A STUDY TO EVALUATE THE SAFETY AND EFFICACY OF IDES IN KIDNEY TRANSPLANTATION

A PHASE II STUDY TO EVALUATE THE SAFETY, TOLERABILITY, EFFICACY AND PHARMACOKINETICS OF INTRAVENOUS ASCENDING DOSES OF IDES IN KIDNEY TRANSPLANTATION

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000712-34-SE

Enrollment

Unknown

Registered

2014-06-02

Start date

2015-02-18

Completion date

Unknown

Last updated

2017-01-23

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

Conditions

Removal of anti-HLA antibodies in patients planned to undergo kidney transplantation

Interventions

Product Name: HMEDIdeS Product Code: HMEDIdeS Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18 years or above 2. Patients diagnosed with CKD and in dialysis with one of the following conditions will be included: • Preformed anti-HLA antibodies (non-DSA, DSA or both), negative T-CDC CXM and at least one antibody MFI > 3000 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12

Exclusion criteria

Exclusion criteria: Clinical signs of ongoing infectious disease. This includes P-CRP >10. Severe other conditions requiring treatment and close monitoring, e.g. cardiac failure > NYHA (New York Heart Association) grade 3, unstable coronary disease or oxygen dependent COPD

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the safety and tolerability of IdeS min renal transplantation;Secondary Objective: 1. To find an IdeS dose which in the majority of the patients results in HLA antibody levels acceptable for transplantation. 2. Cytotoxic sera screen 3. FACS crossmatch test 4. The pharmacokinetic 5. Pharmacodynamic 6. Immunogenicity 7. Kidney function;Primary end point(s): Safety parameters (Adverse events, clinical laboratory tests, vital signs and ECGs);Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Main Objective: To study the safety and tolerability of IdeS min renal transplantation;Secondary Objective: 1. To find an IdeS dose which in the majority of the patients results in HLA antibody levels acceptable for transplantation. 2. Cytotoxic sera screen 3. FACS crossmatch test 4. The pharmacokinetic 5. Pharmacodynamic 6. Immunogenicity 7. Kidney function;Primary end point(s): Safety parameters (Adverse events, clinical laboratory tests, vital signs and ECGs);Timepoint(s) of evaluation of this end point: 6 months

—

Secondary

Measure	Time frame
Secondary end point(s): 1. To find an IdeS dose which in the majority of the patients results in HLA antibody levels acceptable for transplantation. 2. Cytotoxic sera screen 3. FACS crossmatch test 4. The pharmacokinetic 5. Pharmacodynamic 6. Immunogenicity 7. Kidney function 8. Reduction i PRA levels;Timepoint(s) of evaluation of this end point: 24 h	—

Countries

Sweden

Contacts

Public ContactHansa Medical AB

Hansa Medical AB

+46768581506

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026