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Minimization of Immunosuppressant Dose in Liver Transplant Recipients by T-Lymphocyte Immune Functional Assay

Individualization of Immunosuppression in Liver Transplant Recipients by T-Lymphocyte Immune Functional Assay: Multi-center, Prospective, Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONRC-11001688
Enrollment
Unknown
Registered
2011-10-25
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

Group 2: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) respectively

Sponsors

Shanghai Jiao-tong University School of Medicine Renji Hospital
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. Age 65years old; 2. Post liver transplantation within 1 year; 3. Absolute WBC count less than 2000 per micro liter; 4. Concurrently intake immunomodulating drugs (e.g. Zadaxin, Aweto, Glossy ganoderma); 5. Patient is not eligible for enrollment according to Clinicians' judgment; 6. Withdraw the informal consent.

Design outcomes

Primary

MeasureTime frame
Incidence of biopsy proven acute rejection (AR) or clinical AR at the endpoint of the trial;

Secondary

MeasureTime frame
Incidence and time point of acute rejection; frequency of acute rejection; incidence of infection;

Countries

China

Contacts

Public ContactQiang Xia
xiaqiang@medmail.com.cn+86 021 68383775

Outcome results

None listed

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