- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04367610
Effects of A Standardized Treatment Approach on Kidney Transplant Recipients With Antibody-Mediated Rejection
May 16, 2021 updated by: Safak Mirioglu, Istanbul University
Effects of A Standardized Treatment Approach Comprising Plasma Exchange, Intravenous Immunoglobulin and Rituximab on Kidney Transplant Recipients With Acute or Chronic 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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
75
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey
- Istanbul University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Graft Loss
Time Frame: 2-5 years
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Returning to dialysis due to graft failure or death with a functioning graft.
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2-5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2019
Primary Completion (Actual)
August 31, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
April 27, 2020
First Submitted That Met QC Criteria
April 27, 2020
First Posted (Actual)
April 29, 2020
Study Record Updates
Last Update Posted (Actual)
May 18, 2021
Last Update Submitted That Met QC Criteria
May 16, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2019/976
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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