Health Condition 1: N185- Chronic kidney disease, stage 5
Conditions
Interventions
Intervention1: Piperine: Tacrolimus + MMF + Piperine 20 mg OD or BD
Control Intervention1: Tacrolimus + MMF: The participant will be his own control, Tacrolimus and MMF is the standard of care
Sponsors
Department of Health Research
Eligibility
Inclusion criteria
Inclusion criteria: Adult renal transplant patients after 1 week post transplantation period aged 18 to 65 years Those requiring more than 0.3 mg per kgs of tacrolimus Unable to attain therapeutic tacrolimus trough concentration in the post transplantation period Renal allograft function returned to CKD 1 or 2 Hepatic function within normal limits Hb more than 10 Willing to comply with the study procedures by providing written informed consent
Exclusion criteria
Exclusion criteria: Recipients of multi-organ transplantation Concurrent use of drugs altering tacrolimus pharmacokinetics other than prednisolone Patients have been started on ketoconazole or diltiazem due to non-attainment of desired trough concentration Active infections at enrolment or within 30 days prior to enrolment Acute transplant rejection episodes Ongoing diarrheal episodes Patients harbouring HIV and hepatitis B or C infection Suffering from any malignancy requiring recent surgery or chemotherapy or irradiation Patients who had received any investigational drug within past six months History of hypersensitivity to piperine or tacrolimus or MMF Pregnant women or nursing mothers or women of childbearing potential without an effective method of birth control
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Cmax (maximum plasma concentration) Changes in Tmax (time to reach Cmax) Changes in AUC 0-12 h (area under the concentration-time curve from 0 to 12 hours)Timepoint: Baseline and 1 week post intervention administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Ka Changes in Kel Changes in clearance AUC 0-12 h of piperine at steady state Incidence and severity of adverse events related to the combination of tacrolimus, MMF, and piperine Changes in vital signs, clinical laboratory parameters, or other safety markers over the study durationTimepoint: After one week of intervention and patients will be in close follow up at least for the next three months | — |
Countries
India
Contacts
Public ContactYazhini R
Post Graduate Institute of Medical Education and Research Chandigarh
Outcome results
None listed