Clinical Trials Logo
  1. Home
  2. Other
  3. NCT00275509

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

Kidney Failure, Chronic Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00275509
Study type Interventional
Source Johns Hopkins University
Contact
Status Completed
Phase Phase 3
Start date January 2007
Completion date June 2010
View Details
See also
  Status Clinical Trial Phase
Completed NCT03246984 - VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ N/A
Completed NCT02922361 - Spending and Outcomes for Complex Medicare Advantage Patients
Completed NCT02235571 - iChoose Decision Kidney Aid for End-Stage Renal Disease Patients N/A
Completed NCT01933789 - Improving Communication About Serious Illness N/A
Completed NCT01930396 - Use of Tinzaparin for Anticoagulation in Hemodialysis Phase 4
Completed NCT01922843 - A Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis Phase 2
Not yet recruiting NCT01674660 - Factors Associated With Interdialytic Blood Pressure Variability in Maintenance Hemodialysis Patients N/A
Not yet recruiting NCT01157260 - The Effects of AST-120 on Endothelial Dysfunction in Patients With Chronic Kidney Disease Phase 4
Completed NCT01209403 - Insulin-like Growth Factor (IGF-I) in Hemodialysis Patients Phase 4
Completed NCT00753116 - Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension Phase 1
Recruiting NCT00532688 - N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure Phase 2/Phase 3
Completed NCT00528788 - How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis Phase 4
Completed NCT00534144 - Comparison Between Effects of Two Iron Preparations on Protein in the Urine Phase 1
Completed NCT00382044 - Audit of the Effect of Changing From IV to SC Administration of ESA's in Haemodialysis Patients N/A
Completed NCT00226902 - Vascular Reactivity in Kidney Disease Patients N/A
Recruiting NCT00235287 - Pulse Wave Velocity, Pulse Wave Morphology and Blocking of the Reninangiotensin System in Patients With Chronic Kidney Disease Phase 4
Completed NCT00224081 - DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin) Phase 4
Completed NCT00071214 - Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis Phase 3
Completed NCT00049907 - Cardiac and Renal Disease Study (CARDS) N/A
Completed NCT00006297 - Risk Factors for CV Disease in a Dialysis Cohort N/A