Overview

This trial is active, not recruiting.

Condition kidney transplantation
Treatments alemtuzumab, basiliximab, sirolimus, tacrolimus
Phase phase 2/phase 3
Targets CD52, mTOR
Sponsor University of Oxford
Collaborator National Health Service, United Kingdom
Start date September 2010
End date February 2014
Trial size 800 participants
Trial identifier NCT01120028, 2008-008553-27, CTSU3C1, ISRCTN88894088

Summary

The 3C study will investigate 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Induction therapy allocation: Campath-1H Maintenance therapy allocation (at 6 months post-transplant): Sirolimus
alemtuzumab Campath-1H
Alemtuzumab 30 mg intravenously or subcutaneously Two doses 24 hours apart
sirolimus Rapamune
Sirolimus: target trough levels 5-10 ng/mL for first 6 months, then 5-8 ng/mL
(Experimental)
Induction therapy allocation: Campath-1H Maintenance therapy allocation (at 6 months post-transplant): Tacrolimus
alemtuzumab Campath-1H
Alemtuzumab 30 mg intravenously or subcutaneously Two doses 24 hours apart
tacrolimus Prograf
Target trough level 5-12 ng/mL for first 6 months after basiliximab; 5-7 ng/mL for first six months after basiliximab. 5-7 ng/mL for all participants after 6 months.
(Active Comparator)
Induction therapy allocation: Basiliximab Maintenance therapy allocation (at 6 months post-transplant): Tacrolimus
basiliximab Simulect
20 mg intravenously Two doses 96 hours apart
tacrolimus Prograf
Target trough level 5-12 ng/mL for first 6 months after basiliximab; 5-7 ng/mL for first six months after basiliximab. 5-7 ng/mL for all participants after 6 months.
(Active Comparator)
Induction therapy allocation: Basiliximab Maintenance therapy allocation (at 6 months post-transplant): Sirolimus
basiliximab Simulect
20 mg intravenously Two doses 96 hours apart
sirolimus Rapamune
Sirolimus: target trough levels 5-10 ng/mL for first 6 months, then 5-8 ng/mL

Primary Outcomes

Measure
Biopsy-proven acute rejection
time frame: 6 months
Graft function
time frame: 2 and 5 years post-transplantation

Secondary Outcomes

Measure
Graft survival
time frame: 6 months, 2 and 5 years
Serious infection
time frame: 2 and 5 years
Malignancy
time frame: 2 and 5 years
Major vascular event
time frame: 2 and 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - men or women aged over 18 years - recipient of kidney transplant (planned in next 24 hours) Exclusion Criteria: - recipients of multi-organ transplant - previous treatment with Campath-1H - active infection (including HIV, hepatitis B or C) - history of anaphylaxis to humanized monoclonal antibody - history of malignancy (except adequately treated non-melanoma skin cancer) - loss of kidney transplant within 6 months not due to technical reasons - medical history that might limit the individual's ability to take trial treatments for the duration of the study

Additional Information

Official title 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
Principal investigator Colin Baigent
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 will be tested. Firstly, Campath-1H (a monoclonal lymphocyte-depleting antibody) will be compared to standard basiliximab-based induction. All patients will then receive tacrolimus-based maintenance therapy for 6 months (using lower doses in the Campath-1H arm). At six months, patients will be re-randomised between remaining on tacrolimus and converting to sirolimus (and therefore no longer take calcineurin inhibitors). Patients will then be followed-up in clinic and through routine NHS registries to collect information on relevant outcomes (including graft function, survival, hospitalisations and death).
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Oxford.