Effects of A Standardized Treatment Approach on Kidney Transplant Recipients With Antibody-Mediated Rejection

NCT ID: NCT04367610

Last Updated: 2021-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-12-31

Brief Summary

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Antibody-mediated rejection (ABMR) is one of the leading causes of graft loss in kidney transplant recipients (KTRs). Although it is a well characterized entity, there is limited data regarding effective treatment options for preserving graft functions. Moreover, results from different studies have been contradictory. Therefore, we conducted a study using our registry data to evaluate the effects of a standardized treatment approach consisting of therapeutic plasma exchange (regular plasmapheresis, double filtration plasmapheresis or immunoadsorption), intravenous immunoglobulin and rituximab on KTRs with acute or chronic ABMR.

Detailed Description

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Conditions

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Antibody-mediated Rejection Kidney Transplant Rejection Graft Loss

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Study Group

Kidney transplant recipients with biopsy-proven acute or chronic antibody-mediated rejection who were treated using 6 sessions of therapeutic plasma exchange, 2 g/kg of intravenous immunoglobulin and 1-2 weekly doses of 375 mg/m2 rituximab.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Being a kidney transplant recipient with biopsy-proven acute or chronic antibody-mediated rejection who were treated using 6 sessions of therapeutic plasma exchange, 2 g/kg of intravenous immunoglobulin and 1-2 weekly doses of 375 mg/m2 rituximab.

Exclusion Criteria

* Not providing or withdrawing consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Safak Mirioglu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Halil Yazici, MD

Role: STUDY_CHAIR

Department of Internal Medicine, Istanbul Faculty of Medicine

Safak Mirioglu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, Istanbul Faculty of Medicine

Locations

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Istanbul University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Djamali A, Kaufman DB, Ellis TM, Zhong W, Matas A, Samaniego M. Diagnosis and management of antibody-mediated rejection: current status and novel approaches. Am J Transplant. 2014 Feb;14(2):255-71. doi: 10.1111/ajt.12589. Epub 2014 Jan 8.

Reference Type BACKGROUND
PMID: 24401076 (View on PubMed)

Other Identifiers

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2019/976

Identifier Type: -

Identifier Source: org_study_id

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