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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03965559
Enrollment
30
Registered
2019-05-29
Start date
2015-11-01
Completion date
2018-03-31
Last updated
2019-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Replacement, Kidney Transplant Rejection, Plasmapheresis

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?

Interventions

PROCEDUREplasmapheresis

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. \[Tanabe K. Double-filtration plasmapheresis. Transplantation. 2007 Dec 27;84(12 Suppl):S30-2.\]

Sponsors

Chiang Mai University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Treatment response1 weekCompare treatment response rates after complete treatment with plasmapheresis and DFPP

Secondary

MeasureTime frameDescription
Kidney loss1 week, 1 month, and 3 monthComparison 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 monthCompare the rate of occurrence, side effects and complications during treatment plasmapheresis and DFPP

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026