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Phase 4 Completed N=123 Randomized Prevention

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

Source: ClinicalTrials.gov NCT00246129 ↗
Enrolled (actual)
123
Serious AEs
8.1%
Results posted
Sep 2021
Primary outcomePrimary: One Year Survival With a Functioning Graft — 97.6; 95.1 Percent of patients — p=0.467
◆ Published Evidence
Established
52citations · ~3 / year
Kidney transplantation with minimized maintenance: alemtuzumab induction with tacrolimus monotherapy--an open label, randomized trial.
Transplantation · 2011 · High-confidence link

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.

Linked Publications

  • Kidney transplantation with minimized maintenance: alemtuzumab induction with tacrolimus monotherapy--an open label, randomized trial.
    Transplantation · 2011 · 52 citations · High-confidence link

Outcome Measures

OutcomeResultp-value
PRIMARY
One Year Survival With a Functioning Graft
97.6; 95.1 0.467
SECONDARY
Occurrence of Rejection Episodes
91.2; 82.3 0.138
SECONDARY
Occurrence of Significant Episodes of Infection
73; 76
SECONDARY
Initial Length of Stay in Hospital
11.7; 12.1
SECONDARY
Presence in the Blood of Cells Which Might Trigger Rejection in, or Promote Tolerance to the Graft
SECONDARY
Early Development of Scarring in the Grafts
96; 90
SECONDARY
Graft Function: Level of Creatinine
127.3; 147.0
SECONDARY
Patient Survival Censored for Death With Function
98; 98
SECONDARY
Graft Survival Censored for Death With Function
91; 95

Eligibility Criteria

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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00246129) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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