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Pharmacodynamic monitoring of Phospho-NFAT1 in kidney transplant recipients treated with tacrolimus

Pharmacodynamic monitoring of Phospho-NFAT1 in kidney transplant recipients treated with tacrolimus

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300077146
Enrollment
Unknown
Registered
2023-10-31
Start date
2023-11-01
Completion date
Unknown
Last updated
2023-11-06

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

Conditions

kidney transplantation

Interventions

Healthy Subjects:Not Applicable
Kidney transplant recipients:Not Applicable

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Healthy Subjects: (1)Male or female, between 18 and 60 years (inclusive); (2)Body weight=45.0 kg (female), Body weight=50.0 kg (male); (3)Body mass index (BMI): 18.0kg/m2~28.0 kg/m2; (4)Vital signs do not indicate any clinically significant abnormality (5)Not participating in any clinical trial within 4 weeks before blood collection; (6)No blood donation within 4 weeks prior to blood collection, or blood donation/loss =200ml; (7)Not taking any medication within 2 weeks before blood collection, including prescription drugs, over-the-counter drugs, Chinese herbal medicines, or vitamins; (8)No history of fainting during acupuncture or with blood . Kidney transplant recipients: (1)Male or female,between 18 and 90 years (inclusive); (2)Subjects receiving immunosuppressive therapy (with or without tacrolimus) for kidney transplantation; (3)Subjects volunteered for the study and signed informed consent;

Exclusion criteria

Exclusion criteria: Healthy Subjects: (1) Subjects in whom a ECG tracing in the past history or at screening visit showed a clinically significant abnormality; (2) Subjects with a past or current history of severe cardiovascular, lung, liver, kidney, blood, gastrointestinal, endocrine, immune, skin, neurological or psychiatric diseases, or infectious diseases; (3) Subjects with a history of major surgical procedures or severe trauma. (4) Subjects with a history of malignant tumors in any organ system within the past 5 years, whether treated or untreated, and whether there is evidence of local recurrence or metastasis. (5) Subjects in whom a clinically significant abnormality in the laboratory examination; (6) Subjects who have a history of alcoholism or drug/chemical abuse in the past year; (7) Female who is pregnant, breast-feeding or during menstruation when collecting blood; (8) Subjects with communication barriers, poor compliance or non-cooperation behaviors, or other reasons unsuitable for participation in this study, as judged by the investigator. Kidney transplant recipients: (1)Subjects with serious or uncontrollable chronic diseases, such as severe cerebrovascular diseases and malignant tumors; (2)Female who is pregnant or breast-feeding, male or female who is preparing for fertility during the study; (3)Other conditions unfit for participation in this study at the discretion of the investigator.

Design outcomes

Primary

MeasureTime frame
nuclear factor of activated T cells 1;

Countries

People’s Republic of China

Contacts

Public ContactXuemei He

Beijing Hospital

mhsg_mh@163.com+86 10 8513 3632

Outcome results

None listed

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