Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hammersmith Hospitals NHS Trust; Imperial College Healthcare NHS Trust
• Treatments: Alemtuzumab; Tacrolimus

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