Clinical trial NCT02351427: Bortezomib With Steroid Pulse Therapy for Acute Cellular Rejection in Kidney Transplantation
Official title: Bortezomib With Steroid Pulse Therapy for Acute Cellular Rejection in Kidney
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Kidney Transplantation
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2015-01-30
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether bortezomib is effective in the treatment of acute cellular rejection after kidney transplantation.

Detailed description: When acute cellular rejection occurred in kidney allograft, investigators administer high dose steroid. However, there is insufficient effect in about 20-30%. Bortezomib acts not only on plasma cells, but also T cells, B cells and dendritic cells. In addition, bortezomib is relatively safe drug compared to thymoglobulin which investigators use in the cases of steroid failure. Therefore, investigators administer bortezomib with steroid in one group, and compared the group with the other group in which conventional steroid treatment is done.

Eligibility criteria: Inclusion Criteria:

* living donor kidney transplantation recipients
* patients who were performed kidney biopsies because of laboratory and clinically suspected rejection
* Biopsy proven acute cellular rejection (Banff I - IIA) with C4d negative
* Single luminex panel reactive antibody (PRA) I \& II mean fluorescent intensity (MFI) \< 3000

Exclusion Criteria:

* patients who received other major organ transplantation
* combined with urinary tract infection or obstruction
* combined with acute antibody mediated rejection
* poor compliance

Primary outcomes:
measure: Serum creatinine
timeFrame: Day 14
Secondary outcomes:
measure: Incidence of steroid failure
timeFrame: Day 7
measure: Serum creatinine
timeFrame: Month 1
measure: Infection
timeFrame: Until 1 year after intervention
measure: Recurrence of Rejection
timeFrame: Until 1 year after intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Division of Nephrology, Department of Internal Medicine, Asan Medical Center
name: Su-Kil Park, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Arnulf B, Pylypenko H, Grosicki S, Karamanesht I, Leleu X, van de Velde H, Feng H, Cakana A, Deraedt W, Moreau P. Updated survival analysis of a randomized phase III study of subcutaneous versus intravenous bortezomib in patients with relapsed multiple myeloma. Haematologica. 2012 Dec;97(12):1925-8. doi: 10.3324/haematol.2012.067793. Epub 2012 Jun 11.
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