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

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.

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Key information

Conditions

Antibody-mediated Rejection Graft Loss Kidney Transplant Rejection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Graft Loss

Time frame: 2-5 years

Returning to dialysis due to graft failure or death with a functioning graft.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Effects of A Standardized Treatment Approach Comprising Plasma Exchange, Intravenous Immunoglobulin and Rituximab on Kidney Transplant Recipients With Acute or Chronic Antibody-Mediated Rejection

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Apr 29, 2020
Registry last updated: May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed