Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In a healthy person, the kidneys are responsible for filtering out the waste products and excess water in the blood, and converting them into urine. If the kidneys suddenly stop working (acute kidney injury) or are suffering from severe, long-term disease of the kidneys (chronic kidney failure) then the body is unable to get rid of the waste products building up in the blood. In some patients, the damage to the kidneys becomes worse over time and so a kidney transplant is their only real option. When a person receives a kidney transplant, they have to take drugs called immunosuppressants, to prevent their immune system rejecting the new kidney (graft). Treatment with these drugs have managed to lower the rate of acute rejection (when the body’s immune system rejects the transplant almost immediately), however the long-term survival of kidney transplants has not really improved over the past decade. The commonest cause of graft loss is a condition called chronic allograft nephropathy (CAN) where the graft itself dies over time due to long-term treatment with calcineurin inhibitors (a type of immunosuppressant medication). They work by stopping the activity of a protein called calcineurin which is involved in activating the certain cells of the immune system. A possible way to prevent this is to lower the amounts of calcineurin patients are taken by replacing them with other medications. This study is going to look at the long-term effects of Campath-1H (an initial immunosuppressant treatment that is not a calcineurin inhibitor) and sirolimus (a maintainance immunosuppressant treatment that is not a calcineurin inhibitor) to the standard treatments of the drugs basiliximab (standard treatment) and tacrolimus (a maintainance immunopsupressent that is a calcineurin inhibitor)

Who can participate?
Adults who are scheduled to receive kidney transplant in next 24 hours

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are treated with two doses of 30mg Campath-1H intravenously (directly into a vein) or subcutaneously (injection into the skin) 24 hours apart as well as taking tacrolimus tablets every day at a dose of 5-7 ng/ml for 6 months. Those in the second group are treated with two doses of 20mg basiliximab intravenously (directly into a vein) spaced four days apart (standard treatment) as well as tacrolimus tablets every day at a dose of 5-12 ng/ml for 6 months. After 6 months, the two groups are randomly allocated to subgroups. From the first group, half of the participants continue taking tacrolimus tablets every day and the other half are given sirolimus tablets to take every day at a dose of 5-10 ng/ml for first 6 months then 5-8 ng/ml. From the second group, half of the particpants continue to take tacrolimus tablets but at a dose of 5-8 ng/ml, and the other half are given sirolimus tablets to take every day at a dose of 5-10 ng/mL for first 6 months, then 5-8 ng/ml. For all groups, study treatments continue (prescribed by the participant's doctor) while their transplant remains functional. All participants are reviewed when they are discharged from hospital and at 1, 3, 6, 9, and 12 months after transplantation, in order to determine the transplant failure rate.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
1. Clinical Trial Service Unit, Oxford Transplant Centre (UK)
2. University of Oxford (UK)

When is the study starting and how long is it expected to run for?
September 2010 to August 2017

Who is funding the study?
1. NHS Blood and Transplant Research and Development (UK)
2. Pfizer (UK)
3. Novartis (UK)

Who is the main contact?
Professor Peter Friend

Trial website

Contact information



Primary contact

Prof Peter Friend


Contact details

Oxford Transplant Centre
Churchill Hospital
United Kingdom
+44 1865 743743

Additional identifiers

EudraCT number

2008-008553-27 number


Protocol/serial number


Study information

Scientific 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


The 3C Study

Study hypothesis

Reducing exposure to calcineurin inhibitors either by using more potent antibody induction (Campath) and/or an elective switch to sirolimus-based immunosuppression may improve function and survival of kidney transplants.

Ethics approval

Nottingham Research Ethics Committee (REC) 2 approved on the 2nd of December 2009 (ref: 09/H0408/101)

Study design

Open label multicentre randomised controlled 2x2 factorial trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet


Kidney transplantation


1. Campath-1H: 30 mg on days 0 and 1 (intravenously or subcutaneously)
2. Basiliximab 20mg on days 0 and 4 (intravenously)
3. Tacrolimus: oral tablets
3.1. target trough level 8-12 ng/mL following basiliximab induction for first six months
3.2. target trough level 5-7 ng/mL following Campath-1H induction and in all patients after 6 months, for duration of study.
4. Sirolimus: oral tablets; target trough level 5-10 ng/mL for first 6 months then 5-8 ng/mL. For duration of study.
The total duration of follow up is at least 5 years for all treatment arms.

Intervention type



Not Specified

Drug names

Campath-1H, basiliximab, tacrolimus, sirolimus

Primary outcome measures

1. Induction therapy comparison: biopsy-proven acute rejection during the first 6 months after transplantation
2. Maintenance therapy comparison: graft function is measured by estimated glomerular filtration rate at 2 years after transplantation

Secondary outcome measures

All secondary outcomes are assessed using a a study-specific questionnaire that has been devised to send to patients and the review of the UK Renal Registry, Hospital Episode Statistics, Office for National Statistics, National Cancer Registry and UK Transplant Registry at 1, 2 and 5 years.

1. Graft function and survival
2. Patient survival
3. Incidence of serious infections
4. Incidence of malignancy
5. Major vascular events

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Men or women aged over 18 years
2. Recipient of kidney transplant from live or deceased donor

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Recipients of multi-organ transplants
2. Previous treatment with Campath-1H
3. Active infection
4. Past history of anaphylaxis to humanized monoclonal antibodies
5. History of malignancy (except for adequately treated non-melanoma skin cancer)
6. Loss of previous transplant within 6 months not due to technical reasons
7. Medical history that might limit the participant's ability to take trial treatments for the duration of the study

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Oxford Transplant Centre
Churchill Hospital Old Rd Headington
United Kingdom

Trial participating centre

Clinical Trial Service Unit (CTSU) Richard Doll Building
Clinical Trial Service Unit (CTSU) Richard Doll Building Old Road Campus Headington
United Kingdom

Sponsor information


University of Oxford (UK)

Sponsor details

Research Services
Clinical Trials and Research Governance
Manor House
John Radcliffe Site
United Kingdom
+44 (0)1865 270000

Sponsor type




Funder type


Funder name

NHS Blood and Transplant Research and Development (UK) (ref 09-15-01-03)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Pfizer (UK)

Alternative name(s)

Pfizer Inc.

Funding Body Type

private sector organisation

Funding Body Subtype



United States of America

Funder name

Novartis (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype




Results and Publications

Publication and dissemination plan

Planned publication of results and maintenance comparison primary outcome results in a peer reviewed journal.

Intention to publish date


Participant level data

Available on request

Results - basic reporting

Publication summary

2014 results in:

Publication citations

  1. Results

    Alemtuzumab-based induction treatment versus basiliximab-based induction treatment in kidney transplantation (the 3C Study): a randomised trial., Lancet, 2014, doi: 10.1016/S0140-6736(14)61095-3.

Additional files

Editorial Notes

18/02/2016: The recruitment dates have been updated from 01/09/2010 - 31/08/2017 to 04/10/2016 - 31/08/2017. The methods of meaurement used to measure the secondary outcome measures have now also been included. In addition, the Clinical Trial Service Unit at the University of Oxford has been added as a trial participating centre and the study website has been added.