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Guidelines for Tacrolimus use in Indian Kidney Transplant Patients
48
Indian Journal of Transplantation
MMF vs. no MMF, basic disease, and HLA mismatch, in that sequence. For matching of each variable, other than that variable all other field were hidden in computer excel sheet. Likewise all the variables were matched to best possible match and then the data were analyzed. Since 1972 till March 2007 we did 1220 RT. IL2Rab was first time used in May 2002. Since then we have used IL2Rab in 60 patients (Group-A). One cadaver RT and 8 second RT were excluded. Of the 51 remaining patients, Basilaximab was used in 19 and Daclizumab in 32. We had 51 controls (Group-B). There was no difference in % males, hepatitis B and C infection, MMF and Tacrolimus use, donor age and mean follow-up in two groups. Mean age was more in Gr-A (40. 3 vs. 34. 7 yrs). Diabetes as basic disease was 25% and 11. 4% in Gr-A and Gr-B. HLA mismatch > 3 were 33. 4% and 11. 4% in Gr-a and Gr-B. Mean number of blood transfusions was less in GrA (1. 5 Vs. 3. 8). Current PRA > 20% was 10% in Gr-A and 4% in Gr-B. Mean GFR of donor was more in Gr-A ( 91. 3 vs. 83. 9 ml/mt). Acute rejection (AR), AR within 3 months, repeat AR were 7. 8%, 7. 8% and 3. 9% in Gr-A and 3. 9%, 3. 9% and 3. 95 in Gr-B (p=0. 4). Mean creatinine in Gr-A was 1. 6 mg% as compared to 1. 4 mg% in Gr-B. Serious infections, CMV, invasive fungal infection and PCP infection were similar in both the groups. Multivariate analysis using diabetes as basic disease, PRA>20% and HLS mismatch 3 showed no difference in AR in two groups. There was no difference in two groups in term of patient survival, graft survival and death censored graft survival.
Conclusion : Our results show that there is no benefit of IL2Rab induction in primary living related renal transplantation in term of acute rejection, repeat acute rejection, patient and graft survival.
Guidelines for Tacrolimus use in Indian Kidney Transplant Patients Ramalingam K. S, Thirumalaisamy. P, Gurumoorthi. P Jansi Ramalingam, Subha. R. , Devaki U
Indian J Transplant 2008; 2: 32-50
occurrence and comment on usefulness of drug levels.
Methods : 260 consecutive recipients of living donor renal allografts given Tacrolimus / Mycophenolate / Steroid regimen. Dosage adjusted using trough level estimation (< 6000 estimations - MEIA II Assay). Graft dysfunction evaluated by biopsy. Follow up data collected from August 2004 to August 2007 (minimum 4 weeks). Levels maintained around 10ng/ml (30 days) 7. 5-10ng/ml (0-6 months); around 7. 5ng/ml (6-12 months).
Results : Required tacrolimus dose at initiation, 0. 140mg/kg/day. Maintenance 0-3 months 0. 101 mg/kg/day (average creatinine 0. 9) 3-6 months 0. 087 (average creatinine 1. 2) 6-12 months 0. 080 mg/kg/day (average creatinine 1. 2) 25. 2% of patients required dose <0. 075mg/kg/day. 10. 4 % patients required only 0. 020mg/kg/day. 3. 31% of patients required 0. 013mg/kg/day. 1st month level done average 7 times; 40 % useful for dose change. 9. 4 % Acute tacrolimus toxicity; acute toxicity more (67%) in 1st month.
Conclusion : Tacrolimus dosage needed in Indian patients initial 0. 14mg/kg/day. 0-3 months 0. 101; 6-12 months 0. 087; 612 months 0. 080. Low dose <0. 075mg/kg/day sufficient during maintenance in 25% of patients. 10. 4% of patients required only 0. 020mg/kg/day. 3. 3% of patients required only 0. 013mg/kg/day. Level estimation very useful; frequency can be reduced. Acute toxicity occurs mostly during 1st month.
Is induction really needed in unrelated Renal Transplant ? K Mahesh Prasad Introduction :
Introduction :
Our Renal transplant program started on may 2004 with the aim of making it affordable without compromising on safety and quality of patient’s life. Driven by numerous published national and international data we formulated our own regimen to provide low cost Renal Transplant.
Tacrolimus is used in India for the last three years as immunosuppression for Kidney Transplantation. There are not many large experience reports on its use from India. Tacrolimus doses needed, trough levels and toxicity in Indian patients have not been reported.
Our immuno–suppression regimen does not include induction with Polyclonal or Monoclonal Antibody in any case, be it a related, unrelated or cadaver transplant. We use minimum doses of Tacrolimus with early tapering of Steroid.
We report our large experience with Tacrolimus and suggest guidelines for its use. Our aims are to report dose of tacrolimus used stressing on the low dose required, frequency of tacrolimus toxicity, its time of
Objective :
Coimbatore Kidney Centre, Coimbatore
Copyright © 2008 by The Indian Society of Organ Transplantation
To analyze the outcome of unrelated ( live & cadaver ) transplant without Induction with monoclonal antibody.
Indian Journal of Transplantation
MMF vs. no MMF, basic disease, and HLA mismatch, in that sequence. For matching of each variable, other than that variable all other field were hidden in computer excel sheet. Likewise all the variables were matched to best possible match and then the data were analyzed. Since 1972 till March 2007 we did 1220 RT. IL2Rab was first time used in May 2002. Since then we have used IL2Rab in 60 patients (Group-A). One cadaver RT and 8 second RT were excluded. Of the 51 remaining patients, Basilaximab was used in 19 and Daclizumab in 32. We had 51 controls (Group-B). There was no difference in % males, hepatitis B and C infection, MMF and Tacrolimus use, donor age and mean follow-up in two groups. Mean age was more in Gr-A (40. 3 vs. 34. 7 yrs). Diabetes as basic disease was 25% and 11. 4% in Gr-A and Gr-B. HLA mismatch > 3 were 33. 4% and 11. 4% in Gr-a and Gr-B. Mean number of blood transfusions was less in GrA (1. 5 Vs. 3. 8). Current PRA > 20% was 10% in Gr-A and 4% in Gr-B. Mean GFR of donor was more in Gr-A ( 91. 3 vs. 83. 9 ml/mt). Acute rejection (AR), AR within 3 months, repeat AR were 7. 8%, 7. 8% and 3. 9% in Gr-A and 3. 9%, 3. 9% and 3. 95 in Gr-B (p=0. 4). Mean creatinine in Gr-A was 1. 6 mg% as compared to 1. 4 mg% in Gr-B. Serious infections, CMV, invasive fungal infection and PCP infection were similar in both the groups. Multivariate analysis using diabetes as basic disease, PRA>20% and HLS mismatch 3 showed no difference in AR in two groups. There was no difference in two groups in term of patient survival, graft survival and death censored graft survival.
Conclusion : Our results show that there is no benefit of IL2Rab induction in primary living related renal transplantation in term of acute rejection, repeat acute rejection, patient and graft survival.
Guidelines for Tacrolimus use in Indian Kidney Transplant Patients Ramalingam K. S, Thirumalaisamy. P, Gurumoorthi. P Jansi Ramalingam, Subha. R. , Devaki U
Indian J Transplant 2008; 2: 32-50
occurrence and comment on usefulness of drug levels.
Methods : 260 consecutive recipients of living donor renal allografts given Tacrolimus / Mycophenolate / Steroid regimen. Dosage adjusted using trough level estimation (< 6000 estimations - MEIA II Assay). Graft dysfunction evaluated by biopsy. Follow up data collected from August 2004 to August 2007 (minimum 4 weeks). Levels maintained around 10ng/ml (30 days) 7. 5-10ng/ml (0-6 months); around 7. 5ng/ml (6-12 months).
Results : Required tacrolimus dose at initiation, 0. 140mg/kg/day. Maintenance 0-3 months 0. 101 mg/kg/day (average creatinine 0. 9) 3-6 months 0. 087 (average creatinine 1. 2) 6-12 months 0. 080 mg/kg/day (average creatinine 1. 2) 25. 2% of patients required dose <0. 075mg/kg/day. 10. 4 % patients required only 0. 020mg/kg/day. 3. 31% of patients required 0. 013mg/kg/day. 1st month level done average 7 times; 40 % useful for dose change. 9. 4 % Acute tacrolimus toxicity; acute toxicity more (67%) in 1st month.
Conclusion : Tacrolimus dosage needed in Indian patients initial 0. 14mg/kg/day. 0-3 months 0. 101; 6-12 months 0. 087; 612 months 0. 080. Low dose <0. 075mg/kg/day sufficient during maintenance in 25% of patients. 10. 4% of patients required only 0. 020mg/kg/day. 3. 3% of patients required only 0. 013mg/kg/day. Level estimation very useful; frequency can be reduced. Acute toxicity occurs mostly during 1st month.
Is induction really needed in unrelated Renal Transplant ? K Mahesh Prasad Introduction :
Introduction :
Our Renal transplant program started on may 2004 with the aim of making it affordable without compromising on safety and quality of patient’s life. Driven by numerous published national and international data we formulated our own regimen to provide low cost Renal Transplant.
Tacrolimus is used in India for the last three years as immunosuppression for Kidney Transplantation. There are not many large experience reports on its use from India. Tacrolimus doses needed, trough levels and toxicity in Indian patients have not been reported.
Our immuno–suppression regimen does not include induction with Polyclonal or Monoclonal Antibody in any case, be it a related, unrelated or cadaver transplant. We use minimum doses of Tacrolimus with early tapering of Steroid.
We report our large experience with Tacrolimus and suggest guidelines for its use. Our aims are to report dose of tacrolimus used stressing on the low dose required, frequency of tacrolimus toxicity, its time of
Objective :
Coimbatore Kidney Centre, Coimbatore
Copyright © 2008 by The Indian Society of Organ Transplantation
To analyze the outcome of unrelated ( live & cadaver ) transplant without Induction with monoclonal antibody.