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Effects of conversion of tacrolimus capsules from conventional to sustained-release formulations on serology and intestinal flora of kidney transplant recipients

Effects of conversion of tacrolimus capsules from conventional to sustained-release formulations on serology and intestinal flora of kidney transplant recipients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400087659
Enrollment
Unknown
Registered
2024-08-01
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-08-05

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

Conditions

Allogeneic kidney transplantation

Interventions

Case series:None

Sponsors

The Second Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Overall inclusion criteria: (1) Age 18-65 years old; (2) Receiving a kidney transplant for the first time; (3) The transplantation time exceeds 3 months; (4) The immunosuppression regimen for nearly 1 month was stable, and the renal function was stable. Exclusion criteria for intestinal flora indicators: (Changes in intestinal flora of patients are not observed in the following circumstances) (1) Acute/chronic rejection, infection, graft loss, gastrointestinal symptoms, etc., occurred during the study; (2) Concurrent use of related drugs that affect tacrolimus metabolism (except immunosuppressants) within 1 week; (3) Antibiotics, antifungal drugs and probiotics have been used within 4 weeks.

Exclusion criteria

Exclusion criteria: Exclusion criteria for intestinal flora indicators: (Changes in intestinal flora of patients are not observed in the following circumstances) (1) Acute/chronic rejection, infection, graft loss, gastrointestinal symptoms, etc., occurred during the study; (2) Concurrent use of related drugs that affect tacrolimus metabolism (except immunosuppressants) within 1 week; (3) Antibiotics, antifungal drugs and probiotics have been used within 4 weeks.

Design outcomes

Primary

MeasureTime frame
Human kidney survival rate;incidence of acute rejection;incidence of delayed recovery of transplant function;incidence of transplant kidney failure;incidence of recipient mortality;

Secondary

MeasureTime frame
Tacrolimus drug concentration;Blood routine examination;Blood biochemistry;Ultrasound examination of the transplanted kidney;Intestinal flora;

Countries

China

Contacts

Public ContactLiu Kailong

The Second Hospital Of Hebe Medical University

27600433@hebmu.edu.cn+86 185 3113 7376

Outcome results

None listed

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