SAT-339 Low Dose Induction Immunotherapy with Anti Human T-lymphocyte Immunoglobulin (Grafalon) in High Risk Renal transplantation – A Real-world, Single Centre Experience from India

Abstract

The current armamentarium of rabbit polyclonals includes thymoglobulin and Grafalon. The experience with the latter has been quite limited as until recently it was not available in India. In addition, its dose and duration are controversial, differs center-wise, and is based on scarce clinical data. The objective of this study was to assess the safety and efficacy of Grafalon induction in live related high-risk kidney transplant patients. (history of blood transfusions, HLA mismatch> 3). This was a single-center, prospective, observational study of 54 renal transplant patients who received Grafalon as induction therapy. All patients underwent living donor kidney transplantation. Pre-transplant CDC and flow crossmatch were negative in all. Grafalon was administered at an average dose of 6.0 mg/kg body weight, as a single dose infusion through peripheral intravenous line over 3 hours on day 0. Tacrolimus, MMF and prednisolone constituted maintenance immunosuppression in all patients. These patients were followed up twice a week for 1 month, once a week for 2nd month and once in 15 days for the 3rd month and thereafter once a month. At each visit, they were evaluated clinically as well subjected to laboratory investigations. Tacrolimus levels were monitored twice a week for the first week, once a week for the first month and thereafter once a month. Microsoft Excel was used to analyse the data. All of the patients tolerated Grafalon infusion well and there were no major infusion reactions or fever requiring temporary stoppage or cessation of the drug. Seven patients (13%) developed biopsy proven acute rejection. Majority of them were mild grade cellular rejections and responded well to steroids with good recovery of renal function. At a mean follow up of 10.65+5.4months, patient survival was 100% and graft survival was 100%. Infection episodes were seen in 7 patients with UTI (n=6) being the commonest cause. There were no documented CMV or BK virus infections. Post-transplant, day 1 serum creatinine was 4.89+2.78 mg/dL which reduced to 1.44 ± 0.8mg/dL (n=49, p<0.0001) at day 10 and 1.24 ± 0.35 mg/dl (n=34, p<0.0001) at day 30. Grafalon (6mg/kg) is associated with an acceptable efficacy and safety profile in renal transplantation. Larger studies are necessary to confirm the findings.