MedTrace Logo

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

NCT02475551 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-01-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

IdeS

Intravenous infusion

Sponsors & Collaborators

  • Uppsala University Hospital

    collaborator OTHER

  • Karolinska Institutet

    collaborator OTHER

  • Hansa Biopharma AB

    lead INDUSTRY

Principal Investigators

  • Lena Winstedt, PhD · Hansa Biopharma AB

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02475551 on ClinicalTrials.gov