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Rapid Achievement of Target Tacrolimus Concentrations with Extended-Release Formulation: A Single-Center, Prospective, Open-Label, Randomized Controlled Study

Rapid Achievement of Target Tacrolimus Concentrations with Extended-Release Formulation: A Single-Center, Prospective, Open-Label, Randomized Controlled Study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125220
Enrollment
Unknown
Registered
2026-05-22
Start date
2025-09-02
Completion date
Unknown
Last updated
2026-05-25

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

Conditions

Immune rejection after kidney transplantation

Interventions

Control group:Standard-dose extended-release tacrolimus regimen
Loading-dose extended-release tacrolimus group:Loading-dose extended-release tacrolimus regimen

Sponsors

Southern Medical University Southern Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Written informed consent provided voluntarily; 2.Patients undergoing first allogeneic kidney transplantation at Nanfang Hospital, Southern Medical University; 3.Age between 18 and 65 years; 4. CYP3A5 genotype is slow metabolizer.

Exclusion criteria

Exclusion criteria: 1.Concomitant use of medications significantly affecting CYP3A4 metabolism (except corticosteroids), such as voriconazole, ketoconazole, and macrolide antibiotics; 2.History of previous organ transplantation; 3.Use of tacrolimus, cyclosporine, sirolimus, or everolimus within 3 months prior to enrollment; 4.Panel reactive antibody (PRA) > 30%; 5.Any condition judged by investigators to make the patient unsuitable for participation in this study;

Design outcomes

Primary

MeasureTime frame
Tacrolimus whole blood trough concentration (C?);

Secondary

MeasureTime frame
Urinalysis parameters;Renal function parameters;Incidence of delayed graft function (DGF) in transplanted kidneys;

Countries

China

Contacts

Public ContactMiao Yun

Southern Medical University Southern Hospital

miaoyunecho@126.com+86 20 6164 1786

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026