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

Completed

• Conditions: Graft Loss; Antibody-mediated Rejection; Kidney Transplant Rejection

• Registration Number: NCT04367610
• Lead Sponsor: Istanbul University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-29
• Primary Completion: 2020-08-31
• Study Completion: 2020-12-31
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-16
• Last Update Posted: 2021-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Graft Loss	2-5 years	Returning to dialysis due to graft failure or death with a functioning graft.

Trial Locations

Locations (1)

Istanbul University; 🇹🇷 Istanbul, Turkey