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Types of polymorphism of liver enzyme CYP3A5 and MDR-1 and their effect on dose calculaiton of drug Tacrolimus in kidney transplant patients

Pattern of CYP3A5 and MDR-1 single nucleotide polymorphism and its Impact on Individualization of Tacrolimus based Immunosuppression in Living Renal Allograft recipient

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/03/007997
Enrollment
150
Registered
2017-03-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Chronic Kidney Disease patients on maintenance hemodialysis

Interventions

Intervention1: Genotype based dose of Tacrolimus: Oral, Genotype based dose of Tacrolimus calculated as per weight of patient for one year, twice a day. Control Intervention1: Standard dose of Tacroli

Sponsors

AIIMS Research Grant
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients being planned for renal transplant surgery

Exclusion criteria

Exclusion criteria: ABO incompatible and deceased renal transplant

Design outcomes

Primary

MeasureTime frame
The graft outcome will be assessed in terms of acute cellular rejection, acute antibody mediated rejection, calcineurin inhibitor toxicity, unexplained rise in serum creatinine, hypertension, hyperglycemia and opportunistic infection. The time to achieve therapeutic drug level of tacrolimus will be assessed in days anddifference in total dose of tacrolimus in different polymorphic patientswill be assessed in mg/day.Timepoint: 3 days, 7 days, 14 days, 1 month, 3 month, 6 month and 12 month

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

India

Contacts

Public ContactDr Raj Kanwar Yadav

All India Institute of Medical Sciences

rkyadavnephrology@gmail.com9868397403

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026