NCT01120028

Campath, Calcineurin Inhibitor Reduction and Chronic Allograft Nephropathy

Open-label, Randomised Multicentre Study of CAMPATH-1H Versus Basiliximab Induction Treatment and Sirolimus Versus Tacrolimus Maintenance Treatment for the Preservation of Renal Function in Patients Receiving Kidney Transplants

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 852 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The 3C study is investigating whether reducing exposure to calcineurin inhibitors (by using more potent antibody induction treatment and/or an elective switch to sirolimus) can improve the function and survival of kidney transplants.

Detailed description

The long-term survival of kidney transplants has not improved over the past decade despite reductions in the rate of acute rejection. The commonest cause of late graft loss is chronic allograft nephropathy which is frequently caused by calcineurin inhibitor toxicity. Therefore, it may be possible to improve long-term graft outcomes by reducing the amount of calcineurin inhibitor exposure. Two possible strategies to do this were tested. Firstly, Campath-1H (a monoclonal lymphocyte-depleting antibody) was compared to standard basiliximab-based induction. All patients then received tacrolimus-based maintenance therapy for 6-months (using lower doses in the Campath-1H arm). At six months, patients were re-randomized between remaining on tacrolimus and converting to sirolimus (and therefore no longer taking calcineurin inhibitors). Patients were then followed-up in clinic and through routine NHS registries to collect information on relevant outcomes (including graft function, survival, hospitalisations and death).

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Alemtuzumab	Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart
DRUG	Basiliximab	20 mg intravenously, two doses 96 hours apart
DRUG	Sirolimus	Sirolimus: target trough levels 6-12 ng/mL for first 6-months after maintenance therapy randomization, then 5-10 ng/mL
DRUG	Tacrolimus	Tacrolimus: target trough levels 5-7 ng/mL after maintenance therapy randomization.

Timeline

• Start date: 2010-09-01
• Primary completion: 2014-02-01
• Completion: 2020-03-01
• First posted: 2010-05-10
• Last updated: 2020-04-02
• Results posted: 2019-10-01

Locations

20 sites across 1 country: United Kingdom