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The clinical study on the distribution of CYP3A5 polymorphism in Chinese infants and its guiding effect on application of CNI in pediatric liver transplantation

Influence of CYP3A5, ABCB1, and ACE polymorphism on tacrolimus dosing requirement and impact on acute rejections and nephrotoxicity after liver transplantation in Chinese pediatric living-donor liver transplant patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-16008040
Enrollment
Unknown
Registered
2016-03-02
Start date
2011-10-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

liver transplantation

Interventions

experimental group and control group:experimental group and control group adjust immunosuppressant dosage according to ImmuKnow ATP value (200-300 ng/mL) or tacrolimus trough levels (5-8 ng/mL) respec

Sponsors

Renji Hospital, Shanghai JiaoTong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Male and female (approximately equal in number), aged from 18-65 years old; 2. Clinically stable liver recipients over 1 year; 3. Living donor or cadaveric liver transplant recipients; 4. Stable liver recipients who can come to outpatient clinic and take blood test regularly; 5. Planned immunosuppressive regimen: according to each transplantation center; 6. Participate in the study voluntarily.

Exclusion criteria

Exclusion criteria: 1. Post liver transplantation within 1 year; 2. Absolute WBC count less than 2000 per micro liter; 3. Concurrently intake immunomodulating drugs (e.g. Zadaxin, Aweto, Glossy ganoderma); 4. Patient is not eligible for enrollment according to Clinicians' judgment; 5. Withdraw the informal consent.

Design outcomes

Primary

MeasureTime frame
Incidence of acute rejection. (biopsy proven or clinical AR);

Secondary

MeasureTime frame
Incidence and time point of acute rejection; frequency of acute rejection; incidence of infection; patient and the graft survival rate; the variation of blood glucose, creatine, and pressure.;

Countries

China

Contacts

Public ContactXIA Qiang
xiaqiang@shsmu.edu.cn+86 21 68383775

Outcome results

None listed

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