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Kidney TransplantationPhase 2/33CNCT01120028

Campath, Calcineurin Inhibitor Reduction and Chronic Allograft Nephropathy

A Phase 2/3 study testing Alemtuzumab, Basiliximab and Sirolimus in people with Kidney Transplantation, run by University of Oxford at 20 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Transplantation
What is being tested?
Alemtuzumab, Basiliximab and Sirolimus
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
852 participants
Where
20 sitesUnited Kingdom
Study dates
Sep 2010to Mar 2020
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • men or women aged over 18 years
  • recipient of kidney transplant (planned in next 24 hours)

Who cannot join

  • 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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United Kingdom20 sites

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham

  • Addenbrooke's Hospital NHS Trust

    Cambridge

  • University Hospital of Wales

    Cardiff

  • University Hospitals Coventry & Warwickshire

    Coventry

  • Royal Infirmary

    Edinburgh

  • Western Infirmary

    Glasgow

  • Hull and East Yorkshire Hospitals NHS Trust

    Hull

  • Leeds Teaching Hospitals NHS Trust

    Leeds

  • Royal Liverpool and Broadgreen University Hospitals NHS Trust

    Liverpool

  • Bart's and the London NHS Trust

    London

  • Guy's and St Thomas's NHS Trust

    London

  • Kings College Hospital NHS Trust

    London

  • Royal Free Hampstead NHS Trust

    London

  • Central Manchester NHS Trust

    Manchester

  • Newcastle-upon-Tyne Hospitals NHS Trust

    Newcastle

  • Nottingham University Hospitals NHS Trust

    Nottingham

  • Oxford Radcliffe Hospitals NHS Trust

    Oxford, Oxon, OX3 7LJ

  • Plymouth Teaching Hospitals NHS Trust

    Plymouth

  • Portsmouth Hospitals NHS Trust

    Portsmouth

  • Sheffield Teaching Hospitals NHS Trust

    Sheffield

Other trials in United Kingdom

About this study

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

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.

Read the 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).

Being tested
Alemtuzumab, Basiliximab, Sirolimus, Tacrolimus
Keywords
Kidney transplantation, Alemtuzumab, Sirolimus, Basiliximab, Tacrolimus, Campath-1H

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlemtuzumabDrug

    Also called Campath-1H

    Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart

  • BasiliximabDrug

    Also called Simulect

    20 mg intravenously, two doses 96 hours apart

  • SirolimusDrug

    Also called Rapamune

    Sirolimus: target trough levels 6-12 ng/mL for first 6-months after maintenance therapy randomization, then 5-10 ng/mL

  • TacrolimusDrug

    Also called Prograf

    Tacrolimus: target trough levels 5-7 ng/mL after maintenance therapy randomization.

Study groups in NCT01120028
Study groupRoleWhat they receive
Alemtuzumab/SirolimusExperimentalInduction therapy allocation: Alemtuzumab (Campath-1H). Maintenance therapy allocation (at 6-months post-transplant): Sirolimus
Receives: Drug: Alemtuzumab; Drug: Sirolimus
Alemtuzumab/TacrolimusExperimentalInduction therapy allocation: Alemtuzumab (Campath-1H). Maintenance therapy allocation (at 6-months post-transplant): Tacrolimus
Receives: Drug: Alemtuzumab; Drug: Tacrolimus
Basiliximab/TacrolimusActive comparatorInduction therapy allocation: Basiliximab. Maintenance therapy allocation (at 6-months post-transplant): Tacrolimus
Receives: Drug: Basiliximab; Drug: Tacrolimus
Basiliximab/SirolimusActive comparatorInduction therapy allocation: Basiliximab. Maintenance therapy allocation (at 6-months post-transplant): Sirolimus
Receives: Drug: Basiliximab; Drug: Sirolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Biopsy-proven Acute Rejection at 6-months After Randomization to Induction Therapy

    Occurence of biopsy-proven acute rejection events at 6-months after transplantation during Period 1 (randomization to induction therapy (Campath-1H and Tacrolimus, or Basiliximab and Tacrolimus))

    Measured: 6 months post-transplantation

  2. Graft Function (at 18-months After Randomization to Maintenance Therapy)

    Estimated glomerular filtration rate (estimated using MDRD formula) at 18-months after maintenance therapy randomization to either Sirolimus or Tacrolimus.

    Measured: 2 years post-transplantation

Secondary outcomes (6)

  1. Number of Participants With Graft Failure (at 6-months After Randomization to Induction Therapy)

    Return to dialysis or re-transplantation by 6-months after randomization to induction therapy.

    Measured: 6 months post-transplantation

  2. Number of Participants With Graft Failure (at 18-Months After Randomization to Maintenance Therapy)

    Return to dialysis or re-transplantation by 18-months after randomization to maintenance therapy.

    Measured: 2 years post-transplantation

  3. Number of Participants With Serious Infection (at 6-months After Randomization to Induction Therapy)

    Occurrence of any serious infection (opportunistic or requiring admission to hospital) reported within Period 1 (randomization to induction therapy of either Alemtuzumab (Campath-1H) and Tacrolimus, or Basiliximab and Tacrolimus).

    Measured: 6-months post-transplantation

  4. Number of Participants With Serious Infection (at 18-months After Randomization to Maintenance Therapy)

    Occurrence of any serious infection (opportunistic or requiring admission to hospital) reported during Period 2 (maintenance therapy randomization to either Sirolimus or Tacrolimus).

    Measured: 2 years post-transplantation

  5. Number of Participants With Cancer (at 18-months After Randomization to Maintenance Therapy)

    Occurrence of any cancer reported during Period 2 (maintenance therapy randomization to either Sirolimus or Tacrolimus).

    Measured: 2 years post-transplantation

  6. Number of Participants With Major Vascular Event (at 18-months After Randomization to Maintenance Therapy)

    Composite of non-fatal myocardial infarction, non-fatal stroke, cardiovascular death or arterial revascularization

    Measured: 2 years post-transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionFeb 2014
  4. Study completionMar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
852 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01120028
Sponsor's protocol ID
CTSU3C1
Other IDs
2008-008553-27, ISRCTN88894088, 2008
Acronym
3C
Status last verified
Mar 2020
First submitted
6 May 2010
Last updated
2 Apr 2020
Data monitoring committee
Yes
Individual data sharing
Yes: Proposals for substudies must be approved by the Steering Committee. Procedure for accessing the data for this study are available on https://www.ndph.ox.ac.uk/data-access

Publications

  • 3C Study Collaborative Group; Haynes R, Harden P, Judge P, Blackwell L, Emberson J, Landray MJ, Baigent C, Friend PJ. Alemtuzumab-based induction treatment versus basiliximab-based induction treatment in kidney transplantation (the 3C Study): a randomised trial. Lancet. 2014 Nov 8;384(9955):1684-90. doi: 10.1016/S0140-6736(14)61095-3. Epub 2014 Jul 28.

    PubMed 25078310

  • 3C Study Collaborative Group. Campath, calcineurin inhibitor reduction, and chronic allograft nephropathy (the 3C Study) - results of a randomized controlled clinical trial. Am J Transplant. 2018 Jun;18(6):1424-1434. doi: 10.1111/ajt.14619. Epub 2018 Jan 9.

    PubMed 29226570

  • Haynes R, Baigent C, Harden P, Landray M, Akyol M, Asderakis A, Baxter A, Bhandari S, Chowdhury P, Clancy M, Emberson J, Gibbs P, Hammad A, Herrington W, Jayne K, Jones G, Krishnan N, Lay M, Lewis D, Macdougall I, Nathan C, Neuberger J, Newstead C, Pararajasingam R, Puliatti C, Rigg K, Rowe P, Sharif A, Sheerin N, Sinha S, Watson C, Friend P; 3C Study Collaborative Group. Campath, calcineurin inhibitor reduction and chronic allograft nephropathy (3C) study: background, rationale, and study protocol. Transplant Res. 2013 May 6;2(1):7. doi: 10.1186/2047-1440-2-7.

    PubMed 23641902

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Alemtuzumab, Basiliximab and Sirolimus in people with Kidney Transplantation, run by University of Oxford at 20 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Biopsy-proven Acute Rejection at 6-months After Randomization to Induction Therapy (time frame: 6 months post-transplantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01120028, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.

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