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OpenTrials
Completed

NCT Number: NCT00908583

Desensitization in Kidney Transplantation

To determine if deletional strategies will provide effective desensitization.

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Key information

Conditions

HLA Sensitization

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Christ Hospital, Cincinnati, Ohio, United States

Loading trial locations.

About this study

A prospective iterative trial of proteasome inhibitor (PI)-based therapy for reducing HLAantibody (Ab) levels was conducted in five phases differing in bortezomib dosing density and plasmapheresis timing. Phases included 1 or 2 bortezomib cycles (1.3mg/m2,6-8 doses), one rituximab dose and plasmapheresis. HLA Abs were measured by solid phase and flow cytometry (FCM) assays. Immunodominant Ab (iAb) was defined as highest HLA Ab level. Forty-four patients received 52 desensitization courses (7 patients enrolled in multiple phases): Phase 1 (n=20), Phase 2 (n=12), Phase 3 (n=10), Phase 4 (n=5), Phase 5 (n=5).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 65
  • Voluntary written informed consent
  • Patient on deceased donor wait list with a current or peak cytotoxic or calculated panel reactive antibody (PRA) > 20%

Exclusion criteria

  • Myocardial infarction within 6 months
  • Patient received investigational drug within 14 days prior to initiation of study treatment
  • Serious medical or psychological illness
  • Diagnosed with malignancy within three years, except complete research of basal cell carcinoma or squamous cell carcinoma of skin, an insitu malignancy or low risk prostate cancer after curative therapy
  • Absolute neutrophil count (ANC) < 1000
  • Receipt of live vaccine within 4 weeks of study entry
  • Female subject that is breast feeding

Treatment and study plan

Plasmapheresis

Drug

Patients will receive plasmapheresis 1.5 x plasma volume prior to each Bortezomib dose. Plasma volume replacement will be per physician discretion.

bortezomib

Drug

Patients will receive bortezomib as described in protocol

Other names: Velcade

Rituximab

Drug

Patients will receive rituximab as described in protocol

Other names: Rituxan

methylprednisolone

Drug

Each bortezomib dose will be preceded by intravenous methylprednisolone (100mg for first two doses and 50mg for following doses).

Other names: Medrol

Primary outcomes

  1. Number of Living Donor Transplant Candidates That Are Transplanted

    Time frame: 1 year post baseline

    Number of living donor transplant candidates who convert to a negative flow T- and B-cell crossmatch via desensitization and are subsequently transplanted

Secondary outcomes

  1. Overall Safety of Bortezomib

    Time frame: Study Day 62

    Incidence of grade 3 and above non-hematologic toxicities. Incidence of grade 4 hematologic toxicities. Incidence of all grades of peripheral neuropathy. Incidence of Cytomegalovirus (CMV), Polyomavirus Allograft Nephropathy (PVN), and Posttransplant Lymphoproliferative Disorder (PTLD).

  2. Number of Patients Whose Cytotoxic Panel Reactive Antibody (PRA) is Decreased by 50%

    Time frame: 46 days

    Number of patients on the waiting list whose cytotoxic PRA is decreased by 50%.

  3. Acute Rejection Rate

    Time frame: 6 months post transplant

    Acute rejection rate at 6 months of all desensitized and transplanted patients

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • Millennium Pharmaceuticals, Inc.

Registry information

Official study title

Desensitization for Preformed Anti-HLA Antibodies in Kidney Transplantation

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
May 27, 2009
Registry last updated
Apr 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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