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Kidney TransplantationPhase 3NCT02351427

Bortezomib With Steroid Pulse Therapy for Acute Cellular Rejection in Kidney Transplantation

A Phase 3 study testing Bortezomib and Steroid in people with Kidney Transplantation, run by Asan Medical Center at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 19 years and older
Conditions the study is for
Kidney Transplantation
What is being tested?
Bortezomib and Steroid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSouth Korea
Study dates
Feb 2015to Dec 2015
Phase
Phase 3
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

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

South Korea1 site, 1 recruiting

  • Asan Medical Center

    Seoul, 138-736

    Su-Kil Park, M.D., PhD, 82-2-3010-3263, skpark@amc.seoul.kr

    Chung Hee Baek, M.D., 82-2-3010-1481, bch393@naver.com

    Recruiting

Other trials in South Korea

About this study

Official title: Bortezomib With Steroid Pulse Therapy for Acute Cellular Rejection in Kidney

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

Read the 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.

Being tested
Bortezomib, Steroid

What participants receive

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

  • BortezomibDrug

    Also called Velcade

    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.

  • SteroidDrug

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

Study groups in NCT02351427
Study groupRoleWhat they receive
BortezomibActive comparatorBortezomib (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
Receives: Drug: Bortezomib; Drug: Steroid
SteroidActive comparatorSteroid - 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
Receives: Drug: Steroid

What is being measured

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

  1. Serum creatinine

    Investigators measure patients' serum creatinine at day 14.

    Measured: Day 14

Secondary outcomes (4)

  1. Incidence of steroid failure

    Steroid failure is defined as serum creatinine at day 8 ≥ serum creatinine at day 0.

    Measured: Day 7

  2. Serum creatinine

    Investigators measure patients' serum creatinine at month 1.

    Measured: Month 1

  3. Infection

    Infection as measured by clinical, laboratory and microbiological data

    Measured: Until 1 year after intervention

  4. Recurrence of Rejection

    Recurrence of rejection as measured by clinical and laboratory data with graft biopsy.

    Measured: Until 1 year after intervention

Timeline

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

  1. First posted30 Jan 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionDec 2015 (estimated)
  4. Study completionDec 2015 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02351427
Sponsor's protocol ID
2014-1223
Status last verified
Feb 2015
First submitted
27 Jan 2015
Last updated
4 Feb 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20826741

  • 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.

    PubMed 22336990

  • 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.

    PubMed 23195008

  • 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.

    PubMed 22836132

  • 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.

    PubMed 21745166

  • 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.

    PubMed 22770877

  • 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.

    PubMed 20535594

  • 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.

    PubMed 22689676

  • 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.

    PubMed 19104417

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bortezomib and Steroid in people with Kidney Transplantation, run by Asan Medical Center at 1 site in South Korea.

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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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

Contact Su-Kil Park, M.D., PhD (82-2-3010-3263, skpark@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum creatinine (time frame: Day 14). 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 NCT02351427, which also lists 9 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 4 Feb 2015.

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