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

Sponsor
Asan Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02351427
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
10
Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Bortezomib With Steroid Pulse Therapy for Acute Cellular Rejection in Kidney
Study Start Date :
Feb 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2015
Anticipated Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Bortezomib

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: Bortezomib
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.
Other Names:
  • Velcade

    • Drug: Steroid
    Investigators administer steroid in both groups for conventional treatment of acute cellular rejection.
    Active Comparator: Steroid

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

    Outcome Measures

    Primary Outcome Measures

    1. Serum creatinine [Day 14]

      Investigators measure patients' serum creatinine at day 14.

    Secondary Outcome Measures

    1. Incidence of steroid failure [Day 7]

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

    2. Serum creatinine [Month 1]

      Investigators measure patients' serum creatinine at month 1.

    3. Infection [Until 1 year after intervention]

      Infection as measured by clinical, laboratory and microbiological data

    4. Recurrence of Rejection [Until 1 year after intervention]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asan Medical Center Seoul Korea, Republic of 138-736

    Sponsors and Collaborators

    • Asan Medical Center

    Investigators

    • Principal Investigator: Su-Kil Park, M.D., PhD, Division of Nephrology, Department of Internal Medicine, Asan Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Su-Kil Park, Professor, Asan Medical Center
    ClinicalTrials.gov Identifier:
    NCT02351427
    Other Study ID Numbers:
    • 2014-1223
    First Posted:
    Jan 30, 2015
    Last Update Posted:
    Feb 4, 2015
    Last Verified:
    Feb 1, 2015
    Additional relevant MeSH terms:
    Bortezomib

    Study Results

    No Results Posted as of Feb 4, 2015