Study to Evaluate the Safety, Tolerability, Efficacy and PK of IdeS in Kidney Transplantation

Sponsor

Hansa Biopharma AB (Industry)

Overall Status

Completed

CT.gov ID

NCT02475551

Collaborator

Uppsala University Hospital (Other), Karolinska Institutet (Other)

Enrollment

Location

Arm

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will assess the safety and efficacy of IdeS in the transplantation setting. Each patient will receive one dose of IdeS. If the crossmatch test is negative at the time of transplantation, the patient will be transplanted with a kidney from a deceased or living donor. The starting dose will be 0.25 mg/kg BW, given as a single intravenous infusion prior to surgery.

Condition or Disease	Intervention/Treatment	Phase
End Stage Kidney Disease	Drug: IdeS	Phase 2

Detailed Description

This study will assess the safety and efficacy of the IgG degrading cysteine protease IdeS in the transplantation setting. Patients with DSAs will be treated with IdeS prior to transplantation. Each patient will receive one dose of IdeS. If the crossmatch test is negative after IdeS treatment, the patient will be transplanted with a kidney from a deceased or living donor. Two to four dose groups are planned. Each group will contain 2 patients with the possibility to extend the group to up to 4 patients per group if required for safety and/or efficacy evaluation. The starting dose will be 0.25 mg/kg BW, given as a single intravenous infusion prior to surgery with the possibility to increase the dose in higher dose groups.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of Intravenous Ascending Doses of IdeS in Kidney Transplantation

Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Oct 1, 2016

Actual Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment IdeS as a single infusion	Drug: IdeS Intravenous infusion

Arm

Intervention/Treatment

Experimental: Treatment

IdeS as a single infusion

Drug: IdeS

Intravenous infusion

Outcome Measures

Primary Outcome Measures

safety [6 months]
Adverse events, clinical laboratory tests, vital signs and ECGs

Secondary Outcome Measures

Efficacy (mean fluorescent intensity (MFI) of less than 1100 as measured in an single antigen bead (SAB) assay) [24 hours]
Efficacy defined as the IdeS dosing scheme resulting in anti human leucocyte antigen (HLA) antibody levels which are acceptable for transplantation, measured as an mean fluorescent intensity (MFI) of less than 1100 as measured in an single antigen bead (SAB) assay, within 24 hours from dosing

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients diagnosed with CKD and in dialysis with preformed anti-HLA antibodies (non-DSA, DSA or both), negative T-CDC CXM and at least one antibody MFI > 3000

Exclusion Criteria:

Prior malignancy within 2 years excluding adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ and prostate cancer Gleason <6 and prostate-specific antigen (PSA) <10 ng/mL.
Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV
Clinical signs of ongoing infectious disease.
Severe other conditions requiring treatment and close monitoring, e.g. cardiac failure

New York Heart Association (NYHA) grade 3, unstable coronary disease or oxygen dependent chronic obstructive pulmonary disease (COPD)

History of any other clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at increased risk because of participation in the study, or influence the results or the patient's ability to participate in the study
Hypogammaglobulinemia defined as any values of P-total IgG less than 3 g/L
History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to IdeS (e. g streptokinase and/or staphylokinase)
Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 4 months of the first administration of investigational product in this study.
Patients consented and screened but not dosed in previous studies are not excluded

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hansa Medical AB	Lund		Sweden	22007

Sponsors and Collaborators

Hansa Biopharma AB
Uppsala University Hospital
Karolinska Institutet

Investigators

Study Director: Lena Winstedt, PhD, Hansa Biopharma AB

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hansa Biopharma AB

ClinicalTrials.gov Identifier:

NCT02475551

Other Study ID Numbers:

13-HMedIdeS-03

First Posted:

Jun 18, 2015

Last Update Posted:

Jan 8, 2018

Last Verified:

Jan 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Kidney Diseases

Kidney Failure, Chronic

Study Results

No Results Posted as of Jan 8, 2018