Clinical Trials Logo
  1. Home
  2. Renal Transplantation
  3. NCT00579592

Campath, Rituximab, and Myfortic With Short-Course Calcineurin Inhibitor Therapy in Renal Transplanation

Renal Transplantation Clinical Trial

Official title:
A Pilot Study of Campath-1H Induction Therapy Combined With Rituximab®, Myfortic™ and a Short Course of Calcineurin Inhibitor Therapy to Allow for a Long Term Calcineurin Inhibitor Free Regimen After Renal Transplantation

Clinical Trial Summary

The hypothesis of this study is that lymphocyte depletion by Campath-1H and rituximab will obviate the need for long-term calcineurin inhibitors in renal transplantation. Most successful strategies to date have relied on the use of either tacrolimus or cyclosporine for an indefinite period of time. However, the advantage of a long term, calcineurin inhibitor free regimen may include improved renal allograft function, a lower incidence of hypertension, diabetes, and less drug related side effects. This is a non-randomized open-label pilot trial in 30 adult renal transplant patients. Subjects will receive 2 doses of Campath-1H (30mg given on Day 0 and Day 1) and a single dose of Rituximab (375mg/m2) on Day 0, given intra-operative. Subjects will take maintenance doses of prednisone and enteric coated mycophenolate sodium (Myfortic™). Subject will also be given cyclosporine (Neoral®) therapy for approximately 2 weeks (10-20 days).

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00579592
Study type Interventional
Source University of Wisconsin, Madison
Contact
Status Terminated
Phase N/A
Start date April 2006
Completion date April 2007
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06026592 - Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients
Active, not recruiting NCT02444429 - 3-month Screening Biopsy to Optimize the Immunosuppression in Renal Transplantation Phase 3
Completed NCT02238418 - Efficacy of Usual Vitamin D Supplementation and Its Impact on Children and Adolescents Calciuria. Phase 4
Completed NCT01729494 - Belatacept Early Steroid Withdrawal Trial Phase 4
Terminated NCT01436305 - Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation Phase 2
Completed NCT02843295 - Catalytic Antibodies to Predict Uninvasively Late Transplant Failure N/A
Terminated NCT01276834 - Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation Phase 4
Completed NCT00842699 - Characterization of Immunological Profile of Renal Transplant Patients Undergoing Induction Treatment With Thymoglobulin vs. IL-2 Receptor Antagonist Basiliximab N/A
Completed NCT00525681 - Interaction Between Rimonabant and Cyclosporine and Tacrolimus Phase 4
Completed NCT00776750 - Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients Phase 4
Completed NCT00189735 - A Study to Evaluate FK778 in Kidney Transplant Patients Phase 2
Recruiting NCT04052867 - Intravenous Lignocaine Infusion in Laparoscopic Donor Nephrectomy N/A
Recruiting NCT03114826 - Study of the Impact of VEGF Polymorphism on the Development of Renal Carcinoma in Renal Transplant Patients N/A
Completed NCT02587052 - A 1-year Comparison of Generic Tacrolimus (Tacni) and Prograf in Renal Transplant Patients - a Retrospective Matched Pair Analysis, GenTac
Completed NCT02020642 - Effect of Renal Transplantation on Obstructive Sleep Apnea in End Stage Renal Disease Patients (SASinTx) N/A
Completed NCT01435291 - AADAPT - Analysis of Advagraf Dose Adaptation Post Transplantation Phase 4
Recruiting NCT01001065 - Association of the Intrarenal Resistance Index (RI) of Transplanted Kidneys With Generalized Atherosclerosis N/A
Completed NCT00978965 - Identification of Patients With High Probability of Poorly Responding to Therapy With Mycophenolic Acid Prodrugs
Recruiting NCT00903188 - Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation Phase 4
Completed NCT00400400 - Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance Phase 4