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)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Dr. Franz Koehler Chemie GmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]

Trial duration

7 May 2019 → ongoing

Decision date (initial)

2024-10-22

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-512444-29-00

EudraCT number

2017-002198-20

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

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 kidney-pancreas.

Secondary objectives 13

1. Kidney 1. Incidence of primary poor function (creatinine at 3 month: >250  mol/l)
2. Kidney 2. Serum creatinine, creatinine MDRD clearance, urea, and hemoglobin after 3 months
3. kidney 3. Requirement of dialysis until 3 month after transplantation
4. kidney 4. Biopsy proven rejections
5. Liver 1. Absolute peak LDH within 7 days after transplantation
6. liver 2. Moment (day) of peak GPT and peak LDH
7. liver 3. Serum bilirubin, GOT, GPT, LDH, total albumin and PT at 3 months
8. liver 4. Biliary complications: number of episodes of cholestasis, therapy for chol-angitis, episodes of biliary leakage and intrahepatic and/or extrahepatic biliary strictures
9. Pancreas 1. Insulin requirements on days 3 and 30 and after 3 months
10. pancreas 2. α-amylase, lipase, C-reactive protein (CRP) at 1 und 3 days
11. pancreas 3. C-peptide and HBA1c at day 30 and 3 months
12. pancreas 4. Pancreatic complications: graft pancreatitis, anastomotic leak, vascular com-plications (thrombosis, stenosis, bleeding)
13. pancreas 5. Fasting glucose at 3 months

Conditions and MedDRA coding

patients who will undergo kidney, liver or kidney-pancreatic transplantation

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Donor criteria - For All patients undergoing deceased donation: - deceased adult (≥18 years) donors fulfilling the criteria for organ donation
2. donor criteria - For All patients undergoing living kidney donation: - adult (≥18 years) living kidney donors fulfilling the criteria for organ donation
3. - recipients awaiting their transplant
4. - recipients ≥18 years
5. - recipients' signed informed consent before the transplantation
6. Liver recipient - full organ transplantation

Exclusion criteria 11

1. 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
2. - general refusal of organ donation
3. - donation after cardiac death (DCD)
4. - pregnant or lactating patients
5. recipients participating in any interventional study (e.g. another study involv-ing compound/interventions aimed at the reduction of preservation and/or is-chemia/reperfusion injury)
6. - all combined allocations other than pancreas and kidney
7. double kidney transplantation
8. - pancreas re-transplantation
9. - machine perfusion
10. According to the KDIGO-Guidelines (2009) all patients with PRA >0% are only included in the living donation setting.
11. Liver recipient - re-transplantation

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. kidney: delayed graft function has been picked as the main endpoint liver: The success of liver transplantation is determined by the area under the curve of GPT (ALT) measurements over the first 7 days after implantation (AUC)

Secondary endpoints 13

1. Kidney 1. Incidence of primary poor function (creatinine at 3 month: >250  mol/l)
2. Kidney 2. Serum creatinine, creatinine MDRD clearance, urea, and hemoglobin after 3 months
3. kidney 3. Requirement of dialysis until 3 month after transplantation
4. kidney 4. Biopsy proven rejections
5. 1. Absolute peak LDH within 7 days after transplantation
6. liver 2. Moment (day) of peak GPT and peak LDH
7. liver 3. Serum bilirubin, GOT, GPT, LDH, total albumin and PT at 3 months
8. liver 4. Biliary complications: number of episodes of cholestasis, therapy for chol-angitis, episodes of biliary leakage and intrahepatic and/or extrahepatic bil-iary strictures
9. Pancreas 1. Insulin requirements on days 3 and 30 and after 3 months
10. pancreas 2. α-amylase, lipase, C-reactive protein (CRP) at 1 und 3 days
11. pancreas 3. C-peptide and HBA1c at day 30 and 3 months
12. pancreas 4. Pancreatic complications: graft pancreatitis, anastomotic leak, vascular complications (thrombosis, stenosis, bleeding)
13. pancreas 5. Fasting glucose at 3 months

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Dr. Franz Koehler Chemie GmbH

Sponsor organisation

Dr. Franz Koehler Chemie GmbH

Address

Werner-Von-Siemens-Strasse 14- 28

City

Bensheim

Postcode

64625

Country

Germany

Scientific contact point

Organisation

Dr. Franz Koehler Chemie GmbH

Contact name

Roman Petrov

Public contact point

Organisation

Dr. Franz Koehler Chemie GmbH

Contact name

Roman Petrov

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications