Induction Therapy Study in Live Donor Kidney Transplant Recipients With a Positive Crossmatch
NCT ID: NCT00275509
Last Updated: 2018-01-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
56 participants
INTERVENTIONAL
2007-01-31
2010-06-30
Brief Summary
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Detailed Description
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In order to address this problem, we developed an antibody depletion protocol that permits transplantation in patients who have a positive crossmatch with their live donor. The protocol consists of standard immunosuppressant therapy, plasmapheresis, and intravenous immunoglobulin infusion. We have successfully performed transplantation in over 100 such patients with low complication rates.
Because these patients have been exposed to their donor's human leukocyte antigen (HLA) they are at high risk for both acute cellular and acute antibody-mediated rejection. This intent of this prospective, randomized, open-label trial is to determine whether induction therapy (i.e. therapy given at the time of transplantation for prophylaxis) with Thymoglobulin is associated with a lower 6-month incidence of acute cellular and antibody-mediated rejection than with our standard therapy, daclizumab.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Thymoglobulin
Thymoglobulin was administered as 1.5 mg/kg prior to reperfusion followed by 6 post-operative doses on days 1 through 6.
Thymoglobulin
Plasmapheresis
Following each plasmapheresis session, 100 mg/kg of Cytogam (CMVIg) (Cytogam, CSL Behring, King of Prussia, PA) was administered
Mycophenolate mofetil
2 gm/day. Standard of care
Tacrolimus
To achieve serum level of 8-10 ng/ml.
Dexamethasone
100 mg intra-operatively, and 25 mg every 6h post-operatively for six doses
Prednisone
Taper over three months to 5 mg daily
Cytogam
Following each plasmapheresis session, 100 mg/kg of Cytogam (CMVIg) (Cytogam, CSL Behring, King of Prussia, PA) was administered
Daclizumab
Daclizumab was administered as 2 mg/kg prior to reperfusion followed by 1 mg/kg every other week for 8 weeks post-operatively (4 post-operative doses).
Daclizumab
Plasmapheresis
Following each plasmapheresis session, 100 mg/kg of Cytogam (CMVIg) (Cytogam, CSL Behring, King of Prussia, PA) was administered
Mycophenolate mofetil
2 gm/day. Standard of care
Tacrolimus
To achieve serum level of 8-10 ng/ml.
Dexamethasone
100 mg intra-operatively, and 25 mg every 6h post-operatively for six doses
Prednisone
Taper over three months to 5 mg daily
Cytogam
Following each plasmapheresis session, 100 mg/kg of Cytogam (CMVIg) (Cytogam, CSL Behring, King of Prussia, PA) was administered
Interventions
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Thymoglobulin
Daclizumab
Plasmapheresis
Following each plasmapheresis session, 100 mg/kg of Cytogam (CMVIg) (Cytogam, CSL Behring, King of Prussia, PA) was administered
Mycophenolate mofetil
2 gm/day. Standard of care
Tacrolimus
To achieve serum level of 8-10 ng/ml.
Dexamethasone
100 mg intra-operatively, and 25 mg every 6h post-operatively for six doses
Prednisone
Taper over three months to 5 mg daily
Cytogam
Following each plasmapheresis session, 100 mg/kg of Cytogam (CMVIg) (Cytogam, CSL Behring, King of Prussia, PA) was administered
Eligibility Criteria
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Inclusion Criteria
* End-stage renal disease
* Identified to have positive lymphocytotoxic crossmatch or flow cytometric crossmatch with live donor
Exclusion Criteria
* Pregnancy
* Active infection
* History of cancer within the past two years (with the exception of non-melanomatous skin cancer)
* History of heparin induced thrombocytopenia
* Medical contraindications to transplant procedure
18 Years
ALL
No
Sponsors
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Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Robert A Montgomery, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University , SOM
Christopher E Simpkins, M.D.
Role: STUDY_DIRECTOR
Johns Hopkins University, SOM
Locations
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The Johns Hopkins University, School of Medicine
Baltimore, Maryland, United States
Countries
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References
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Haas M, Sis B, Racusen LC, Solez K, Glotz D, Colvin RB, Castro MC, David DS, David-Neto E, Bagnasco SM, Cendales LC, Cornell LD, Demetris AJ, Drachenberg CB, Farver CF, Farris AB 3rd, Gibson IW, Kraus E, Liapis H, Loupy A, Nickeleit V, Randhawa P, Rodriguez ER, Rush D, Smith RN, Tan CD, Wallace WD, Mengel M; Banff meeting report writing committee. Banff 2013 meeting report: inclusion of c4d-negative antibody-mediated rejection and antibody-associated arterial lesions. Am J Transplant. 2014 Feb;14(2):272-83. doi: 10.1111/ajt.12590.
Solez K, Colvin RB, Racusen LC, Haas M, Sis B, Mengel M, Halloran PF, Baldwin W, Banfi G, Collins AB, Cosio F, David DS, Drachenberg C, Einecke G, Fogo AB, Gibson IW, Glotz D, Iskandar SS, Kraus E, Lerut E, Mannon RB, Mihatsch M, Nankivell BJ, Nickeleit V, Papadimitriou JC, Randhawa P, Regele H, Renaudin K, Roberts I, Seron D, Smith RN, Valente M. Banff 07 classification of renal allograft pathology: updates and future directions. Am J Transplant. 2008 Apr;8(4):753-60. doi: 10.1111/j.1600-6143.2008.02159.x. Epub 2008 Feb 19.
Other Identifiers
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IRB00078055
Identifier Type: -
Identifier Source: org_study_id
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