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

NCT03965559 | Completed

• 1 other identifier: MED-2558-03579
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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?

Conditions

Kidney Transplant Rejection; Plasmapheresis; Kidney Replacement

Outcome Measures

Primary Outcomes (3)

• Treatment response

  Compare treatment response rates after complete treatment with plasmapheresis and DFPP

  1 week

• Treatment response

  Compare treatment response rates after complete treatment with plasmapheresis and DFPP

  1 month

• Treatment response

  Compare treatment response rates after complete treatment with plasmapheresis and DFPP

  3 month

Secondary Outcomes (2)

• Kidney loss

  1 week, 1 month, and 3 month

• Complications

  1 week, 1 month, and 3 month

Study Arms (2)

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

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

Interventions

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

Also known as: double filtration plasmapheresis (DFPP)

double filtration plasmapheresis (DFPP) group; plasmapheresis group

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• Patients older than 15 years
• Kidney transplant patients who have been diagnosed or suspected of having graft rejection from antibodies

You may not qualify if:

• Incomplete data

Sponsors & Collaborators

• Chiang Mai University: lead

Related Publications (10)

• 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.

  PMID: 25492162 BACKGROUND

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

  PMID: 26262460 BACKGROUND

• 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. doi: 10.1097/00007890-198108000-00019. No abstract available.

  PMID: 7027553 BACKGROUND

• 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. doi: 10.1097/00007890-198305000-00006.

  PMID: 6342220 BACKGROUND

• Bonomini V, Vangelista A, Frasca 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. No abstract available.

  PMID: 3915622 BACKGROUND

• 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.

  PMID: 19917368 BACKGROUND

• 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.

  PMID: 24655992 BACKGROUND

• 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.

  PMID: 24655993 BACKGROUND

• 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.

  PMID: 21486614 BACKGROUND

• 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.

  PMID: 24472190 BACKGROUND

MeSH Terms

Interventions

Plasmapheresis

Intervention Hierarchy (Ancestors)

Blood Component Removal; Therapeutics; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Kajohnsak Noppakun, MD

  Chiang Mai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 29, 2019
• Study Start: November 1, 2015
• Primary Completion: December 31, 2017
• Study Completion: March 31, 2018
• Last Updated: November 6, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share