Clinical trial NCT02268201: A Study to Evaluate the Efficacy and Safety in Kidney Transplant Recipients When Changed From Cyclosporine to Tacrolimus Prolonged-release Capsule or Tacrolimus Capsule
Official title: A Randomized, Open-label, Multi-center Clinical Trial to Compare Efficacy and Safety of Cyclosporine-based and Switching Cyclosporine to Tacrolimus of Two Forms-based Immunosuppressive Therapy in Renal Transplant (KTx) Recipients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Kidney Transplant Recipients
Keywords: tacrolimus
immunosuppressive therapy
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-10-20
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: medication adherence
timeFrame: Up to 52 weeks after switching
Secondary outcomes:
measure: endogenous creatinine clearance rate (Ccr)
timeFrame: Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52
measure: Calculated glomerular filtration rate
timeFrame: Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52
measure: blood lipids
timeFrame: Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52
measure: liver function (AST, ALT and bilirubin)
timeFrame: Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52
measure: fasting blood-glucose (FBG)
timeFrame: Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52
measure: Safety assessed by the incidence and severity of adverse events
timeFrame: Up to 52 weeks after switching
Other outcomes:
Locations:
city: Beijing
country: China
city: Fuzhou
country: China
city: Guangzhou
country: China
city: Jinan
country: China
city: Nanchang
country: China
city: Shanghai
country: China
city: Xi'an
country: China
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: