Phase 4
Completed N=102
Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation
End-stage Renal Failure · graft rejection
Source: ClinicalTrials.gov NCT00807144 ↗
Enrolled (actual)
102
Serious AEs
1.0%
Results posted
Aug 2021
Primary outcomePrimary: Patient Survival With a Functioning Graft — 92.3; 96 percent of participants — p=0.26
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The current anti-rejection drug regime for kidney transplant recipients in use at the West London Renal & Transplant Centre (WLRaTC) consists of induction therapy with the very potent monoclonal antibody Campath 1-H (Alemtuzumab) followed by long-term maintenance with the Calcineurin inhibitor Tacrolimus
The recent development (and licensing in the UK) of an extended-release, once daily formulation of Tacrolimus holds out the promise of simpler drug regimes for our patients. In the context of our current successful use of Tacrolimus monotherapy maintenance after Campath 1-H induction, the extended-release Tacrolimus formulation will enable us to offer a regime where the only long-term immunosuppressive treatment that most of our patients need will be a single drug, taken once a day.
The investigators wish to assess the efficacy of such a regime in a structured comparison with our current protocol.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Survival With a Functioning Graft |
92.3; 96 | 0.26 |
| SECONDARY Rejection-free Patient Survival With a Functioning Graft |
86; 84; 83.4; 80.1 | 0.48 |
| SECONDARY Patient-reported Quality of Life, and Medication Adherence |
— | — |
Eligibility Criteria
Inclusion Criteria
- Live donor kidney transplant recipients
- heart-beating-Deceased donor kidney transplant recipients
- Patients suitable for induction therapy with Alemtuzumab
Exclusion Criteria
- Recipients of Non-heart-beating deceased donor kidney transplants
- Recipients of simultaneous kidney/pancreas transplants
- ABO incompatible/desensitized transplant recipients
- Positive flow cross-match/desensitized transplant recipients
- Patients with heavy prior exposure to myelosuppressive therapy
- Patients with previous malignancy
- Patients with HIV,Hepatitis-C, or Hepatitis-B infection
Data sourced from ClinicalTrials.gov (NCT00807144). 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.