NCT02351427

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 4, 2015

Status Verified

February 1, 2015

Enrollment Period

10 months

First QC Date

January 27, 2015

Last Update Submit

February 3, 2015

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

  • Serum creatinine

    Investigators measure patients' serum creatinine at day 14.

    Day 14

Secondary Outcomes (4)

  • Incidence of steroid failure

    Day 7

  • Serum creatinine

    Month 1

  • Infection

    Until 1 year after intervention

  • Recurrence of Rejection

    Until 1 year after intervention

Study Arms (2)

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

Drug: BortezomibDrug: Steroid

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

Drug: Steroid

Interventions

BortezomibDRUG

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.

Also known as: Velcade
Bortezomib
SteroidDRUG

Investigators administer steroid in both groups for conventional treatment of acute cellular rejection.

BortezomibSteroid

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

RECRUITING

Related Publications (9)

  • 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.

    PMID: 20826741BACKGROUND

  • 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.

    PMID: 22336990BACKGROUND

  • 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.

    PMID: 23195008BACKGROUND

  • 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.

    PMID: 22836132BACKGROUND

  • 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.

    PMID: 21745166BACKGROUND

  • 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.

    PMID: 22770877BACKGROUND

  • 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.

    PMID: 20535594BACKGROUND

  • 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.

    PMID: 22689676BACKGROUND

  • 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.

    PMID: 19104417RESULT

MeSH Terms

Interventions

BortezomibSteroids

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Su-Kil Park, M.D., PhD

    Division of Nephrology, Department of Internal Medicine, Asan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Su-Kil Park, M.D., PhD

CONTACT

82-2-3010-3263skpark@amc.seoul.kr

Chung Hee Baek, M.D.

CONTACT

82-2-3010-1481bch393@naver.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 27, 2015

First Posted

January 30, 2015

Study Start

February 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 4, 2015

Record last verified: 2015-02

Locations

KR(1)