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Effect of two different Tacrolimus formulations on drug levels and outcomes in kidney transplant patients

Comparative evaluation of dose-normalised Area Under Curve, Variability and Outcomes in stable kidney transplant recipients on Prolonged versus Immediate Release Tacrolimus - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110415
Enrollment
44
Registered
2026-05-12
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: Z940- Kidney transplant status

Interventions

Intervention1: Tacrolimus - Prolonged Release: 1 mg once daily, orally, for 6 months Control Intervention1: Tacrolimus - Immediate Release: 0.5 mg twice daily, orally, for 6 months

Sponsors

Nizams Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Living or deceased donor kidney transplant recipients More than one year post-kidney transplant status with stable graft function Ability and willingness to give written informed consent

Exclusion criteria

Exclusion criteria: Participation in any other investigational study within the preceding 3 months Known hypersensitivity to Tacrolimus.

Design outcomes

Primary

MeasureTime frame
Mean Dose-normalised Area Under CurveTimepoint: On Day 7—

Secondary

MeasureTime frame
Mean intrapatient variabilityTimepoint: Over 6 Months;Mean eGFRTimepoint: Over 6 months;Incidence of adverse eventsTimepoint: Over 6 months;Adherence using Morisky Medication Adherence Scale (MMAS - 8)Timepoint: At end of 6 months—

Countries

India

Contacts

Public ContactD Manisha

Nizams Institute of Medical Sciences, Punjagutta

cptnims@gmail.com7416512888

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026