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NCT04367610 Clinical Trial

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

Kidney Transplant Rejection Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04367610
Other study ID # 2019/976
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date December 31, 2020

Study information
Verified date May 2021
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date December 31, 2020
Est. primary completion date August 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Turkey Istanbul University Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. Review. — View Citation

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