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Impact of cyclosporine reduction with MMF: a randomized trial in chronic allograft dysfunction. The 'reference' study
L Frimat1, E Cassuto-Viguier, B Charpentier
1Service de Néphrologie/Transplantation, Nancy-Université, France.
Abstract:
Long-term use of calcineurine inhibitors (CNIs) may contribute to the development of chronic allograft dysfunction (CAD). We investigate the impact of the introduction of MMF combined with cyclosporine (CsA) 50% dose reduction. An open, randomized, controlled, multicenter, prospective study was conducted in 103 patients, receiving a CsA-based therapy with a serum creatinine between 1.7-3.4 mg/dL, more than 1 year after transplantation. They were randomized to receive MMF with half dose of CsA (MMF group) or to continue their maintenance CsA dose (control group). A total of 96 weeks after randomization, the evolution of renal function assessed by regression line analysis of 1/SeCr improved in the MMF group (positive slope) vs. the control group (negative slope), 4.2 x 10(-4) vs. -3.0 x 10(-4), respectively (p < 0.001). Concurrently, the absolute renal function improved significantly in the MMF group. No episode of biopsy-proven acute rejection occurred. One patient in each group lost his graft because of biopsy-proven chronic allograft nephropathy. There was a significant decrease of triglycerides level in the MMF group. Anemia and diarrhea were statistically more frequent in the MMF group. In CAD, the reduction of CsA in the presence of MMF results in significant improvement in renal function during a 2-year follow-up.
Insights
Reducing cyclosporine (CsA) dosage with mycophenolate mofetil (MMF) improves renal function in patients with chronic allograft dysfunction (CAD). This strategy offers a significant benefit for long-term transplant outcomes.
Area of Science:
- Nephrology
- Immunology
- Transplantation Medicine
Background:
- Long-term calcineurin inhibitor (CNI) use is linked to chronic allograft dysfunction (CAD).
- Maintaining immunosuppression while mitigating CNI toxicity is crucial for graft survival.
Purpose of the Study:
- To evaluate the efficacy of reducing cyclosporine (CsA) dosage by 50% and introducing mycophenolate mofetil (MMF) in patients with established CAD.
- To assess the impact on renal function and graft outcomes.
Main Methods:
- An open-label, randomized, controlled, multicenter, prospective study.
- 103 post-transplant patients with serum creatinine 1.7-3.4 mg/dL were randomized.
- Intervention group received MMF with reduced CsA; control group continued maintenance CsA.
Main Results:
- Renal function significantly improved in the MMF group (slope 4.2 x 10(-4)) compared to the control group (slope -3.0 x 10(-4)) over 96 weeks (p < 0.001).
- No biopsy-proven acute rejection occurred; one graft loss due to chronic allograft nephropathy in each group.
- Triglyceride levels decreased significantly in the MMF group; anemia and diarrhea were more frequent.
Conclusions:
- Reducing CsA dosage in combination with MMF significantly improves renal function in patients with chronic allograft dysfunction.
- This therapeutic approach demonstrates a positive impact on long-term renal function in kidney transplant recipients with CAD.