A Pilot Study of Campath-1H Induction Therapy Combined With CellCept® Therapy to Allow for a Calcineurin Inhibitor Free Regimen After Renal Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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. However, the advantage of a 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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Campath-1H Induction to Allow Discontinuation of Calcineurin Inhibitors After Renal Transplantation

NCT00214201

Primary Renal Transplant

COMPLETED NA

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

NCT00579592

Acute Rejection Renal Transplantation

TERMINATED NA

Campath-1H Induction to Allow Steroid Free Immunosuppression in Pediatric Renal Transplantation

NCT00167661

TERMINATED PHASE1/PHASE2

Safety in Immunomodulatory Functions of Alemtuzumab (Campath) in Pediatric Kidney Transplantation Recipients

NCT00240994

Kidney Failure, Chronic Kidney Transplantation Immunosuppression

COMPLETED PHASE2

Treatment of Children With Kidney Transplants by Injection of CD4+CD25+FoxP3+ T Cells to Prevent Organ Rejection

NCT01446484

End-Stage Renal Disease Kidney Failure

UNKNOWN PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Transplantation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Campath-1H Induction Therapy Combined With CellCept® Therapy

Group Type EXPERIMENTAL

Campath 1H®, Rituximab, mycophenolate mofetil

Intervention Type DRUG

Induction therapy with Campath 30mg IV x 2 doses, Rituximab 375mg/m2 x 1, corticosteroids, and mycophenolate 1000mg bid

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Campath 1H®, Rituximab, mycophenolate mofetil

Induction therapy with Campath 30mg IV x 2 doses, Rituximab 375mg/m2 x 1, corticosteroids, and mycophenolate 1000mg bid

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* renal transplant recipients

Exclusion Criteria

* Recipients of HLA-identical living-donor renal transplants;
* multi-organ transplant;
* known hypersensitivity to Campath-1H, Rituximab, CellCept, or prednisone;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No