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CamTac Trial:Campath-Tacrolimus vs IL2R MoAb/Tacrolimus/MMF in Renal Transplantation

NCT00246129 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2021-09-29

Study results available
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Summary

The advent of new, potent immunosuppressive (anti-rejection) drugs over the past ten years has substantially reduced the risk of rejection after kidney transplantation, has allowed the development of immuno-suppressive regimens that do not use long-term steroids (steroid avoidance), and has improved transplant success rates both in the short and medium term.

The main new agents used in these modern regimens are the calcineurin inhibitor (CNI) tacrolimus; the anti-proliferative agent mycophenolate; and induction agents which are used to provide effective early suppression of the rejection process; these include monoclonal antibodies (MoAb) such as IL-2 receptor blocking antibodies (IL-2R MoAb: basiliximab and daclizumab) and the anti-CD52 antibody Campath-1H (alemtuzumab).

Although almost all modern immunosuppressive regimens involve one or more of these agents, it is not known which is the safest and most effective combination.

This randomised controlled trial compares two steroid sparing regimens which have been used with very good short and medium term results at St Mary's Hospital Renal and Transplant Unit over the last 5 years. The primary hypothesis is that the alemtuzumab/tacrolimus regimen is as effective and safe as the IL-2R MoAb/tacrolimus/mycophenolate regimen.

Conditions

Interventions

DRUG

Campath

Monoclonal antibody induction therapy

DRUG

Daclizumab

Monoclonal antibody induction therapy

Sponsors & Collaborators

  • EMagnusson

    lead OTHER

Principal Investigators

  • Adam G McLean, FRCP, DPhil · Hammersmith Hospital NHS Trust

  • David H Taube, MBBCh, FRCP · Hammersmith Hospital NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00246129 on ClinicalTrials.gov