Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to determine if administration of rituximab blocks the development of donor specific antibodies (DSA) in transplant recipients who have developed renal dysfunction and DSA after renal transplant. It is hoped that by blocking DSA production renal function will stabilize or improve.


Clinical Trial Description

A long established risk factor for late renal allograft loss is the development of DSA. Recent studies from our group and others have shown that these antibodies are probably responsible for chronic rejection by attacking the vascular endothelium and fixing complement (detected as C4d in renal biopsies). Studies in humans and monkeys have shown that circulating antibody and complement deposition precede the development of chronic graft injury. Interruption of antibody production is a potential beneficial strategy to prevent late graft loss from this mechanism. Therapeutic regimens that have been used in an attempt to deplete HLA or ABO antibodies include plasmapheresis, IVIg, tacrolimus and mycophenolate mofetil (MMF), and anti-CD20 (rituximab). Of these regimens, the most specific is anti-CD20, rituximab (rituxan), a therapy now FDA approved for B cell proliferative diseases. Although initially introduced for the treatment of neoplasm, the humoral immunosuppressant effects of rituximab have been shown to have clinical significance. Rituximab interferes with both primary and secondary humoral responses by eliminating B-cells prior to antigen exposure, thus interfering with differentiation into antibody secreting cells and specific antibody production. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00261547
Study type Interventional
Source Massachusetts General Hospital
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date December 2005
Completion date November 2007

See also
  Status Clinical Trial Phase
Terminated NCT03840343 - Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease Phase 1
Completed NCT02964429 - Determination In-vivo KUF for Diacap Pro Hemodialyser N/A
Recruiting NCT04485845 - Metformin Versus Vildagliptin in Reducing Risk of Metabolic Syndrome Complications Progression Phase 4
Completed NCT01083849 - Long-Term Therapy Outcomes When Treating Chronic Kidney Disease (CKD) Patients With Paricalcitol in German and Austrian Clinical Practice N/A
Withdrawn NCT00476515 - Rituximab Therapy for Patients on Kidney Transplant Waiting List With Positive Donor Specific Crossmatch to Living Donor Phase 1
Completed NCT04594161 - Effectiveness of Drainage by PCN vs. JJ in Patients With Symptoms of Obstructive Kidney Disease Caused by Urolithiasis N/A
Terminated NCT04626427 - The WavelinQâ„¢ Arterio-Venous Endovascular Fistula: A Global, Post-Market Investigation N/A
Recruiting NCT04058951 - Plant Versus Animal Dietary Protein and the Effect on Proteinuria N/A