Extended Release Tacrolimus on Intrapatient Variability in Kidney Transplant Recipients

Impact of Once-daily Extended Release Tacrolimus on Intrapatient Variability of Trough Level in Kidney Transplant Recipients

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211221053480N1

Enrollment

100

Registered

2022-04-10

Start date

2022-04-04

Completion date

Unknown

Last updated

2022-05-02

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

Conditions

Kidney transplantation. Kidney transplant status

Interventions

Intervention group:In selected patients, convert Prograf®- Astellas to Advagraf®- Astellas : A 1:1 conversion from immediate-release tacrolimus to extended-release tacrolimus capsules and treatment wi

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Kidney transplantation alone At least 6 months post transplantation Stable graft function Stable Tacrolimus dosage Coefficient variation of drug level >30% On tacrolimus twice daily Tacrolimus+MPA+prednisolone regime

Exclusion criteria

Exclusion criteria: History of acute rejection within 3 months Active infection Not willing to participate Participating in other trials

Design outcomes

Primary

Measure	Time frame
Coefficient variation of drug level. Timepoint: 3 months after conversion. Method of measurement: Drug level measurement with HPLC technique monthly and calculating coefficient variation.	—

Secondary

Measure	Time frame
Graft function. Timepoint: 3 months after conversion. Method of measurement: GFR with creatinine based formula (CKD-EPI).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShiva Samavat

Shahid Beheshti University of Medical Sciences

shsamavat@gmail.com+98 21 2258 0333

Outcome results

None listed

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