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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-23

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Kidney Transplant Recipients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ADV group

Once daily

Group Type EXPERIMENTAL

Advagraf

Intervention Type DRUG

oral

PRG group

Twice daily

Group Type EXPERIMENTAL

Prograf

Intervention Type DRUG

oral

Interventions

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Advagraf

oral

Intervention Type DRUG

Prograf

oral

Intervention Type DRUG

Other Intervention Names

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Tacrolimus prolonged-release capsule Tacrolimus capsule

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No