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

Kidney Transplant Rejection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03965559
• Other study ID #: MED-2558-03579
• Status: Completed
• Start date: November 1, 2015
• Est. completion date: March 31, 2018

Study information

• Verified date: November 2019
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Replacement
• Kidney Transplant Rejection
• Plasmapheresis

Intervention

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.]

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

References & Publications (10)

Allen NH, Dyer P, Geoghegan T, Harris K, Lee HA, Slapak M. Plasma exchange in acute renal allograft rejection. A controlled trial. Transplantation. 1983 May;35(5):425-8. — View Citation

Bonomini V, Vangelista A, Frascà GM, Di Felice A, Liviano D'Arcangelo G. Effects of plasmapheresis in renal transplant rejection. A controlled study. Trans Am Soc Artif Intern Organs. 1985;31:698-703. — View Citation

Brown CM, Abraham KA, O'Kelly P, Conlon PJ, Walshe JJ. Long-term experience of plasmapheresis in antibody-mediated rejection in renal transplantation. Transplant Proc. 2009 Nov;41(9):3690-2. doi: 10.1016/j.transproceed.2009.06.197. — View Citation

Gungor O, Sen S, Kircelli F, Yilmaz M, Sarsik B, Ozkahya M, Hoscoskun C, Ok E, Toz H. Plasmapheresis therapy in renal transplant patients: five-year experience. Transplant Proc. 2011 Apr;43(3):853-7. doi: 10.1016/j.transproceed.2011.03.025. — View Citation

Haas M, Sis B, Racusen LC, Solez K, Glotz D, Colvin RB, Castro MC, David DS, David-Neto E, Bagnasco SM, Cendales LC, Cornell LD, Demetris AJ, Drachenberg CB, Farver CF, Farris AB 3rd, Gibson IW, Kraus E, Liapis H, Loupy A, Nickeleit V, Randhawa P, Rodriguez ER, Rush D, Smith RN, Tan CD, Wallace WD, Mengel M; Banff meeting report writing committee. Banff 2013 meeting report: inclusion of c4d-negative antibody-mediated rejection and antibody-associated arterial lesions. Am J Transplant. 2014 Feb;14(2):272-83. doi: 10.1111/ajt.12590. Erratum in: Am J Transplant. 2015 Oct;15(10):2784. Rangel, Erika [corrected to Rangel, Erika B]. — View Citation

Kirubakaran MG, Disney AP, Norman J, Pugsley DJ, Mathew TH. A controlled trial of plasmapheresis in the treatment of renal allograft rejection. Transplantation. 1981 Aug;32(2):164-5. — View Citation

Larpparisuth N, Premasathian N, Vareesangthip K, Cheunsuchon B, Parichatikanon P, Vongwiwatana A. Clinicopathologic characteristics and outcomes of late acute antibody-mediated rejection in Thai kidney transplant recipients: a single-center experience. Transplant Proc. 2014;46(2):477-80. doi: 10.1016/j.transproceed.2014.01.003. — View Citation

Larpparisuth N, Vongwiwatana A, Vareesangthip K, Cheunsuchon B, Parichatikanon P, Premasathian N. Clinicopathologic features and treatment response of early acute antibody-mediated rejection in Thai kidney transplant recipients: a single-center experience. Transplant Proc. 2014;46(2):474-6. doi: 10.1016/j.transproceed.2013.12.022. — View Citation

Noppakun K, Ingsathit A, Pongskul C, Premasthian N, Avihingsanon Y, Lumpaopong A, Vareesangthip K, Sumethkul V; Subcommittee for Kidney Transplant Registry; Thai Transplantation Society. A 25-year experience of kidney transplantation in Thailand: report from the Thai Transplant Registry. Nephrology (Carlton). 2015 Mar;20(3):177-83. doi: 10.1111/nep.12378. — View Citation

Westall GP, Paraskeva MA, Snell GI. Antibody-mediated rejection. Curr Opin Organ Transplant. 2015 Oct;20(5):492-7. doi: 10.1097/MOT.0000000000000235. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment response	Compare treatment response rates after complete treatment with plasmapheresis and DFPP	1 week
Primary	Treatment response	Compare treatment response rates after complete treatment with plasmapheresis and DFPP	1 month
Primary	Treatment response	Compare treatment response rates after complete treatment with plasmapheresis and DFPP	3 month
Secondary	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
Secondary	Complications	Compare the rate of occurrence, side effects and complications during treatment plasmapheresis and DFPP	1 week, 1 month, and 3 month