Campath, Calcineurin Inhibitor Reduction and Chronic Allograft Nephropathy
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.
Timeline
- Start
- 2010-09
- Primary completion
- 2014-02
- Completion
- 2020-03
Outcome
Mixed primary results
paper Overall, individuals allocated to alemtuzumab-based treatment had a 58% proportional reduction in biopsy-proven acute rejection compared with those allocated to basiliximab-based treatment PMID 25078310 ↗
registry Period 1: Alemtuzumab/Tacrolimus vs Period 1: Basiliximab/Tacrolimus; p <0.0001; Hazard Ratio (HR) 0.42 (95% CI 0.28 to 0.64); Log Rank NCT01120028 ↗
paper Allocation to sirolimus had no significant effect on eGFR at 18 months PMID 29226570 ↗
Publications
- Results 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.
- Results 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alemtuzumab | Monoclonal antibody | 30 mg | Intravenous |
| Comparator | Basiliximab | Monoclonal antibody | 20 mg | Intravenous |
| Subject | Sirolimus | Small molecule | — | — |
| Subject | Tacrolimus | Small molecule | — | — |
Indications
No indication recorded.