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Campath, calcineurin inhibitor reduction and chronic allograft nephropathy (3C) study: background, rationale, and
Richard Haynes1, Colin Baigent, Paul Harden
1Clinical Trial Service Unit & Epidemiological Studies Unit, Richard Doll Building, Old Road Campus, Roosevelt Drive, Headington Oxford OX3 7LF, UK. richard.haynes@ctsu.ox.ac.uk.
Background:
Kidney transplantation is the best treatment for patients with end-stage renal failure, but uncertainty remains about the best immunosuppression strategy. Long-term graft survival has not improved substantially, and one possible explanation is calcineurin inhibitor (CNI) nephrotoxicity. CNI exposure could be minimized by using more potent induction therapy or alternative maintenance therapy to remove CNIs completely. However, the safety and efficacy of such strategies are unknown.
Methods/Design:
The Campath, Calcineurin inhibitor reduction and Chronic allograft nephropathy (3C) Study is a multicentre, open-label, randomized controlled trial with 852 participants which is addressing two important questions in kidney transplantation. The first question is whether a Campath (alemtuzumab)-based induction therapy strategy is superior to basiliximab-based therapy, and the second is whether, from 6 months after transplantation, a sirolimus-based maintenance therapy strategy is superior to tacrolimus-based therapy. Recruitment is complete, and follow-up will continue for around 5 years post-transplant. The primary endpoint for the induction therapy comparison is biopsy-proven acute rejection by 6 months, and the primary endpoint for the maintenance therapy comparison is change in estimated glomerular filtration rate from baseline to 2 years after transplantation. The study is sponsored by the University of Oxford and endorsed by the British Transplantation Society, and 18 centers for adult kidney transplant are participating.
Discussion:
Late graft failure is a major issue for kidney-transplant recipients. If our hypothesis that minimizing CNI exposure with Campath-based induction therapy and/or an elective conversion to sirolimus-based maintenance therapy can improve long-term graft function and survival is correct, then patients should experience better graft function for longer. A positive outcome could change clinical practice in kidney transplantation.
Trial Registration:
ClinicalTrials.gov, NCT01120028 and ISRCTN88894088.
Insights
This study investigates if reducing calcineurin inhibitor (CNI) exposure through Campath induction or sirolimus maintenance improves kidney transplant outcomes. Findings could alter current immunosuppression strategies for better long-term graft survival.
Area of Science:
- Nephrology
- Transplantation immunology
- Clinical trials
Background:
- Kidney transplantation is optimal for end-stage renal failure, but long-term graft survival needs improvement.
- Calcineurin inhibitor (CNI) nephrotoxicity is a potential cause for suboptimal graft survival.
- Minimizing CNI exposure via potent induction or alternative maintenance therapy requires safety and efficacy evaluation.
Purpose of the Study:
- To compare Campath (alemtuzumab)-based induction therapy versus basiliximab-based therapy.
- To evaluate sirolimus-based maintenance therapy versus tacrolimus-based therapy for CNI reduction.
- To assess the impact of these strategies on long-term kidney graft function and survival.
Main Methods:
- A multicentre, open-label, randomized controlled trial (3C Study) involving 852 participants.
- Primary endpoint for induction: biopsy-proven acute rejection by 6 months.
- Primary endpoint for maintenance: change in estimated glomerular filtration rate (eGFR) from baseline to 2 years.
Main Results:
- Recruitment is complete, with approximately 5 years of follow-up planned.
- Data analysis will determine the efficacy of Campath induction and sirolimus maintenance.
- Results will indicate if reduced CNI exposure improves graft function and survival.
Conclusions:
- Late graft failure remains a significant challenge in kidney transplantation.
- This study hypothesizes that minimizing CNI exposure can enhance long-term graft function and survival.
- Positive findings could lead to a paradigm shift in kidney transplant immunosuppression protocols.
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