Tacrolimus-Based, Steroid-Free Regimens in Renal Transplantation: 3-Year Follow-up of the ATLAS Trial.
Kramer BK, Klinger M, et al.Transplantation, 94(5):492-498, 2012.
Aims
To compare the long-term efficacy and safety of two steroid-free regimens with a standard tacrolimus-based triple immunosuppressive therapy in renal transplant recipients.
Interventions
Tacrolimus monotherapy plus basiliximab induction therapy versus tacrolimus plus mycophenolate mofetil (MMF) or tacrolimus plus MMF and steroids.
Participants
421 renal transplant recipients.
Outcomes
The efficacy endpoints were incidences of biopsy proven acute rejection, patient and graft survival, renal function measured by serum creatinine levels and calculated glomerular filtration rates. Safety assessment included adverse events, blood pressure, use of antihypertensives, new-onset diabetes mellitus or use of insulin, changes in laboratory parameters including serum lipids, haemoglobin, white blood count, platelet count and vital signs.
Follow-up
3 years
CET Conclusions
Results of the ATLAS study at 3 year follow up are reported (6 month follow up previously reported). Three different immune-suppression regimens were compared: Basiliximab/Tacrolimus, Basiliximab/Tacrolimus/MMF and Tacrolimus/MMF/Steroids. The number of episodes of biopsy proven acute rejection between 6 months and 3 years was no different between the groups. Graft survival and patient survival were comparable across groups for the whole of the follow up period. Renal function was comparable throughout the study also. The Basiliximab/Tacrolimus group experienced a greater reduction in serum low-density lipoprotein after transplantation than the other groups. There were no differences in blood pressure parameters, use of antihypertensives, new-onset diabetes mellitus or use of insulin. Thus in low risk recipients a steroid free regimen appears to be acceptable.
Data analysis
Strict intention-to-treat analysis
Quality notes
This paper reported the same trial of the publication: Vitko S, Klinger M, Salmela K, et al. Two corticosteroid-free regimens — tacrolimus monotherapy after basiliximab administration and tacrolimus/mycophenolate mofetil — in comparison with a standard triple regimen in renal transplantation: results of the ATLAS study. Transplantation, 2005; 80: 1734. The methodological quality assessment was based on the article by Vitko et al.
Trial registration
CRG020800135 (Cochrane Renal Group)