Open, Randomized, Active Comparator-controlled, Multi-Center Study to Evaluate Safety and Efficacy of IBsolvMIR® in Islet Transplantation

Open, Randomized, Active Comparator-controlled, Multi-Center Study to Evaluate Safety and Efficacy of IBsolvMIR® in Islet Transplantation - IBsolvMIR in islet transplantation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54194

Enrollment

Registered

2022-03-07

Start date

2024-01-26

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

Type 1 diabetes youth onset diabetes

Interventions

IBsolvmir (low molecular weight dextran sulphate) instead of heparin during islet transplantation

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Complicated type1 diabetes, either with a previous kidney transplantation or with severe hypoglycemia, waitlisted for allogeneic islet transplantation

Exclusion criteria

Exclusion criteria: - Patients ineligible for islet transplant - Patients with coagulation disorders - Patients with prior organ transplants other than a kidney graft and/or islets. A previous pancreas transplant can be accepted if it failed within the first week due to thrombosis and the graft was removed

Design outcomes

Primary

Measure	Time frame
Presence of Adverse Events (AEs) [ Time Frame: Up to 44 days. ] Presence, seriousness and relatedness of AEs to the study drugs will be recorded. AEs will be recorded day 0 - day 14. Serious Adverse Events (SAEs) will be recorded day 0 - day 44	—

Secondary

Measure	Time frame
Change in levels of thrombin-antithrombin (TAT) [ Time Frame: Within 1 day. ] Change in levels of TAT (ng/mL) between treatment groups at baseline and 7 time-points within the first 24 hours after islet transplantation. Change in levels of C-peptide [ Time Frame: Within 1 day. ] Change in levels of C-peptide (ng/mL) between treatment groups at baseline and 7 time-points within the first 24 hours after islet transplantation. Change in levels of Complement Activation Fragment C3a [ Time Frame: Within 1 day. ] Change in levels of C3a (pg/mL) between treatment groups at baseline and 7 time-points within the first 24 hours after islet transplantation. Change in levels of Hepatocyte Growth Factor (HGF) [ Time Frame: Within 1 day ] Change in levels of HGF (ng/ml) between treatment groups at baseline and 7 time-points within the first 24 hours after islet transplantation. Change in C-peptide / (glucose x creatinine) ratio (CPGCR) [ Time Frame: Within 14 days. ] Change in CPGCR at day 14 compared to baseline. CPGCR is calculated by: C-peptide (ng/mL) / ( glucose (mg/dL) x creatinine ratio (mg/dL) )	—

Measure

Time frame

Change in levels of thrombin-antithrombin (TAT) [ Time Frame: Within 1 day. ] Change in levels of TAT (ng/mL) between treatment groups at baseline and 7 time-points within the first 24 hours after islet transplantation. Change in levels of C-peptide [ Time Frame: Within 1 day. ] Change in levels of C-peptide (ng/mL) between treatment groups at baseline and 7 time-points within the first 24 hours after islet transplantation. Change in levels of Complement Activation Fragment C3a [ Time Frame: Within 1 day. ] Change in levels of C3a (pg/mL) between treatment groups at baseline and 7 time-points within the first 24 hours after islet transplantation. Change in levels of Hepatocyte Growth Factor (HGF) [ Time Frame: Within 1 day ] Change in levels of HGF (ng/ml) between treatment groups at baseline and 7 time-points within the first 24 hours after islet transplantation. Change in C-peptide / (glucose x creatinine) ratio (CPGCR) [ Time Frame: Within 14 days. ] Change in CPGCR at day 14 compared to baseline. CPGCR is calculated by: C-peptide (ng/mL) / ( glucose (mg/dL) x creatinine ratio (mg/dL) )

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)