Tuesday, May 4, 2010

Does CAPRIT trial need a TREAT!!!!!

This morning at ATC, the results of a very interesting trial were presented. I would like to share them with you so we can look at them more carefully once the paper is published. The CAPRIT trial is the first randomized trial in kidney transplant recipients to evaluate the impact of complete normalization of anemia on the progression of the allograft function. Another anemia study!!!

It is a European multicentral trial of 126 patients who received kidney transplants more than 12 months before enrollment with CrCL between 20 and 50 and Hg level less than 11.5 mg/dL. Patients were randomized to either high Hg level group A with target Hg of 13-15 or to the low Hg level group B with Hg goal of 10.5-11.5 and were treated accordingly with ESA to achieve goal. Patients’ characteristics were similar, mainly the age at inclusion, age at transplant and mean GFR (34 and 33). Number of patients on ACEI/ARBs was similar in the two groups, both at the start of the study and at 2 years (the end of the study). Patients with Rapamune were excluded and all patients were on CNI and MMF with or without prednisone. 89% of the patients in group A were treated with EPO v.s 61 % in the lower Hg group with obviously higher dose in the higher Hg group.

There was a significantly higher mean GFR in the high Hg level group compared to low Hg level group and an increase rate of graft survival at 2 years with no difference in adverse events including cardiovascular events, stroke or thrombosis events. How to look at this data few months after the TREAT trial results were reported?

Although we are looking at different population of patients in the two trials but I find it difficult to believe this data in view of all the evidence that higher Hg is harmful, and we probably should wait for larger trial before we change our practice.

1 comment:

Joel Topf said...

I would be careful on how you characterize TREAT. I would not say that a careful analysis shows that the higher hemoglobins were harmful. The data seems to point more toward the ESA rather than the hemoglobin.