Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Efficacy and Stability of Information and Communication Technology Based Centralized Clinical Trial Monitoring System of Adherence to Immunosuppressive Medication in Kidney Transplant Recipients
Brief Summary: Immunosuppression non-adherence in kidney transplant recipients (KTRs) not only increases the risk of medical intervention due to acute rejection and graft loss but burdens the socioeconomic system in the form of increased healthcare cost. Aggressive preemptive effort by healthcare professionals geared to ensure adherence to immunosuppressants in KTRs is significant and imperative.

This study was designed as a prospective, randomized, controlled, and multicenter study aimed at evaluating efficacy and stability of the information and communication technology (ICT)-based centralized monitoring system in boosting medication adherence in KTRs.

This study is based upon work supported by the Ministry of Trade, Industry \& Energy (MOTIE, Korea) under Industrial Technology Innovation Program ( No. 10059066, 'Establishment of ICT Clinical Trial System and Foundation for Industrialization').


Options:
A: Inclusion Criteria

1. Signed informed consent and or/assent
2. Between the ages of 18 and 70 years, inclusive
3. Current or future kidney transplant recipients, no more than 14 days after transplant and prior to hospital discharge. Inclusion of future kidney transplant recipients cannot exceed 30-days pre-transplant.
4. Able to swallow tablets and capsules at the time of randomization
5. Subjects must be receiving a primary or secondary kidney allograft from a deceased donor or from a non- HLA identical living donor
6. Negative cross match test, and compatible (A, B, AB or O) blood type
7. Subjects must have no known contraindications to tacrolimus
8. Women of childbearing potential (WOCBP) must have a negative pregnancy test and be willing to use 2 methods of contraception during the study and for 6 weeks after stopping the study drug.

WOCBP includes any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea ≥ 12 consecutive months; or women on hormone replacement therapy with documented serum follicle stimulating hormone level \> 35 mIU/cc). Women who are using oral, implanted, or injectable contraceptive hormones (intrauterine device), mechanical products or barrier methods (diaphragm, condoms, spermicides), are practicing abstinence, or have a sterile partner (e.g., vasectomy), will be considered of child bearing potential.

In addition, WOCBP who are taking MMF must use methods of birth control as stipulated in the package insert, namely:

Either intrauterine device, or partner with vasectomy, or one hormone (oral contraceptive pill, transdermal patch, vaginal ring, or progesterone injection or implant) and one barrier method (diaphragm or cervical cap with spermicide, contraceptive sponge, or male or female condom), or two barrier methods as described above.

WOCBP must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) at the time of transplant.

Exclusion Criteria

1. Those who receive simultaneous combined organ transplants
2. Subjects with clinically significant active infections (for example, those requiring hospitalization, or as judged by the Investigator) or malignancies
3. Recipients who are concurrently receiving belatacept or anticipate to receive belatacept as part of their immunosuppressive regimen
4. Subjects currently enrolled in another investigational device or drug study
5. WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for 6 weeks after stopping the study drug
6. Women who are breast-feeding or pregnant with a positive pregnancy test on enrollment or prior to study drug administration
7. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
8. Any psychiatric or medical condition that, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
B: Inclusion Criteria:

* 1 year after kidney transplantation
* out-patient follow up in Seoul National University Hospital
* using android smartphone
* taking Prograf as a main immunosuppressant
* 15-70 years

Exclusion Criteria:

* patients who cannot use medication event monitoring system
* multiorgan transplant
* immunosuppression medication change within 4 weeks of randomization
* caregiver management of the medication regimen
* pregnancy
* patients who can not use mobile application
C: Inclusion Criteria:

* Adults (≥22 years)
* Receive a kidney transplant at the Johns Hopkins Hospital

Exclusion Criteria:

* Non-English speaking participants
D: Inclusion Criteria:

1. Men and women aged 19 and over
2. At least 1 month lapsing from kidney transplantation
3. Stable renal function maintained after kidney transplantation(eGFR ≥ 30 mL/min/1.73m2)
4. History of kidney transplantation only and no other organs
5. Use of tacrolimus, mycophenolic acid, and steroids for post-transplant immunosuppression
6. Patients, with capability and willingness to give consent to trial participation, who have signed the informed consent form in compliance with due process and are capable of making office visits and taking part in the trial as required by the protocol.

Exclusion Criteria:

1. Patients' refusal of the ICT-based centralized home monitoring
2. History of treatment for acute rejection within the past 3 months
3. Active infectious disease
4. Uncorrected ischemic heart disease
5. Visual or auditory defects that could affect use of the smart pill box
6. Fingerprint authentication of personal identity deemed impossible (ex: adermatoglyphia)
7. Other reasons determined by investigators that make participation in the clinical trial inappropriate

Answer: D