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

Phase 1

Conditions: Removal of anti-HLA antibodies in patients planned to undergo kidney transplantation
Therapeutic area: Not possible to specify

Registration Number: EUCTR2014-000712-34-SE

Lead Sponsor: Hansa Medical AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>2.Cytotoxic sera screen<br>3.FACS crossmatch test<br>4.The pharmacokinetic <br>5.Pharmacodynamic <br>6.Immunogenicity <br>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 Outcome Measures

Name	Time	Method
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. <br>2.Cytotoxic sera screen<br>3.FACS crossmatch test<br>4.The pharmacokinetic <br>5.Pharmacodynamic <br>6.Immunogenicity <br>7. Kidney function<br>8. Reduction i PRA levels;Timepoint(s) of evaluation of this end point: 24 h