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NCT Number: NCT03965559

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

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?

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Key information

Conditions

Kidney Transplant Rejection Kidney Replacement Plasmapheresis

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plasmapheresis

Procedure

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 names: double filtration plasmapheresis (DFPP)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
May 29, 2019
Registry last updated
Nov 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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