design The study design is a prospective, randomized… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Liver Failure, Chronic, Kidney-Pancreas Failure
- What is being tested?
- Custodiol-N Solution and Custodiol HTK Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 4 sitesAustria
- Study dates
- 23 May 2019to 30 Sep 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All organs (kidney, combined kidney - pancreas and liver) Donor criteria
- For All patients undergoing deceased donation:
- deceased adult (≥18 years) donors fulfilling the criteria for organ donation
- For All patients undergoing living kidney donation:
- adult (≥18 years) living kidney donors fulfilling the criteria for organ donation
- Patient (recipient) criteria
Show all 11Show fewer
- recipients awaiting their transplant
- recipients ≥18 years
- recipients' signed informed consent before the transplantation Kidney / combined kidney - pancreas recipients
- n/a Liver recipient
- full organ transplantation
Who cannot join
- All organs (kidney, combined kidney - pancreas and liver) Donor criteria (not applicable for living kidney donors)
- - donors whose organs are all allocated out of retrieving study center
- general refusal of organ donation
- donation after cardiac death (DCD) Patient (recipient) criteria
- pregnant or lactating patients
- recipients participating in any interventional study (e.g. another study involving compound/interventions aimed at the reduction of preservation and / or ischemia / reperfusion injury)
Show all 14Show fewer
- all combined allocations other than pancreas and kidney
- Kidney / combined kidney -pancreas recipient
- double kidney transplantation
- pancreas retransplantation
- machine perfusion According to the KDIGO-Guidelines (2009) all patients with PRA >0% are only included in the living donation setting.
- Liver recipient
- retransplantation
- machine perfusion
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Austria4 sites, 4 recruiting
- Recruiting
Medical University Graz
Graz
Stiegler
- Recruiting
Medical University Innsbruck
Innsbruck
Schneeberger
- Recruiting
Ordensklinikum Linz
Linz
Biebl
- Recruiting
Medical University Vienna
Vienna
Berlakovich
About this study
Official title: A Prospective, Randomized, Single Blind, Multicentre Phase III Study on Organ Preservation With Custodiol-N Solution Compared With Custodiol Solution in Or-gan Transplantation (Kidney, Liver and Pancreas)
Synopsis Title of Study A prospective, randomized, single blind multicentre phase III study on organ preservation with Custodiol-N compared with Custodiol solution in organ transplantation (kidney, liver and pancreas)
Protocol number: CL-N-KLP-TX-III/07-AT/17
Read more
Trial design The study design is a prospective, randomized, single blind, multicentre, phase III comparison study of organ perfusion intended to demonstrate non-inferiority of Custodiol-N against Custodiol in organ transplantation of kidney, combined kidney-pancreas and liver.
Intended duration of study The overall duration for the trial is expected to be approximately 30 months. The du-ration of the trial for each subject is expected to be 3 months (transplantation and a follow-up period of 90 days).
Purpose of the study
The objective of this investigation is to demonstrate non-inferiority of graft preservation with Custodiol-N compared to Custodiol with respect to both graft function and injury after transplantation of kidney, liver or combined kidney-pancreas.
Patient selection The study population will be selected from patients who will undergo kidney, liver or combined kidney-pancreas transplantation. Patients of each gender will be included in the study.
Planned number of patients (recipients)
In total N=362 including:
Kidney 242 (including approx. 30 combined kidney-pancreas)
Liver 120
- Being tested
- Custodiol-N Solution, Custodiol HTK Solution
- Medical subject headings
- Renal Insufficiency, End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custodiol-N SolutionDrug
Perfusion
Custodiol HTK SolutionDrug
Perfusion
| Study group | Role | What they receive |
|---|---|---|
| Kidney Custodiol-N | Experimental | Not described Receives: Drug: Custodiol-N Solution |
| Kidney Custodiol | Active comparator | Not described Receives: Drug: Custodiol HTK Solution |
| Liver Custodiol-N | Experimental | Not described Receives: Drug: Custodiol-N Solution |
| Liver Custodiol | Active comparator | Not described Receives: Drug: Custodiol HTK Solution |
| Kidney/Pancreas Custodiol-N | Experimental | Not described Receives: Drug: Custodiol-N Solution |
| Kidney/Pancreas Custodiol | Active comparator | Not described Receives: Drug: Custodiol HTK Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney: - delayed graft function: Dialysis requirement during the first week af-ter transplantation
Measured: 7 days
Liver: - area under the curve (AUC) GPT (ALT) after transplantation during 7 days (minimum 1 measurement per day)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start23 May 2019
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 362 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. F. Köhler Chemie GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627013
- Sponsor's protocol ID
- CL-N-KLP-TX-III/07-AT/17
- Other IDs
- 2017-002198-20, 2017
- Status last verified
- Sep 2025
- First submitted
- 8 Aug 2018
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Single Blind, Multicentre Phase III Study on Organ Preservation With Custodiol-N Solution Compared With Custodiol Solution in Or-gan Transplantation (Kidney, Liver and Pancreas)
- ClinicalTrials.gov ID
- NCT03627013
- Acronym / sponsor ID
- CL-N-KLP-TX-III/07-AT/17
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 362 participants (estimated)
- Lead sponsor
- Dr. F. Köhler Chemie GmbHIndustry (pharma, biotech, devices)
- Study start
- 23 May 2019 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 13 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Synopsis Title of Study A prospective, randomized, single blind multicentre phase III study on organ preservation with Custodiol-N compared with Custodiol solution in organ transplantation (kidney, liver and pancreas)
Protocol number: CL-N-KLP-TX-III/07-AT/17
Trial design The study design is a prospective, randomized, single blind, multicentre, phase III comparison study of organ perfusion intended to demonstrate non-inferiority of Custodiol-N against Custodiol in organ transplantation of kidney, combined kidney-pancreas and liver.
Intended duration of study The overall duration for the trial is expected to be approximately 30 months. The du-ration of the trial for each subject is expected to be 3 months (transplantation and a follow-up period of 90 days).
Purpose of the study
The objective of this investigation is to demonstrate non-inferiority of graft preservation with Custodiol-N compared to Custodiol with respect to both graft function and injury after transplantation of kidney, liver or combined kidney-pancreas.
Patient selection The study population will be selected from patients who will undergo kidney, liver or combined kidney-pancreas transplantation. Patients of each gender will be included in the study.
Planned number of patients (recipients)
In total N=362 including:
Kidney 242 (including approx. 30 combined kidney-pancreas)
Liver 120
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Kidney Custodiol-N | Experimental | Drug: Custodiol-N Solution |
| Kidney Custodiol | Active comparator | Drug: Custodiol HTK Solution |
| Liver Custodiol-N | Experimental | Drug: Custodiol-N Solution |
| Liver Custodiol | Active comparator | Drug: Custodiol HTK Solution |
| Kidney/Pancreas Custodiol-N | Experimental | Drug: Custodiol-N Solution |
| Kidney/Pancreas Custodiol | Active comparator | Drug: Custodiol HTK Solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- All organs (kidney, combined kidney - pancreas and liver) Donor criteria
- deceased adult (≥18 years) donors fulfilling the criteria for organ donation
- adult (≥18 years) living kidney donors fulfilling the criteria for organ donation
- Patient (recipient) criteria
- recipients awaiting their transplant
Key exclusion criteria (14 listed)
- All organs (kidney, combined kidney - pancreas and liver) Donor criteria (not applicable for living kidney donors)
- - donors whose organs are all allocated out of retrieving study center
- general refusal of organ donation
- donation after cardiac death (DCD) Patient (recipient) criteria
- pregnant or lactating patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Custodiol-N SolutionPerfusion | Drug | Kidney Custodiol-N, Kidney/Pancreas Custodiol-N, Liver Custodiol-N |
| Custodiol HTK SolutionPerfusion | Drug | Kidney Custodiol, Kidney/Pancreas Custodiol, Liver Custodiol |
Primary outcome
Kidney: - delayed graft function: Dialysis requirement during the first week af-ter transplantation
Time frame: 7 days
Liver: - area under the curve (AUC) GPT (ALT) after transplantation during 7 days (minimum 1 measurement per day)
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Custodiol-N Solution and Custodiol HTK Solution in people with Kidney Failure and Liver Failure, Chronic, run by Dr. F. Köhler Chemie GmbH at 4 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Astrid Friedel (+4332638578017, astrid.friedel@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kidney: - delayed graft function: Dialysis requirement during the first week af-ter transplantation (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.