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The purpose of this study is to determine whether bortezomib is effective in the treatment of acute cellular rejection after kidney transplantation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bortezomib | Active Comparator | Bortezomib (subcutaneous) 1.3mg/m2 on day 1, 4 and 7 with Steroid - Methylprednisolone (intravenous) Day 1 - 7: 500 mg/500 mg/500 mg/250 mg/250 mg/125 mg/125 mg After day 7: prednisolone (oral) 30 - 60 mg, then taper the dosage |
|
| Steroid | Active Comparator | Steroid - Methylprednisolone (intravenous) Day 1 - 7: 500 mg/500 mg/500 mg/250 mg/250 mg/125 mg/125 mg After day 7: prednisolone (oral) 30 - 60 mg, then taper the dosage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug | In one group, investigators administer bortezomib and steroid to manage acute cellular rejection in kidney transplantation, and compare the results with another group in which only steroid was administered. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum creatinine | Investigators measure patients' serum creatinine at day 14. | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of steroid failure | Steroid failure is defined as serum creatinine at day 8 ≥ serum creatinine at day 0. | Day 7 |
| Serum creatinine | Investigators measure patients' serum creatinine at month 1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Su-Kil Park, M.D., PhD | Contact | 82-2-3010-3263 | skpark@amc.seoul.kr | |
| Chung Hee Baek, M.D. | Contact | 82-2-3010-1481 | bch393@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Su-Kil Park, M.D., PhD | Division of Nephrology, Department of Internal Medicine, Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | 138-736 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20826741 | Background | Lemy A, Toungouz M, Abramowicz D. Bortezomib: a new player in pre- and post-transplant desensitization? Nephrol Dial Transplant. 2010 Nov;25(11):3480-9. doi: 10.1093/ndt/gfq502. Epub 2010 Sep 8. | |
| 22336990 | Background | Walsh RC, Alloway RR, Girnita AL, Woodle ES. Proteasome inhibitor-based therapy for antibody-mediated rejection. Kidney Int. 2012 Jun;81(11):1067-74. doi: 10.1038/ki.2011.502. Epub 2012 Feb 15. |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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|
| Steroid | Drug | Investigators administer steroid in both groups for conventional treatment of acute cellular rejection. |
|
| Month 1 |
| Infection | Infection as measured by clinical, laboratory and microbiological data | Until 1 year after intervention |
| Recurrence of Rejection | Recurrence of rejection as measured by clinical and laboratory data with graft biopsy. | Until 1 year after intervention |
| 23195008 | Background | Tzvetanov I, Spaggiari M, Joseph J, Jeon H, Thielke J, Oberholzer J, Benedetti E. The use of bortezomib as a rescue treatment for acute antibody-mediated rejection: report of three cases and review of literature. Transplant Proc. 2012 Dec;44(10):2971-5. doi: 10.1016/j.transproceed.2012.02.037. |
| 22836132 | Background | Schmidt N, Alloway RR, Walsh RC, Sadaka B, Shields AR, Girnita AL, Hanseman DJ, Woodle ES. Prospective evaluation of the toxicity profile of proteasome inhibitor-based therapy in renal transplant candidates and recipients. Transplantation. 2012 Aug 27;94(4):352-61. doi: 10.1097/TP.0b013e318257acf6. |
| 21745166 | Background | Hu X, Xu J, Sun A, Shen Y, He G, Guo F. Successful T-cell acute lymphoblastic leukemia treatment with proteasome inhibitor bortezomib based on evaluation of nuclear factor-kappaB activity. Leuk Lymphoma. 2011 Dec;52(12):2393-5. doi: 10.3109/10428194.2011.593271. Epub 2011 Jul 12. No abstract available. |
| 22770877 | Background | Kim SJ, Yoon DH, Kang HJ, Kim JS, Park SK, Kim HJ, Lee J, Ryoo BY, Ko YH, Huh J, Yang WI, Kim HK, Min SK, Lee SS, Do IG, Suh C, Kim WS; Consortium for Improving Survival of Lymphoma (CISL) investigators. Bortezomib in combination with CHOP as first-line treatment for patients with stage III/IV peripheral T-cell lymphomas: a multicentre, single-arm, phase 2 trial. Eur J Cancer. 2012 Nov;48(17):3223-31. doi: 10.1016/j.ejca.2012.06.003. Epub 2012 Jul 4. |
| 20535594 | Background | Zain JM, O'Connor O. Targeted treatment and new agents in peripheral T-cell lymphoma. Int J Hematol. 2010 Jul;92(1):33-44. doi: 10.1007/s12185-010-0614-9. Epub 2010 Jun 10. |
| 22689676 | Background | 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. |
| 19104417 | Result | Everly MJ, Everly JJ, Susskind B, Brailey P, Arend LJ, Alloway RR, Roy-Chaudhury P, Govil A, Mogilishetty G, Rike AH, Cardi M, Wadih G, Tevar A, Woodle ES. Bortezomib provides effective therapy for antibody- and cell-mediated acute rejection. Transplantation. 2008 Dec 27;86(12):1754-61. doi: 10.1097/TP.0b013e318190af83. |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |