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Impact of Genetic factors on Tacrolimus dosing

Pharmacometric and Pharmacogenomic Integration for Precision Dosing of Tacrolimus

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/06/025498
Enrollment
60
Registered
2020-06-01
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: N990- Postprocedural (acute) (chronic) kidney failure

Interventions

None listed

Sponsors

Manipal College of Pharmaceutical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who are on tacrolimus therapy in the department of Nephrology. 2. These patients are stable and willing to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Patients who underwent multiorgan transplantation. 2. Patients under the age of 18

Design outcomes

Primary

MeasureTime frame
1. Cyp3A5 genotyping 2. Tacrolimus concentration will be estimated from whole blood. 3. Factors influencing Tacrolimus Pharmacokinetics will be identified. 4. Population pharmacokinetic model will be developed using the factors that affect tacrolimus kinetics.Timepoint: 1. Genotyping for Cyp3A5 will be performed within 6 months from recruitment of the subject. 2. Tacrolimus concentration will be estimated during 3 regular follow up visits to the hospital from the date of recruitment. 3. Factors influencing Tacrolimus Pharmacokinetics will be identified within 36 months from the initiation of the study. 4. Population pharmacokinetic model will be developed within 36 months from the initiation of the study.

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

India

Contacts

Public ContactSurulivelrajan M

Manipal academy of higher education

msv.rajan@manipal.edu9886921414

Outcome results

None listed

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