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

Completed
Conditions
Plasmapheresis
Kidney Replacement
Kidney Transplant Rejection
Interventions
Procedure: plasmapheresis
Registration Number
NCT03965559
Lead Sponsor
Chiang Mai University
Brief Summary

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

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?

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
plasmapheresis groupplasmapheresisKidney transplant patients who had been diagnosed or suspected of graft rejection and underwent the plasmapheresis during January 2006 to October 2015
double filtration plasmapheresis (DFPP) groupplasmapheresisKidney transplant patients who had been diagnosed or suspected of graft rejection and underwent the double filtration plasmapheresis (DFPP) during January 2006 to October 2015
Primary Outcome Measures
NameTimeMethod
Treatment response3 month

Compare treatment response rates after complete treatment with plasmapheresis and DFPP

Secondary Outcome Measures
NameTimeMethod
Kidney loss1 week, 1 month, and 3 month

Comparison of kidney loss rate at 1 week, 1 month and 3 months after complete treatment during plasmapheresis with DFPP

Complications1 week, 1 month, and 3 month

Compare the rate of occurrence, side effects and complications during treatment plasmapheresis and DFPP

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