Phase 4
Completed N=123
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.
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
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Kidney transplantation with minimized maintenance: alemtuzumab induction with tacrolimus monotherapy--an open label, randomized trial.
Outcome Measures
| Outcome | Result | p-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)
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.