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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04367610

Enrollment

Registered

2020-04-29

Start date

2019-09-01

Completion date

2020-12-31

Last updated

2021-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibody-mediated Rejection, Graft Loss, Kidney Transplant Rejection

Keywords

antibody-mediated rejection, kidney transplantation

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Graft Loss	2-5 years	Returning to dialysis due to graft failure or death with a functioning graft.

Countries

Turkey (Türkiye)

Outcome results