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Trial record 1 of 14 for:    mark stegall transplant
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Impact of Proteasome Inhibition on Anti-Donor HLA Antibody Production After Kidney Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01349595
Recruitment Status : Terminated (Study halted due to lack of funding)
First Posted : May 6, 2011
Results First Posted : September 9, 2015
Last Update Posted : October 28, 2015
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Mark Stegall, Mayo Clinic

Brief Summary:
The purpose of this study is to see if treating patients who have high levels of donor specific alloantibodies post-transplant with bortezomib might prevent the development of transplant glomerulopathy and preserve allograft function.

Condition or disease Intervention/treatment Phase
Disorder of Transplanted Kidney Drug: Bortezomib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Proteasome Inhibition on Anti-Donor HLA Antibody Production After Kidney Transplantation
Study Start Date : December 2011
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Bortezomib

Arm Intervention/treatment
Experimental: Bortezomib
Bortezomib is a type of targeted chemotherapy
Drug: Bortezomib
Patients randomized to bortezomib treatment will receive 2, 4-dose cycles of drug followed by a 2 month "hiatus". At the end of this time, subjects will be re-evaluated for the appropriateness of receiving a 3rd and 4th cycle of bortezomib. Bortezomib will be given subcutaneously (under the skin). If unable to give subcutaneously, bortezomib will be given as a single IV (injection into vein) over a time of 3 to 5 seconds. Patients will receive up to 4, four-dose cycles of 1.3 mg/m(2) (based on body surface area).
Other Name: Velcade

No Intervention: Standard Post-transplant Treatment
Mayo Clinic standard post kidney transplant follow-up.

Primary Outcome Measures :
  1. The Incidence of a Combined Endpoint of Death-censored Graft Loss or Greater Than 50% Reduction in Estimated Glomerular Filtration (eGFR) in Study Subjects. [ Time Frame: 60 months after enrollment in the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female subject is either postmenopausal for at least 1 year before the screening visit, surgically sterilized, or if they are of childbearing potential agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of bortezomib, or agree to completely abstain from heterosexual intercourse.
  • Male subjects, even if surgically sterilized (i.e. status postvasectomy), must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug or completely abstain from heterosexual intercourse.
  • Kidney transplant recipients (living and deceased donors) who received a transplant in the last 3 years and have high Donor Specific Antibody (DSA) levels (defined as Mean Fluorescent Intensity levels >2000 by solid phase and single antigen bead LABscreen assays).

Exclusion Criteria:

  • Patients who are recipients of ABO (blood type) incompatible kidney transplants.
  • Patient with an Glomerular Filtration Rate (eGFR) ≤30 m/min at time of study entry.
  • Patient with biopsy proven transplant glomerulopathy (Banff 2007 - cg score ≥2) within 2 months prior to randomization.
  • Patients with biopsy-proven acute rejection at the time of randomization defined as Acute Cellular Rejection Patients with documented biopsy proven recurrence of disease or de novo glomerular disease post-transplant prior to enrollment.
  • Patient has a platelet count of <30 x 10(9)/L within 14 days before enrollment.
  • Patient has an absolute neutrophil count of <1.0 x 10(9)/L within 14 days before enrollment.
  • Patient has a history of post-transplant neutropenia on mycophenolate based immunosuppressive therapy.
  • Evidence of severe liver disease with abnormal liver profile (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >3 times upper limit of normal [ULN]) at screening.
  • Patient has >1.5 x ULN Total Bilirubin.
  • Patient had any history of myocardial infarction in the past 3 years prior to enrollment or has New York Heart Association (NYHA) Class II to IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant.
  • Patient has hypersensitivity to bortezomib, boron, or mannitol.
  • Female subject is pregnant or lactating.
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
  • Cytomegalovirus (CMV) sero-negative recipients who received a transplant from a CMV-sero-positive donor.(CMV- recipients of CMV- donor kidneys are acceptable)
  • Epstein Barr Virus (EBV) sero-negative recipients.
  • History of CMV + or EBV + viremia since transplantation.
  • History of SPELL OUT HCV positivity (by PCR).
  • History of Post-transplant lymphoproliferative disease.
  • History of polyoma virus nephropathy or BK virus viremia (peripheral blood viral load of 5000 to 5,000,000 copies/mL).
  • Patients who are HIV-positive or HBsAg-positive.
  • Recipients of a kidney from a donor who tests positive for HIV, HBsAg or anti-HCV.
  • Patients with current or recent severe systemic (pathogen detected in blood or Cerebrospinal fluid) infections within the 4 weeks prior to randomization.
  • Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
  • Patient is currently receiving everolimus, sirolimus, or azathioprine as one of the immunosuppressive agents and intends to remain on this regimen.
  • Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial.
  • Inability to perform followup or to undergo protocol biopsy.
  • Active diabetic neuropathy at the time of treatment initiation.
  • Patient has ≥Grade 2 peripheral neuropathy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01349595

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mark Stegall
Millennium Pharmaceuticals, Inc.
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Principal Investigator: Mark Stegall, MD Mayo Clinic
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Responsible Party: Mark Stegall, Sponsor-Investigator, Mayo Clinic Identifier: NCT01349595    
Other Study ID Numbers: 10-001487
First Posted: May 6, 2011    Key Record Dates
Results First Posted: September 9, 2015
Last Update Posted: October 28, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Antineoplastic Agents