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Retrospective cohort study and pharmacoeconomic study on the effectiveness and safety of tacrolimus capsules in immunosuppressive therapy for kidney transplant recipients

Retrospective cohort study and pharmacoeconomic study on the effectiveness and safety of tacrolimus capsules in immunosuppressive therapy for kidney transplant recipients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400082456
Enrollment
Unknown
Registered
2024-03-29
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

kidney transplantation

Interventions

Sponsors

Sichuan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: ? Recipient of the first kidney transplant ? Age = 18 years old ? Immunosuppressive therapy plan: Tacrolimus capsules (Sifukai® or Prograf®) + Mycophenolic acid drugs + Hormone triple immunosuppressive therapy plan

Exclusion criteria

Exclusion criteria: ? ABO incompatible transplantation ? Multi-organ transplantation ? Recipient of bilateral kidney transplantation ? Recipient of second or multiple kidney transplantation ? Subjects with severe and uncontrolled systemic infection and/or severe diarrhea, vomiting, active upper gastrointestinal disease that may affect tacrolimus absorption, or active peptic ulcer ? Recipients or donors known to be positive for HIV, HCV, or HBV ? Subjects receiving immunosuppressive drugs for any other indication besides transplantation ? Other cases deemed inappropriate for inclusion by the investigator due to missing key information or other reasons ? Patients who switched tacrolimus manufacturers during the current hospitalization period after kidney transplantation ? Subjects who failed to respond to three consecutive follow-up visits

Design outcomes

Primary

MeasureTime frame
Survival rate of transplant recipients at 24 months postoperatively;The survival rate of the transplanted organ at 24 months postoperatively;

Secondary

MeasureTime frame
Patient survival rate at 3, 6, and 12 months postoperatively;Graft survival rates at 3, 6, and 12 months postoperatively;Incidence rate of acute rejection reactions;Graft survival rate without acute rejection reactions at 24 months postoperatively;Cumulative incidence of chronic kidney allograft injury at 12 and 24 months postoperatively;Cumulative incidence of transplantation failure at 3, 6, 12, and 24 months postoperatively;Changes in renal function (blood creatinine, glomerular filtration rate, cystatin C) at 3, 6, 12, and 24 months postoperatively;Incidence rate of delayed graft function (DGF);

Countries

China

Contacts

Public ContactYang Hongji

Sichuan Provincial People's Hospital

hongjiyang@hotmail.com+86 189 8183 8973

Outcome results

None listed

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