Skip to content

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)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512444-29-00
Enrollment
362
Registered
2024-10-22
Start date
2019-05-07
Completion date
Unknown
Last updated
2025-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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)

Detailed description

Kidney 1. Incidence of primary poor function (creatinine at 3 month: >250  mol/l), Kidney 2. Serum creatinine, creatinine MDRD clearance, urea, and hemoglobin after 3 months, kidney 3. Requirement of dialysis until 3 month after transplantation, kidney 4. Biopsy proven rejections, 1. Absolute peak LDH within 7 days after transplantation, liver 2. Moment (day) of peak GPT and peak LDH, liver 3. Serum bilirubin, GOT, GPT, LDH, total albumin and PT at 3 months, 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, Pancreas 1. Insulin requirements on days 3 and 30 and after 3 months, pancreas 2. α-amylase, lipase, C-reactive protein (CRP) at 1 und 3 days, pancreas 3. C-peptide and HBA1c at day 30 and 3 months, pancreas 4. Pancreatic complications: graft pancreatitis, anastomotic leak, vascular complications (thrombosis, stenosis, bleeding), pancreas 5. Fasting glucose at 3 months

Interventions

Sponsors

Dr. Franz Koehler Chemie GmbH
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Kidney 1. Incidence of primary poor function (creatinine at 3 month: >250  mol/l), Kidney 2. Serum creatinine, creatinine MDRD clearance, urea, and hemoglobin after 3 months, kidney 3. Requirement of dialysis until 3 month after transplantation, kidney 4. Biopsy proven rejections, 1. Absolute peak LDH within 7 days after transplantation, liver 2. Moment (day) of peak GPT and peak LDH, liver 3. Serum bilirubin, GOT, GPT, LDH, total albumin and PT at 3 months, 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, Pancreas 1. Insulin requirements on days 3 and 30 and after 3 months, pancreas 2. α-amylase, lipase, C-reactive protein (CRP) at 1 und 3 days, pancreas 3. C-peptide and HBA1c at day 30 and 3 months, pancreas 4. Pancreatic complications: graft pancreatitis, anastomotic leak, vascular complications (thrombosis, stenosis, bleeding), pancreas 5. Fasting gluc

Countries

Austria

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026