NCT00214266

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

2.6 years

First QC Date

September 13, 2005

Last Update Submit

May 29, 2018

Conditions

Renal Transplantation

Outcome Measures

Primary Outcomes (1)

  • renal allograft function

    2 years

Secondary Outcomes (3)

  • incidence of hypertension

    2 years

  • incidence of diabetes

    2 years

  • drug related side effects

    2 years

Study Arms (1)

Campath-1H Induction Therapy Combined With CellCept® Therapy

EXPERIMENTAL

Campath-1H Induction Therapy Combined With CellCept® Therapy

Drug: Campath 1H®, Rituximab, mycophenolate mofetil

Interventions

Campath 1H®, Rituximab, mycophenolate mofetilDRUG

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

Campath-1H Induction Therapy Combined With CellCept® Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • renal transplant recipients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Interventions

AlemtuzumabRituximabMycophenolic Acid

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsAntibodies, Monoclonal, Murine-DerivedCaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

Study Officials

  • Hans Sollinger, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

January 1, 2005

Primary Completion

August 1, 2007

Study Completion

September 1, 2007

Last Updated

May 30, 2018

Record last verified: 2018-05

Locations

US(1)