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
Verified date | November 2019 |
Source | Chiang Mai University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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?
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Chiang Mai University |
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04491552 -
TruGraf® Long-term Clinical Outcomes Study
|
||
Withdrawn |
NCT04560582 -
Immunosuppression Reduction in Failed Allograft Guided by cfDNA
|
||
Completed |
NCT05747274 -
SRDK0921_ Analytical Performance Study
|
||
Not yet recruiting |
NCT05482100 -
CLinical Utility of the omnigrAf® biomarkeR Panel In The Care of kidneY Transplant Recipients
|
||
Recruiting |
NCT06243289 -
Improving KIdney Transplantation With Cellular Therapy Study
|
||
Not yet recruiting |
NCT06025240 -
Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients
|
||
Completed |
NCT04367610 -
Effects of A Standardized Treatment Approach on Kidney Transplant Recipients With Antibody-Mediated Rejection
|
||
Enrolling by invitation |
NCT06126380 -
Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients
|
Phase 2 | |
Terminated |
NCT05747053 -
Personalization of Immunosuppressive Treatment for Organ Transplant Recipients
|
||
Active, not recruiting |
NCT03714113 -
Donor-specific Anti-HLA Antibodies Monitoring in Kidney Transplant Recipients
|
N/A | |
Recruiting |
NCT04091984 -
The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)
|
||
Recruiting |
NCT05335538 -
TruGraf and TRAC In Pediatrics Study
|
||
Completed |
NCT03663335 -
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients
|
Phase 2 | |
Completed |
NCT03652402 -
Precision Risk Stratification in Kidney Transplant Patients - EU-TRAIN
|
||
Recruiting |
NCT04773392 -
Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR
|
Phase 4 | |
Completed |
NCT03873623 -
The TOGETHER Project - Kidney
|
||
Terminated |
NCT02974686 -
Conversion From MPA to Zortress (Everolimus) for GI Toxicity Post-renal Transplantation
|
Phase 4 | |
Terminated |
NCT04156204 -
Immunosuppressant Medication Dosed Daily After Kidney Transplant
|
Early Phase 1 | |
Completed |
NCT04601155 -
Transition of Renal Patients Using AlloSure Into Community Kidney Care
|
||
Completed |
NCT03874299 -
The TOGETHER Project - Kidney RNA-seq Validation
|