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Clinical Trials/EUCTR2020-004777-49-AT
EUCTR2020-004777-49-AT
Active, not recruiting
Phase 1

A prospective, observational long-term follow-up trial of kidney transplant patients treated with imlifidase or plasma exchange after an active/chronic active Antibody-Mediated Rejection episode

Hansa Biopharma0 sites30 target enrollmentDecember 17, 2020
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ConditionsAntibody-mediated rejection in kidney transplant patientsMedDRA version: 20.0Level: PTClassification code 10023439Term: Kidney transplant rejectionSystem Organ Class: 10021428 - Immune system disordersTherapeutic area: Body processes [G] - Immune system processes [G12]
DrugsIdefirix

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Antibody-mediated rejection in kidney transplant patients
Sponsor
Hansa Biopharma
Enrollment
30
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 17, 2020
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Hansa Biopharma

Eligibility Criteria

Inclusion Criteria

  • •Signed Informed Consent obtained before any trial\-related procedures
  • •Willingness and ability to comply with the protocol
  • •Previous treatment with imlifidase or plasma exchange in trial 16\-HMedIdeS\-12
  • •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 25
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 5

Exclusion Criteria

  • •Inability by the judgement of the investigator to participate in the trial for any other reason

Outcomes

Primary Outcomes

Not specified

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