Health Condition 1: null- Renal transplant
Conditions
Interventions
None listed
Sponsors
Seth GS Medical College and KEM Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Renal allograft recipients on tacrolimus therapy [for at least three months] attending transplant clinic Willing to give written, informed consent
Exclusion criteria
Exclusion criteria: Subjects requiring tacrolimus dose adjustment of tacrolimus for reasons other than optimum C 0 levels. (eg BK Virus Cytomegalovirus Infection) Patients requiring cessation of tacrolimus therapy due to primary graft non-function graft nephrectomy ABO incompatible transplant Patient with positive Donor Specific Antibodies with or without desensitization and panel reactive antibody > 50% Patients >60 years with cognitive impairment (as assessed by a neurologist) will be excluded from the study Patients [deemed by the investigator] to have data on records incomplete to fulfil the study objectives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tacrolimus trough levels at Day 7 30 60 90 post transplants Number of dose modifications required to achieve the target C0 in immediate post transplant period Graft function at day 10 30 90 and at last follow-up Number of acute rejections requiring anti rejection therapy (clinically diagnosed) Number of acute biopsy proven rejections Incidence of new onset proteinuria Incidence of chronic allograft dysfunction Incidence of chronic allograft rejection Timepoint: Tacrolimus trough levels at Day 7 30 60 90 post transplants Number of dose modifications required to achieve the target C0 in immediate post transplant period Graft function at day 10 30 90 and at last follow-up Number of acute rejections requiring anti rejection therapy (clinically diagnosed) Number of acute biopsy proven rejections Incidence of new onset proteinuria Incidence of chronic allograft dysfunction Incidence of chronic allograft rejection | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of dose modifications required to achieve the target C0 in immediate post transplant period Graft function at day 10 30 90 and at last follow-up Number of acute rejections requiring anti rejection therapy (clinically diagnosed) Number of acute biopsy proven rejections Incidence of new onset proteinuria Incidence of chronic allograft dysfunction Incidence of chronic allograft rejectionTimepoint: 1 year | — |
Countries
India
Contacts
Public ContactMiteshkumar Maurya
Department of Nephrology Seth GS Medical College and KEM Hospital
Outcome results
None listed