Clinical trial NCT02706678: Efficacy and Safety Study of the Switch From Cyclosporin to Tacrolimus in Renal Transplant Recipients
Official title: Efficacy and Safety of a Post-transplantation Switch From Cyclosporin to Tacrolimus Sustained-release Capsules in Renal Transplant Recipients: A Multi-center, Open-label, Uncontrolled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Transplant Recipients
Keywords: FK506
Renal transplant recipients
cyclosporin
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2016-03-11
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the effects of tacrolimus sustained-release capsules replacing cyclosporin on kidney function of renal transplant recipients.


Eligibility criteria: Inclusion Criteria:

* 18-65 years of age, male or female
* 1-5 years after kidney transplantation
* The patient has been accepting cyclosporin-based immunosuppressive therapy for ≥6 months, and the therapeutic regimen has kept stable for at least 4 weeks before inclusion
* The dose of cyclosporin has kept stable for at least 4 weeks before inclusion
* At least one of the cyclosporin-related adverse reactions is present or the answer to the 5th question in the questionnaire is "Yes" at the time of inclusion:
* gingival hyperplasia and treatment requested by the patient
* polytrichia and interventional therapy requested by the patient
* post-transplantation hypertension
* post-transplantation hyperlipemia (total cholesterol\>5.7 mmol/L (220 mg/dl))
* Serum creatinine\<200 μmol/l ( 2.3 mg/dl)
* A promise is made to take contraceptive measures during the study (women at childbearing ages).

Exclusion Criteria:

* Patients having accepted transplantation of other organs apart from kidney transplantation
* Patients with 24-hour urine protein\>2 g
* Patients with SGPT/ALT, SGOT/AST or total bilirubin continually increasing to more than twice the normal value(s)
* Patients with refractory infectious foci
* Patients with serious diarrhea or vomiting, active upper gastrointestinal ulcers or malabsorption
* Patients with serious heart or lung diseases or history of sugar tolerance abnormality or malignant tumors
* Patients allergic to tacrolimus or other basic medications
* Pregnant or lactating women
* Patients having participated in other clinical trials within the previous month
* Other patients who are considered by doctors unsuitable for the study

Primary outcomes:
measure: Change from baseline in creatinine level
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Change from baseline in creatinine level
timeFrame: Baseline and Weeks 1, 2, 4, 8 and 12
measure: Incidence of rejection reaction after drug use
timeFrame: Up to Week 24
measure: Plasma concentrations of tacrolimus
timeFrame: Weeks 1, 2, 4, 8, 12 and 24
measure: Change from baseline in blood pressure
timeFrame: Baseline and Weeks 1, 2, 4, 8, 12 and 24
measure: Change from baseline in blood lipid
timeFrame: Baseline and Weeks 1, 2, 4, 8, 12 and 24
measure: Change from baseline in liver function
timeFrame: Baseline and Weeks 1, 2, 4, 8, 12 and 24
measure: Change from baseline in fasting blood glucose
timeFrame: Baseline and Weeks 1, 2, 4, 8, 12 and 24
measure: Change from baseline in gingival hyperplasia
timeFrame: Baseline and Week 24
measure: Change from baseline in polytrichia
timeFrame: Baseline and Week 24
measure: Safety assessed by Adverse Events
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
city: Changchun
country: China
city: Chengdu
country: China
city: Guangzhou
country: China
city: Nanjing
country: China
city: Nanning
country: China
city: Shanghai
country: China
city: Shenyang
country: China
city: Wuhan
country: China
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: