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Comparison of Alemtuzumab/Tacrolimus Versus Interleukin-2 Receptor (IL-2R) Monoclonal Antibody (MoAb)/Tacrolimus/Mycophenolate in Kidney Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00246129
Recruitment Status : Unknown
Verified May 2008 by Hammersmith Hospitals NHS Trust.
Recruitment status was:  Active, not recruiting
First Posted : October 30, 2005
Last Update Posted : May 12, 2008
Information provided by:
Hammersmith Hospitals NHS Trust

Brief 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 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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Kidney Diseases Kidney Failure Drug: Alemtuzumab Drug: Daclizumab Phase 4

Detailed Description:


The St Mary's Hospital Renal Unit (now combined with the Hammersmith Hospital Renal Unit at the West London Renal and Transplant Centre) introduced Tacrolimus based immunosuppression in 1995, developing a steroid avoidance regimen based on Tacrolimus, Mycophenolate, and IL-2R MoAb between 2000 and 2002, and moving to Campath-1H as an induction agent in 2004. Results over this period have been excellent with five and ten year survivals with functioning graft rates of 82% and 72% for the first 260 cadaveric kidney transplants performed since 1995.

The two most recent regimens used at St Mary's have both produced very low (< 10%) rejection rates, and very good (> 90%) short−term rejection-free patient and graft survival rates. Between 2002 and 2004, the regimen consisted of induction with an IL2-Receptor blocking monoclonal antibody with Tacrolimus and Mycophenolate as long term maintenance therapy. In patients without rejection steroid usage was limited to the first 7 days post−transplant. The current regimen uses Campath-1H (which is now well established as an induction agent in renal transplantation for induction), with Tacrolimus monotherapy maintenance and an identical short-course steroid regimen.


The IL2R MoAb/Tacrolimus/Mycophenolate/Short−course steroids regimen (2002−2004 Regimen 1) has the advantage of flexibility in terms of adjusting maintenance therapy to allow clinical response to patients and transplants with different tolerance of the two maintenance agents, but involves increased expense in terms of using and monitoring the blood levels of two modern (and hence expensive) agents. In addition, patients have long−term exposure to the anti−proliferative agent Mycophenolate, which can be associated with increased risk of infection, gastrointestinal side effects, and skin malignancies.

The Campath-1H/Tacrolimus/Short−course steroids regimen (2004−current, Regimen 2) has the advantage of highly effective immunosuppression in the initial 3−month period, allowing lower doses of the potentially nephrotoxic Tacrolimus to be used, and simplicity, but exposes patients to a period of several months of lymphopenia (reduced lymphocyte counts in the blood) after Campath administration, and reliance on Tacrolimus monotherapy for maintenance which might lead to greater long term Tacrolimus exposure.


In order to allow a proper comparison of these two anti−rejection treatment combinations we propose a randomised trial which will enable us to consider the relative merits of the two regimens without the introduction of bias associated with using historical control groups. Transplant recipients will be randomised in a 1:2 ratio to regimen 1 and regimen 2.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomised Controlled Comparison of Campath−Tacrolimus vs IL2R MoAb−Tacrolimus/MMMF in Kidney Transplantation
Study Start Date : October 2005
Estimated Primary Completion Date : April 2009
Estimated Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Campath induction with 7-day short-course steroids followed by tacrolimus monotherapy
Drug: Alemtuzumab
Monoclonal antibody induction therapy
Other Name: Campath 1-H

Experimental: 2
Daclizumab induction with 7-day short-course steroids followed by Tacrolimus and Mycophenolate mofetil therapy
Drug: Daclizumab
Monoclonal antibody induction therapy

Primary Outcome Measures :
  1. One year survival with a functioning graft [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Occurrence, severity, and type of rejection episodes [ Time Frame: 1 year ]
  2. Occurrence, severity, and type of infection episodes [ Time Frame: 1 year ]
  3. Initial length of stay in hospital and subsequent admissions [ Time Frame: 1 year ]
  4. Cost over the first year of the two therapies [ Time Frame: 1 year ]
  5. Presence in the blood of cells which might trigger rejection in, or promote tolerance to the graft [ Time Frame: 3 years ]
  6. Early development of scarring in the grafts [ Time Frame: 1 year ]
  7. Graft function [ Time Frame: 2 years ]
  8. Patient survival and graft survival censored for death with function [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Kidney transplant recipients under the care of the West London Renal and Transplant Centre

Exclusion Criteria:

  • Patients who are unable to give written informed consent
  • Simultaneous kidney/pancreas transplant recipients
  • Non−heart beating deceased donor transplant recipients
  • Patients who would not be offered Campath-1H induction under our current protocol (patients with previous malignancy or with previous exposure to cytotoxic or antiproliferative agents)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00246129

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United Kingdom
West London Renal and Transplant Centre, 4th Floor Ham House, Hammersmith Hospital
London, United Kingdom, W12 OHS
Sponsors and Collaborators
Hammersmith Hospitals NHS Trust
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Principal Investigator: Adam G McLean, FRCP, DPhil Hammersmith Hospital NHS Trust
Study Director: David H Taube, MBBCh, FRCP Hammersmith Hospital NHS Trust
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Responsible Party: Dr Adam McLean, West London Renal & Transplant Centre Identifier: NCT00246129    
Other Study ID Numbers: SMHREN0501
EUdraCT 2005−002856−17
First Posted: October 30, 2005    Key Record Dates
Last Update Posted: May 12, 2008
Last Verified: May 2008
Keywords provided by Hammersmith Hospitals NHS Trust:
Kidney Transplantation
Kidney Disease
Kidney Failure
Graft Rejection
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency
Urologic Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs