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Campath, Calcineurin Inhibitor Reduction and Chronic Allograft Nephropathy

NCT01120028 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 852

Last updated 2020-04-02

Study results available
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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.

Conditions

  • Kidney Transplantation

Interventions

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.

Sponsors & Collaborators

  • National Health Service, United Kingdom

    collaborator OTHER_GOV

  • Pfizer

    collaborator INDUSTRY

  • Novartis

    collaborator INDUSTRY

  • University of Oxford

    lead OTHER

Principal Investigators

  • Peter Friend · University of Oxford

  • Colin Baigent · University of Oxford

  • Martin J Landray · University of Oxford

  • Paul Harden · University of Oxford

  • Richard Haynes · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2014-02-28
Completion
2020-03-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01120028 on ClinicalTrials.gov