Chronic Kidney Disease with donor specific antibodies (ASA)
Conditions
Interventions
Product Name: HMED-IdeS
Product Code: HMED-IdeS
Pharmaceutical Form: Solution for infusion
Sponsors
Hansa Medical AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female age 18-70 years at the time of screening Patients on the kidney transplant waitlist who have previously undergone desensitization unsuccessfully or in whom effective desensitization will be highly unlikely. Patients with a live or deceased donor with a positive crossmatch test. Patient must be able to understand and sign the informed consent 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 14 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: Previous treatment with IdeS Previous high dose IVIg treatment (2 g/kg BW) within 28 days prior to IdeS treatment Lactating or pregnant females, women of child-bearing age who are not willing or able to practice FDA-approved forms of contraception HIV-positive patients Patients with HBV infection or HCV infection Patients with active tuberculosis A significantly abnormal general serum screening lab result according to the investigator’s judgement. Severe other conditions requiring treatment and close monitoring, e.g. cardiac failure, unstable coronary disease or oxygen dependent COPD Patients with active CMV or EBV infection Patients with a history of major thrombotic events, patients with active peripheral vascular disease or patients with proven hypercoagulable conditions Allergy/sensivity to IdeS infusions Patients who have a live donor and test positive for ImmunoCAP anti-IdeS IgE
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To asses the IdeS efficacy in creating a negative crossmatch test;Secondary Objective: To determine DSA levels at multiple times To determine time to creating a negative CDC crossmatch test To determine time to creating a negative FACS crossmatch test To evaluate safety parameters To monitor kidney function after IdeS treatment To establish the pharmacokinetic (PK) profile of IdeS To establish the pharmacodynamic (PD) profile of IdeS To establish the immunogenicity profile (ADA) of IdeS ;Primary end point(s): Efficacy defined as IdeS ability to create a negative crossmatch test within 24 hours after IdeS dosing;Timepoint(s) of evaluation of this end point: Within 24 hours after IdeS dosing | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): DSA levels at pre-dose and 2, 6, 24 and 48 hours and days 7, 14, 21, 28, 64, 90, 120 and 180 post IdeS treatment Time to creating a negative CDC crossmatch test Time to creating a negative FACS crossmatch test Safety parameters (adverse events, clinical laboratory tests, vital signs and ECGs) Kidney function after IdeS treatment assessed by, filtration (eGFR), creatinine and proteinuria up to 180 days post treatment Pharmacokinetic (PK) profile of IdeS up to day 14 Pharmacodynamic (PD) profile of IdeS (cleavage and recovery of IgG) up to day 180 post IdeS Immunogenicity profile of IdeS by measuring anti-drug antibodies (ADA) ;Timepoint(s) of evaluation of this end point: DSA levels at pre-dose and 2, 6, 24 and 48 hours and days 7, 14, 21, 28, 64, 90, 120 and 180 post IdeS treatment Safety parameters at 2, 6, 24 and 48 hours and days 3, 7, 9, 14, 21, 28, 64, 90, 120 and 180 post IdeS treatment Kidney function at 24 and 48 hours and days 3, 7, 9, 14, 21, 28, 64, 90, 120 and 180 post IdeS treatment | — |
Countries
France, Sweden, United States
Contacts
Public ContactClinical Trials Information
Hansa Medical AB
Outcome results
None listed