NCT00275509

Induction Therapy Study in Live Donor Kidney Transplant Recipients With a Positive Crossmatch

Open Label Randomized Study of Thymoglobulin Versus Daclizumab Induction Therapies for the Reduction of Acute Rejection in Live Donor Kidney Transplant Recipients With a Positive Crossmatch

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether the anti-T cell antibody, Thymoglobulin is a more effective induction medication than the anti-IL-2R inhibitor daclizumab, in kidney transplant recipients who have a positive crossmatch with their live donor.

Detailed description

Kidney transplantation is widely recognized as the optimal therapy for the management of end-stage renal disease. Presently, the deceased donor kidney waiting list has expanded disproportionately with the number of transplant procedures that are performed in the United States. To further compound this problem, as many as 1/3 of the patients on this list are highly sensitized against a broad range of potential donors. 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

• Kidney Failure, Chronic

Interventions

Type	Name	Description
DRUG	Thymoglobulin
DRUG	Daclizumab
OTHER	Plasmapheresis	Following each plasmapheresis session, 100 mg/kg of Cytogam (CMVIg) (Cytogam, CSL Behring, King of Prussia, PA) was administered
DRUG	Mycophenolate mofetil	2 gm/day. Standard of care
DRUG	Tacrolimus	To achieve serum level of 8-10 ng/ml.
DRUG	Dexamethasone	100 mg intra-operatively, and 25 mg every 6h post-operatively for six doses
DRUG	Prednisone	Taper over three months to 5 mg daily
DRUG	Cytogam	Following each plasmapheresis session, 100 mg/kg of Cytogam (CMVIg) (Cytogam, CSL Behring, King of Prussia, PA) was administered

Timeline

• Start date: 2007-01-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2006-01-12
• Last updated: 2018-01-18
• Results posted: 2017-12-20

Locations

1 site across 1 country: United States