Early Switch From Cyclosporine To Sirolimus After Renal Transplantation Produces Sustained Improvement In Renal Function

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Main Category: Urology / Nephrology
Also Included In: Transplants / Organ Donations;  Immune System / Vaccines
Article Date: 18 Jun 2009 - 6:00 PDT

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BOSTON - Favorable 12-month outcomes are maintained through 30 months of follow-up when renal transplant patients are converted from a cyclosporine (CsA)-based regimen to a sirolimus (SRL)-based regimen three months post-transplant, according to results of the CONCEPT study announced here at the American Transplant Congress (ATC) 2009.

Yvon Lebranchu, MD, from the University François Rabelais in Tours, France, reported 30-month results in patients who were initially treated with mycophenolate mofetil (MMF) plus cyclosporine (CsA) and then randomized three months later to continue this regimen, or CsA therapy was stopped and replaced by SRL. The trial included 192 first-time renal allograft recipients at 16 centers throughout France.

"Long term use of CsA may contribute to the development of chronic allograft nephropathy," Dr. Lebranchu pointed out. "While earlier trials have demonstrated a positive impact of de novo SRL on renal function at one year post transplantation, adverse effects have limited the use of this approach."

An analysis at 12 months in 181 patients found that glomerular filtration rate (GFR), as estimated by the simplified MDRD formula, was significantly better in the SRL group (61.9 mL/min versus 53.8 mL/min, p=0.0002). Improvement in renal function occurred without a significant increase in acute rejection.

Thirty-month results in 152 patients in the intent-to-treat population showed an MDRD GFR of 58.3 mL/min and 52.6 mL/min in the two groups, respectively, p=0.027. This difference was more pronounced in patients on treatment: 64.4 mL/min and 53.8 mL/min in the two groups, respectively.

Graft loss and patient survival were similar in the two treatment groups.

One patient in the SRL/MMF group had developed a malignancy versus six patients in the CsA group.

"Long-term maintenance of renal function is a challenge in renal transplant recipients, and the use of CNIs is associated with chronic long-term graft dysfunction," Dr. Lebranchu said. "The identification of strategies of CNI avoidance or elimination is extremely important."

Sandi See Tai, MD, Director, Global Medical Affairs, Transplantation, Wyeth Pharmaceuticals, said that the data are encouraging "because they indicate better long-term outcomes for kidney transplant patients." Wyeth Pharmaceuticals markets sirolimus under the trade name RAPAMUNE®.

"Overall, the interim results of CONCEPT show that a sirolimus-based regimen may provide lasting benefits in renal transplant patients," Dr. Lebranchu added.

Written by Jill Stein
Jill Stein is a Paris-based freelance medical writer.
jillstein03(at)gmail.com


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