NCT02224820

Phase II Study, Evaluation of Safety and Efficacy of IdeS in Chronic Kidney Disease

A Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous IdeS After Administration of Ascending Doses in Chronic Kidney Disease Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Hansa Biopharma AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

IdeS is an immunoglobulin g (IgG) cleaving enzyme. It will given to patients with donor specific antibodies to reduce the antibody load and thus enable kidney transplantation. IdeS antibody reducing efficacy and its safety will be studied.

Detailed description

Study 13-HMedIdeS-02 (EudraCT no. 2013-005417-13) is a single centre, single arm, dose finding, Phase II study in sensitized CKD patients assessing safety, tolerability, pharmacokinetics (PK) and efficacy of HMED-IdeS without intent to transplantation. However, patients are not removed from the transplant waitlist during the study. Included patients has a panel reactive antibody \[PRA\] \>70% (n=7).

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
BIOLOGICAL	IdeS	Doses are administered in ascending doses

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2014-08-25
• Last updated: 2017-03-03
• Results posted: 2016-05-23

Locations

1 site across 1 country: Sweden