Kidney Transplant RejectionNCT03965559

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

An observational study of Kidney Transplant Rejection and Plasmapheresis, run by Chiang Mai University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 15 years and older
Conditions the study is for: Kidney Transplant Rejection, Plasmapheresis, Kidney Replacement
What is being tested?: plasmapheresis
Type of treatment: Surgery or procedure
How many people: 30 participants
Where: No sites listed yet
Study dates: 1 Nov 2015to 31 Mar 2018
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

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)

Who may be able to join

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

Who cannot join

Incomplete data

About this study

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

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?

Read the 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?

Conditions: Kidney Transplant Rejection, Plasmapheresis, Kidney Replacement
Being tested: plasmapheresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

plasmapheresisProcedure or surgery
Also called double filtration plasmapheresis (DFPP)
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.]

Study groups in NCT03965559
Study group	Role	What they receive
plasmapheresis group		Kidney transplant patients who had been diagnosed or suspected of graft rejection and underwent the plasmapheresis during January 2006 to October 2015 Receives: 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 Receives: Procedure: plasmapheresis

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment response
Compare treatment response rates after complete treatment with plasmapheresis and DFPP
Measured: 1 week
Treatment response
Compare treatment response rates after complete treatment with plasmapheresis and DFPP
Measured: 1 month
Treatment response
Compare treatment response rates after complete treatment with plasmapheresis and DFPP
Measured: 3 month

Secondary outcomes (2)

Kidney loss
Comparison of kidney loss rate at 1 week, 1 month and 3 months after complete treatment during plasmapheresis with DFPP
Measured: 1 week, 1 month, and 3 month
Complications
Compare the rate of occurrence, side effects and complications during treatment plasmapheresis and DFPP
Measured: 1 week, 1 month, and 3 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 201531 Mar 2018

First posted29 May 2019
Study start1 Nov 2015
Primary completion31 Dec 2017
Study completion31 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Kidney Transplant RejectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03965559
Sponsor's protocol ID: MED-2558-03579
Status last verified: Nov 2019
First submitted: 24 May 2019
Last updated: 6 Nov 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: If it is asked for or requested for

Publications

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.
PubMed 25492162
Westall GP, Paraskeva MA, Snell GI. Antibody-mediated rejection. Curr Opin Organ Transplant. 2015 Oct;20(5):492-7. doi: 10.1097/MOT.0000000000000235.
PubMed 26262460
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.
PubMed 7027553
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.
PubMed 6342220
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.
PubMed 3915622
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.
PubMed 19917368
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.
PubMed 24655992
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.
PubMed 24655993
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.
PubMed 21486614
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.
PubMed 24472190

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Not yet recruitingPhase 2
(TNX-1500) in Kidney Transplant Recipients
Kidney Transplant, Kidney Transplant Failure and Rejection
RecruitingPhase 2
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Microvascular Inflammation
Not yet recruitingObservational study
Assessment of Perceived Stress in an Observational Study Evaluating a Biopsy-sparing Surveillance Strategy in Kidney Transplant Recipients With Blood and Urinary Biomarkers Predictive of the Absence of Rejection
Renal Transplantation; Complication, Renal Transplant

All Kidney Transplant Rejection trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy of Plasmapheresis and Double Filtration Plasmapheresis (DFPP) in Kidney Transplant Patients With Suspected Rejection: A Retrospective Study
ClinicalTrials.gov ID: NCT03965559
Acronym / sponsor ID: MED-2558-03579
Conditions: Kidney Transplant Rejection, Plasmapheresis, Kidney Replacement
Study type: Observational
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Chiang Mai UniversityUniversity, hospital or other
Study start: 1 Nov 2015 (actual)
Primary completion: 31 Dec 2017 (actual)
Study completion: 31 Mar 2018 (actual)
First posted: 29 May 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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?

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
plasmapheresis group	–	Procedure: plasmapheresisKidney transplant patients who had been diagnosed or suspected of graft rejection and underwent the plasmapheresis during January 2006 to October 2015
double filtration plasmapheresis (DFPP) group	–	Procedure: plasmapheresisKidney transplant patients who had been diagnosed or suspected of graft rejection and underwent the double filtration plasmapheresis (DFPP) during January 2006 to October 2015

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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)

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

Incomplete data

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
plasmapheresisAlso: double filtration plasmapheresis (DFPP)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.]	Procedure or surgery	double filtration plasmapheresis (DFPP) group, plasmapheresis group

Primary outcome

Treatment response
Time frame: 1 week
Compare treatment response rates after complete treatment with plasmapheresis and DFPP
Treatment response
Time frame: 1 month
Compare treatment response rates after complete treatment with plasmapheresis and DFPP
Treatment response
Time frame: 3 month
Compare treatment response rates after complete treatment with plasmapheresis and DFPP

2 secondary outcomes

Kidney loss
Time frame: 1 week, 1 month, and 3 month
Complications
Time frame: 1 week, 1 month, and 3 month

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
Background: PubMed 25492162Noppakun 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.
Background: PubMed 26262460Westall GP, Paraskeva MA, Snell GI. Antibody-mediated rejection. Curr Opin Organ Transplant. 2015 Oct;20(5):492-7. doi: 10.1097/MOT.0000000000000235.
Background: PubMed 7027553Kirubakaran 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.
Background: PubMed 6342220Allen 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.
Background: PubMed 3915622Bonomini 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.
Background: PubMed 19917368Brown 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.
Background: PubMed 24655992Larpparisuth 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.
Background: PubMed 24655993Larpparisuth 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.
Background: PubMed 21486614Gungor 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.
Background: PubMed 24472190Haas 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.
Individual participant dataSharing planned: No. If it is asked for or requested for

Related trials for Kidney Transplant Rejection

RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Not yet recruitingPhase 2
(TNX-1500) in Kidney Transplant Recipients
Kidney Transplant, Kidney Transplant Failure and Rejection
RecruitingPhase 2
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Microvascular Inflammation
Not yet recruitingObservational study
Assessment of Perceived Stress in an Observational Study Evaluating a Biopsy-sparing Surveillance Strategy in Kidney Transplant Recipients With Blood and Urinary Biomarkers Predictive of the Absence of Rejection
Renal Transplantation; Complication, Renal Transplant

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kajohnsak Noppakun, MD principal investigator

Chiang Mai University

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Transplant Rejection and Plasmapheresis, run by Chiang Mai University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment response (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03965559, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019.