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A clinical trial to adjust the dose of Tacrolimus in renal transplant patients with fast liver metabolism

Tacrolimus dose optimization in pre and post renal transplant patients with high hepatic drug metabolism(CYP4503A5 polymorphic genotype) by therapeutic drug monitoring

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/02/049758
Enrollment
600
Registered
2023-02-15
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

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

Conditions

Health Condition 1: N186- End stage renal disease Health Condition 2: N186- End stage renal disease Health Condition 3: N186- End stage renal disease Health Condition 4: N186- End stage renal disease Health Condition 5: N186- End stage renal disease

Interventions

None listed

Sponsors

IQRAA INTERNATIONAL HOSPITAL AND RESEARCH CENTER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: First objective- All pre and post-renal transplant patients willing to participate in the study. Second objective- patients found to be extensive metabolizer for tacrolimus on genotyping.

Exclusion criteria

Exclusion criteria: Patients not willing/cooperative for the study. Patients who are on other drugs which interfere with the tacrolimus level. Patients with abnormal LFT and patients who are not available for follow up.

Design outcomes

Primary

MeasureTime frame
Assessment of pharmacokinetic, and pharmacodynamic actions of the drug among extensive metabolizers Timepoint: Between two patient visits with an interval of one month.

Secondary

MeasureTime frame
Tacrolimus maximum blood levelsTimepoint: will be measured 1.5 hours after the dose administration.

Countries

India

Contacts

Public ContactRatheeshkumar NM

Lovely Professional University

rajan.26188@lpu.co.in9646396500

Outcome results

None listed

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