Health Condition 1: N186- End stage renal disease
Conditions
Interventions
Intervention1: Prolonged Release Tacrolimus: Long acting formulation of Tacrolimus for 45 days post transplantation
Control Intervention1: Immediate Release Tacrolimus: Short Acting Formulation of Tac
Sponsors
PGIMER Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: . Patients of age 18-55 years who are undergoing renal transplant. 2. Participants willing to provide written informed consent. 3. Able to adhere to the study visit schedule and other protocol requirements. 4. All subjects must agree not to share medication. 5. Subject (male or female) is willing to use highly effective methods during the study treatment (adequate: combined hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence).
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants with deranged Oral Glucose Tolerance Test (OGTT) after 45 days of transplantation between Prolonged release versus Immediate release tacrolimus group.Timepoint: The proportion of participants with deranged Oral Glucose Tolerance Test (OGTT) at baseline and after 6 weeks of transplantation between Prolonged release versus Immediate release tacrolimus group. | — |
Secondary
| Measure | Time frame |
|---|---|
| ? To compare the exposure to tacrolimus in one dosing interval (AUC 0-24) and (AUC 0-12) at one-month post-transplantation in the Prolonged release tacrolimus versus Immediate release group respectively. ? To compare the change in fasting plasma lipids and biomarkers (Fasting insulin, OGTT insulin, C-peptide, proinsulin, proinsulin/C-peptide, proinsulin/insulin ratio) pre-transplant period to the post-transplant period (45 days). ? To compare the acute rejection rate, and graft outcome (eGFR & urinary albumin) between Prolonged release tacrolimus versus immediate release tacrolimus group. ? Retrospective analysis of the genotype and its influence in metabolism. Timepoint: 30 days post transplant 3 months post transplant 6 months post transplant | — |
Countries
India
Contacts
Public ContactDr Smita Pattanaik
PGIMER Chandigarh
Outcome results
None listed