Clinical trial NCT02963103: A Study to Assess the Safety and Efficacy of a Tacrolimus Based Immunosuppressive Regimen in Stable Kidney Transplant Recipients Converted From Cyclosporine Based Immunosuppressive Regimen
Official title: A Single-center Pilot Study to Assess the Safety and Efficacy of a Tacrolimus Based Immunosuppressive Regimen in Stable Kidney Transplant Recipients Converted From Cyclosporine Based Immunosuppressive Regimen
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Kidney Transplantation
Keywords: Tacrolimus
Kidney transplantation
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2016-11-15
Enrollment: 13
Sex: ALL
Minimum age (years): 20
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 observe and evaluate the change in renal function following conversion from cyclosporine-based immunosuppressive regimen to tacrolimus-based one.


Eligibility criteria: Inclusion Criteria:

* Patients received a kidney transplant at least 12 months before enrollment.
* Patients whose dosage of previous immunosuppressants has not been changed and remained for at least 4 weeks before enrollment, and blood trough level of cyclosporine is 100 to 200 ng/mL.
* Patients who have the side effects (hypertension, hyperlipidemia, gingival hyperplasia and hypertrichosis/hirsutism) during use of cyclosporine.
* Serum creatinine \< 2.3 mg/dl at enrollment
* Female patients of childbearing potential must have a negative serum pregnancy test prior to enrollment, and agreed to use effective contraception during the trial.
* Patients considered clinically stable

Exclusion Criteria:

* Patients who have previously received an organ transplant other than a kidney.
* Patients who have had acute transplant rejection within 12 weeks, or acute transplant rejection requiring antilymphocyte therapy within 24 weeks prior to enrollment.
* Patients newly diagnosed malignant tumors after organ transplant, but the patients treated completely with basal or squamous cell carcinoma of the skin are excepted.
* Patients who have an underlying disease such as focal segmental glomerulosclerosis (FSGS) or type II membranoproliferative glomerulonephritis (Type II MPGN).
* Proteinuria \> 2 g/24 hrs.
* Patients who have "Creeping creatinine" (a 20% increase in their creatinine for six months before their enrollment).
* Patients whose Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) is twice higher than the normal range in the center.
* Patients who have liver cirrhosis.
* Patients who are pregnant or breastfeeding.
* Patients who had been HIV-positive.
* Patients who have a known allergy to Prograf® or its ingredients, steroids or adjuvants.
* Patients who have an unstable medical condition that may affect the evaluation of the study's objectives.
* Patients who are receiving prohibited concomitant medications or who received those medications within 28 days of their enrollment.
* Patients who are currently participating in another clinical trial or who received the investigational drug in another trial within 28 days of their enrollment.
* Patients who are at the risk of drug abuse or mental disorders or communicate difficulties.

Primary outcomes:
measure: Change from baseline in GFR
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Change from baseline in total cholesterol
timeFrame: Baseline and Week 24
measure: Change from baseline in Triglycerides
timeFrame: Baseline and Week 24
measure: Change from baseline in LDL
timeFrame: Baseline and Week 24
measure: Change from baseline in HDL
timeFrame: Baseline and Week 24
measure: Change from baseline in the number of antihyperlipidemic drugs
timeFrame: Baseline and Week 24
measure: Change from baseline in blood pressure
timeFrame: Baseline and Week 24
measure: Change from baseline in the number of antihypertensive drugs
timeFrame: Baseline and Week 24
measure: Change from baseline in number of participants who have had hirsutism
timeFrame: Baseline and Week 24
measure: Change from baseline in number of participants who have had gingival hypertrophy
timeFrame: Baseline and Week 24
measure: Overall incidence rate of adverse events
timeFrame: up to Week 24
measure: Proportion of participants with patient survival
timeFrame: up to Week 24
measure: Proportion of participants with organ survival
timeFrame: up to Week 24
measure: Acute rejection rate confirmed by biopsy
timeFrame: up to Week 24
measure: Ratio of mean dose of cyclosporine to tacrolimus
timeFrame: up to Week 24
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: KR00001
Study officials:
affiliation: Astellas Pharma Korea, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: