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

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ClinicalTrials.gov Identifier: NCT03965559
Recruitment Status : Completed
First Posted : May 29, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Kajohnsak Noppakun, 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?


Condition or disease Intervention/treatment
Kidney Transplant Rejection Plasmapheresis Kidney Replacement Procedure: plasmapheresis

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?

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Efficacy of Plasmapheresis and Double Filtration Plasmapheresis (DFPP) in Kidney Transplant Patients With Suspected Rejection: A Retrospective Study
Actual Study Start Date : November 1, 2015
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
plasmapheresis group
Kidney transplant patients who had been diagnosed or suspected of graft rejection and underwent the plasmapheresis during January 2006 to October 2015
Procedure: plasmapheresis

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.]

Other Name: double filtration plasmapheresis (DFPP)

double filtration plasmapheresis (DFPP) group
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

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.]

Other Name: double filtration plasmapheresis (DFPP)




Primary Outcome Measures :
  1. Treatment response [ Time Frame: 1 week ]
    Compare treatment response rates after complete treatment with plasmapheresis and DFPP

  2. Treatment response [ Time Frame: 1 month ]
    Compare treatment response rates after complete treatment with plasmapheresis and DFPP

  3. Treatment response [ Time Frame: 3 month ]
    Compare treatment response rates after complete treatment with plasmapheresis and DFPP


Secondary Outcome Measures :
  1. Kidney loss [ Time Frame: 1 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

  2. Complications [ Time Frame: 1 week, 1 month, and 3 month ]
    Compare the rate of occurrence, side effects and complications during treatment plasmapheresis and DFPP



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The research team will search for medical records, outpatients and / or inpatients of the index cases of kidney transplant patients who had been diagnosed or suspected of graft rejection and was treated with either plasmapheresis or DFPP during January 2006 to October 2015

To record the following details

  • Demographic data of patients (Demographic Data)
  • Clinical clinical presentation
  • Existing diseases and medications
  • Kidney transplantation information Landscape used Levels of autoimmune conditions during the 6 months before renal salivation
  • Preliminary laboratory results Including sugar levels Blood fat level Before treatment and after treatment at 1 week, 1 month and 3 months
  • Renal biopsy results before and after treatment (if any)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965559


Sponsors and Collaborators
Chiang Mai University
Investigators
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Principal Investigator: Kajohnsak Noppakun, MD Chiang Mai University
Publications:

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Responsible Party: Kajohnsak Noppakun, Assistant Professor, Chiang Mai University
ClinicalTrials.gov Identifier: NCT03965559    
Other Study ID Numbers: MED-2558-03579
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: If it is asked for or requested for

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No