NCT01120028

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
852

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2010

Longer than P75 for phase_2

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 10, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

October 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

April 2, 2020

Status Verified

March 1, 2020

Enrollment Period

3.4 years

First QC Date

May 6, 2010

Results QC Date

June 10, 2019

Last Update Submit

March 23, 2020

Conditions

Kidney Transplantation

Keywords

Kidney transplantationAlemtuzumabSirolimusBasiliximabTacrolimusCampath-1H

Outcome Measures

Primary Outcomes (2)

  • 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))

    6 months post-transplantation

  • 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.

    2 years post-transplantation

Secondary Outcomes (6)

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

    6 months post-transplantation

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

    2 years post-transplantation

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

    6-months post-transplantation

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

    2 years post-transplantation

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

    2 years post-transplantation

  • +1 more secondary outcomes

Study Arms (4)

Alemtuzumab/Sirolimus

EXPERIMENTAL

Induction therapy allocation: Alemtuzumab (Campath-1H). Maintenance therapy allocation (at 6-months post-transplant): Sirolimus

Drug: AlemtuzumabDrug: Sirolimus

Alemtuzumab/Tacrolimus

EXPERIMENTAL

Induction therapy allocation: Alemtuzumab (Campath-1H). Maintenance therapy allocation (at 6-months post-transplant): Tacrolimus

Drug: AlemtuzumabDrug: Tacrolimus

Basiliximab/Tacrolimus

ACTIVE COMPARATOR

Induction therapy allocation: Basiliximab. Maintenance therapy allocation (at 6-months post-transplant): Tacrolimus

Drug: BasiliximabDrug: Tacrolimus

Basiliximab/Sirolimus

ACTIVE COMPARATOR

Induction therapy allocation: Basiliximab. Maintenance therapy allocation (at 6-months post-transplant): Sirolimus

Drug: BasiliximabDrug: Sirolimus

Interventions

AlemtuzumabDRUG

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

Also known as: Campath-1H
Alemtuzumab/SirolimusAlemtuzumab/Tacrolimus
BasiliximabDRUG

20 mg intravenously, two doses 96 hours apart

Also known as: Simulect
Basiliximab/SirolimusBasiliximab/Tacrolimus
SirolimusDRUG

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

Also known as: Rapamune
Alemtuzumab/SirolimusBasiliximab/Sirolimus
TacrolimusDRUG

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

Also known as: Prograf
Alemtuzumab/TacrolimusBasiliximab/Tacrolimus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Oxford Radcliffe Hospitals NHS Trust

Oxford, Oxon, OX3 7LJ, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Location

Addenbrooke's Hospital NHS Trust

Cambridge, United Kingdom

Location

University Hospital of Wales

Cardiff, United Kingdom

Location

University Hospitals Coventry & Warwickshire

Coventry, United Kingdom

Location

Royal Infirmary

Edinburgh, United Kingdom

Location

Western Infirmary

Glasgow, United Kingdom

Location

Hull and East Yorkshire Hospitals NHS Trust

Hull, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Location

Royal Liverpool and Broadgreen University Hospitals NHS Trust

Liverpool, United Kingdom

Location

Bart's and the London NHS Trust

London, United Kingdom

Location

Guy's and St Thomas's NHS Trust

London, United Kingdom

Location

Kings College Hospital NHS Trust

London, United Kingdom

Location

Royal Free Hampstead NHS Trust

London, United Kingdom

Location

Central Manchester NHS Trust

Manchester, United Kingdom

Location

Newcastle-upon-Tyne Hospitals NHS Trust

Newcastle, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Location

Plymouth Teaching Hospitals NHS Trust

Plymouth, United Kingdom

Location

Portsmouth Hospitals NHS Trust

Portsmouth, United Kingdom

Location

Sheffield Teaching Hospitals NHS Trust

Sheffield, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 25078310RESULT

  • 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.

    PMID: 29226570RESULT

  • 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.

    PMID: 23641902DERIVED

Related Links

MeSH Terms

Interventions

AlemtuzumabBasiliximabSirolimusTacrolimus

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsMacrolidesLactonesOrganic Chemicals

Results Point of Contact

Title
Prof Peter Friend
Organization
University of Oxford
ccc@ctsu.ox.ac.uk
01865223872

Study Officials

  • Peter Friend

    University of Oxford

    STUDY DIRECTOR

  • Colin Baigent

    University of Oxford

    PRINCIPAL INVESTIGATOR

  • Martin J Landray

    University of Oxford

    PRINCIPAL INVESTIGATOR

  • Paul Harden

    University of Oxford

    PRINCIPAL INVESTIGATOR

  • Richard Haynes

    University of Oxford

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2010

First Posted

May 10, 2010

Study Start

September 1, 2010

Primary Completion

February 1, 2014

Study Completion

March 1, 2020

Last Updated

April 2, 2020

Results First Posted

October 1, 2019

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP
Access Criteria
See URL
More information

Locations

GB(20)