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Long-Term Impact of Cyclosporin Reduction with MMF Treatment in Chronic Allograft Dysfunction: REFERENECE Study 3-Year Follow Up.

Frimat L, Cassuto-Viguier E, Provôt F, Rostaing L, Charpentier B, Akposso K, Moal MC, Lang P, Glotz D, Caillard S, Ducloux D, Pouteil-Noble C, Girardot-Seguin S, Kessler M - J Transplant (2010)

Bottom Line: There was no statistically significant difference in the occurrence of serious adverse events or acute graft rejections.A limitation is the weak proportion of patient still remaining within the control group.On the other hand, REFERENCE focuses on the CsA regimen while opinions about the tacrolimus ones are still debated.

View Article: PubMed Central - PubMed

Affiliation: Service de Néphrologie/Transplantation, CHU de Nancy, rue du Morvan, 54511 Vandoeuvre-Les-Nancy, France.

ABSTRACT
Calcineurin inhibitor (CNI) toxicity contributes to chronic allograft nephropathy (CAN). In the 2-year, randomized, study, we showed that 50% cyclosporin (CsA) reduction in combination with mycophenolate mofetil (MMF) treatment improves kidney function without increasing the risk for graft rejection/loss. To investigate the long-term effect of this regimen, we conducted a follow up study in 70 kidney transplant patients until 5 years after REFERENCE initiation. The improvement of kidney function was confirmed in the MMF group but not in the control group (CsA group). Four graft losses occurred, 2 in each group (graft survival in the MMF group 95.8% and 90.9% in control group). One death occurred in the control group. There was no statistically significant difference in the occurrence of serious adverse events or acute graft rejections. A limitation is the weak proportion of patient still remaining within the control group. On the other hand, REFERENCE focuses on the CsA regimen while opinions about the tacrolimus ones are still debated. In conclusion, CsA reduction in the presence of MMF treatment seems to maintain kidney function and is well tolerated in the long term.

No MeSH data available.


Related in: MedlinePlus

(a) Evolution of creatinine clearance over time in the randomization population (MMF group versus control group). (b) Evolution of creatinine clearance over time in the on-treatment population (group I versus group II). The vertical, dotted line separates initial study phase and follow up phase.
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fig4: (a) Evolution of creatinine clearance over time in the randomization population (MMF group versus control group). (b) Evolution of creatinine clearance over time in the on-treatment population (group I versus group II). The vertical, dotted line separates initial study phase and follow up phase.

Mentions: Creatinine clearance as presented in Figure 4(a) increased in the MMF group during the initial study period (47.3 mL/min ± 11.4 at baseline and 56.9 mL/min ± 16.7 at month 24) and gradually diminished during the post-trial period to 51.8 mL/min ± 20.2 at month 60. In the control group this parameter remained stable during the initial study phase (43.5 mL/min ± 12.0 at baseline and 44.2 mL/min ± 14.6 at month 24) and slightly decreased during the post-trial phase to 41.3 mL/min ± 18.9 at month 60. Analysis of group I showed a result similar to the MMF group (Figure 4(b)), while creatinine clearance in group II abruptly fell at month 54 and was 38.1 mL/min ± 22.1 at month 60 compared to 45.8 mL/min ± 16.4 at month 24. The differences observed between MMF and control group and group I and group II at the end of the study were not statistically significant (P = .066). Creatinine clearance changes between baseline and month 60 were not significantly different in any of the four groups nor were the changes for the same time period between the MMF group and the control group, and group I and group II.


Long-Term Impact of Cyclosporin Reduction with MMF Treatment in Chronic Allograft Dysfunction: REFERENECE Study 3-Year Follow Up.

Frimat L, Cassuto-Viguier E, Provôt F, Rostaing L, Charpentier B, Akposso K, Moal MC, Lang P, Glotz D, Caillard S, Ducloux D, Pouteil-Noble C, Girardot-Seguin S, Kessler M - J Transplant (2010)

(a) Evolution of creatinine clearance over time in the randomization population (MMF group versus control group). (b) Evolution of creatinine clearance over time in the on-treatment population (group I versus group II). The vertical, dotted line separates initial study phase and follow up phase.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2913628&req=5

fig4: (a) Evolution of creatinine clearance over time in the randomization population (MMF group versus control group). (b) Evolution of creatinine clearance over time in the on-treatment population (group I versus group II). The vertical, dotted line separates initial study phase and follow up phase.
Mentions: Creatinine clearance as presented in Figure 4(a) increased in the MMF group during the initial study period (47.3 mL/min ± 11.4 at baseline and 56.9 mL/min ± 16.7 at month 24) and gradually diminished during the post-trial period to 51.8 mL/min ± 20.2 at month 60. In the control group this parameter remained stable during the initial study phase (43.5 mL/min ± 12.0 at baseline and 44.2 mL/min ± 14.6 at month 24) and slightly decreased during the post-trial phase to 41.3 mL/min ± 18.9 at month 60. Analysis of group I showed a result similar to the MMF group (Figure 4(b)), while creatinine clearance in group II abruptly fell at month 54 and was 38.1 mL/min ± 22.1 at month 60 compared to 45.8 mL/min ± 16.4 at month 24. The differences observed between MMF and control group and group I and group II at the end of the study were not statistically significant (P = .066). Creatinine clearance changes between baseline and month 60 were not significantly different in any of the four groups nor were the changes for the same time period between the MMF group and the control group, and group I and group II.

Bottom Line: There was no statistically significant difference in the occurrence of serious adverse events or acute graft rejections.A limitation is the weak proportion of patient still remaining within the control group.On the other hand, REFERENCE focuses on the CsA regimen while opinions about the tacrolimus ones are still debated.

View Article: PubMed Central - PubMed

Affiliation: Service de Néphrologie/Transplantation, CHU de Nancy, rue du Morvan, 54511 Vandoeuvre-Les-Nancy, France.

ABSTRACT
Calcineurin inhibitor (CNI) toxicity contributes to chronic allograft nephropathy (CAN). In the 2-year, randomized, study, we showed that 50% cyclosporin (CsA) reduction in combination with mycophenolate mofetil (MMF) treatment improves kidney function without increasing the risk for graft rejection/loss. To investigate the long-term effect of this regimen, we conducted a follow up study in 70 kidney transplant patients until 5 years after REFERENCE initiation. The improvement of kidney function was confirmed in the MMF group but not in the control group (CsA group). Four graft losses occurred, 2 in each group (graft survival in the MMF group 95.8% and 90.9% in control group). One death occurred in the control group. There was no statistically significant difference in the occurrence of serious adverse events or acute graft rejections. A limitation is the weak proportion of patient still remaining within the control group. On the other hand, REFERENCE focuses on the CsA regimen while opinions about the tacrolimus ones are still debated. In conclusion, CsA reduction in the presence of MMF treatment seems to maintain kidney function and is well tolerated in the long term.

No MeSH data available.


Related in: MedlinePlus