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

End Stage Kidney Disease Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• End Stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic

• NCT number: NCT02475551
• Study type: Interventional
• Source: Hansa Medical AB
• Status: Completed
• Phase: Phase 2
• Start date: June 2015
• Completion date: October 2016