A Study to Evaluate the Efficacy and Safety in Kidney Transplant Recipients When Changed From Cyclosporine to Tacrolimus Prolonged-release Capsule or Tacrolimus Capsule

Astellas

Status and phase

Terminated

Phase 4

Conditions

Kidney Transplant Recipients

Treatments

Drug: Advagraf

Drug: Prograf

Study type

Interventional

Funder types

Industry

Identifiers

NCT02268201

ACNKTxCon

Details and patient eligibility

About

KTx recipients receiving cyclosporine-based immunosuppressive therapy, and in the opinion of the investigator would benefit from switch to a tacrolimus-based immunosuppression, will switch the immunosuppressive therapy to a tacrolimus-based one. Efficacy and safety of patients will be observed for 52 weeks.

Full description

The primary objective of this study is to compare the adherence of kidney transplant recipients treated with Prograf and Advagraf regimens.

The secondary objectives of this study are:

To compare the renal function (eGFR) in KTx recipients treated with Cyclosporine and Tacrolimus regimens.
To compare the QoL of KTx recipients treated with Cyclosporine and Tacrolimus regimens.
To compare the efficacy of Cyclosporine and Tacrolimus regimens in KTx recipients.
To compare the safety of Cyclosporine and Tacrolimus regimens in KTx recipients.

Enrollment

17 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients have received cyclosporine-based immunosuppressive therapy for more than 6 months， and have maintained a stable regimen for at least 8 weeks before enrollment
The trough blood level of cyclosporine maintained at 50-200ng/ml at least 4 weeks before enrollment
SCr< 200 μmol/l ( 2.3 mg/dl)
Females of childbearing potential must have a negative pregnancy test within 48 hrs prior to randomization and reliable methods of contraception should be started 4 weeks prior to and during the whole study
Understand and sign the approved informed consent form

Exclusion criteria

Patients who have had other solid organ transplantations
24 hours proteinuria>2g
SGPT/ALT，SGOT/AST or total bilirubin rising to more than double the normal level
Patients suffering from serious infection lesions
Patients have severe diarrhea or vomiting, peptic ulcer and/or defective absorption
Patients have severe heart, lung disease, abnormal glucose tolerance or malignant tumor history
Known contraindication to administration of Tacrolimus. Subject has known hypersensitivity to tacrolimus, or any of the product excipients
Pregnancy or lactating women
Patients have participated in another clinical trial in the past month
Patient refuses to sign informed consent form
Patient not willing to continue in the study and wants to withdraw from the study
Poor adherence or lost to follow-up
Violation of protocol
Severe adverse events occurred need to withdraw the study according to investigator's judgment
Pregnancy