The Efficacy of Plasmapheresis and Double Filtration Plasmapheresis (DFPP) in Kidney Transplant

Study Overview
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Brief Summary
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At present, the number of end-stage kidney disease patients is increasing. Kidney transplant surgery is one of the treatments that give patients a better survival rate than hemodialysis or abdominal dialysis. In Thailand, there were 5,729 kidney transplant patients or 88.9 cases per million population in 2012. Among this number, 465 were new surgical patients or 7.2 cases per million population. From the year 2007-2012, the survival rate of the kidney donor from living donor kidney transplant (LDKT) was 98.5 percent and 93.3 percent at 1 and 5 years, respectively. The most common cause of graft loss was chronic rejection by 33% of all graft loss. However, 16.1 percent were unknown reasons for graft loss. The research question is In patients with kidney transplantation who suspected graft rejection Is it true that doing plasmapheresis or DFPP is no different. The researcher therefore conducted a comparative study. Is plasmapheresis or DFPP effective or different side effects?

Detailed Description
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Rejection condition can be divided into 2 groups, namely cellular rejection and antibody-mediated rejection (AbMR) by acute AbMR treatment according to the guidelines for care for kidney transplant patients in Thailand, 2014. The introduction of a single filter plasma (plasmapheresis) or 2 filters (DFPP) in combination with IVIG (intravenous immunoglobulin), which may or may not be given methylprednisolone. If the patients did not response to the treatment, Rituximab or Bortezomib was considered. Only one previous study showed that among 29 graft rejected patients treated with plasmapheresis, 37.9% had subsequently graft loss and the rest of them had significantly decreasing creatinine level at 1 month follow-up. Another group of 10 graft rejected patients treated with DFPP, 40% had subsequently graft loss. Six patients had decreasing creatinine level at 1 month follow-up. Both groups do not have complications or side effects from plasmapheresis or DFPP. The researcher therefore conducted a comparative study. Is plasmapheresis or DFPP effective or different side effects in treating post-kidney transplant patients who suspected of graft rejection?

Official Title
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The Efficacy of Plasmapheresis and Double Filtration Plasmapheresis (DFPP) in Kidney Transplant Patients With Suspected Rejection: A Retrospective Study

Conditions
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Kidney Transplant Rejection, Plasmapheresis, Kidney Replacement

Intervention / Treatment
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* Procedure: plasmapheresis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 15 years Kidney transplant patients who have been diagnosed or suspected of having graft rejection from antibodies Exclusion Criteria: Incomplete data

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| plasmapheresis group<br>Kidney transplant patients who had been diagnosed or suspected of graft rejection and underwent the plasmapheresis during January 2006 to October 2015 | Procedure: plasmapheresis<br>* Plasmapheresis is the removal, treatment, and return or exchange of blood plasma or components thereof from and to the blood circulation. It is thus an extracorporeal therapy (a medical procedure performed outside the body).[Wikipedia] DFPP is a selectively removal of the immunoglobulin fraction from the serum and, as a result, to minimize the volume of substitution fluid required. [Tanabe K. Double-filtration plasmapheresis. Transplantation. 2007 Dec 27;84(12 Suppl):S30-2.]<br>* Other names: double filtration plasmapheresis (DFPP);|
| double filtration plasmapheresis (DFPP) group<br>Kidney transplant patients who had been diagnosed or suspected of graft rejection and underwent the double filtration plasmapheresis (DFPP) during January 2006 to October 2015 | Procedure: plasmapheresis<br>* Plasmapheresis is the removal, treatment, and return or exchange of blood plasma or components thereof from and to the blood circulation. It is thus an extracorporeal therapy (a medical procedure performed outside the body).[Wikipedia] DFPP is a selectively removal of the immunoglobulin fraction from the serum and, as a result, to minimize the volume of substitution fluid required. [Tanabe K. Double-filtration plasmapheresis. Transplantation. 2007 Dec 27;84(12 Suppl):S30-2.]<br>* Other names: double filtration plasmapheresis (DFPP);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment response | Compare treatment response rates after complete treatment with plasmapheresis and DFPP | 1 week | 
| Treatment response | Compare treatment response rates after complete treatment with plasmapheresis and DFPP | 1 month | 
| Treatment response | Compare treatment response rates after complete treatment with plasmapheresis and DFPP | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kidney loss | Comparison of kidney loss rate at 1 week, 1 month and 3 months after complete treatment during plasmapheresis with DFPP | 1 week, 1 month, and 3 month | 
| Complications | Compare the rate of occurrence, side effects and complications during treatment plasmapheresis and DFPP | 1 week, 1 month, and 3 month |