Clinical trial NCT01680952: Study to Evaluate the Safety and Efficacy of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), Versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate Mofetil in Kidney Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplant Patients
Keywords: RECORD study
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-09-07
Enrollment: 158
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the efficacy and safety of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil in Kidney Transplant Patients.


Eligibility criteria: Inclusion Criteria:

* Male or female patients aged over 20 years
* Patient who is judged would have the benefits of the Extended Release Tacrolimus (Advagraf®)treatment by the investigator
* Patients has given written informed consent
* Patient is a recipient of primary or recipient of primary (a living kidney transplant, a cadaveric donor.)
* Patients has received an ABO compatible donor kidney.
* Complement-dependent Cytotoxic Crossmatch: CDC) result: negative
* Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment or upon hospitalization

Exclusion Criteria:

* Patient has previously received an organ transplant other than a kidney.
* Patient has a known hypersensitivity to tacrolimus, Sirolimus (Rapamune®),Mycophenolate mofetil.
* Desensitization
* HLA-identical
* Heart Disease; Heart failure (symptom, EF \<45%)
* Lung Disease; Significant chronic obstructive pulmonary disease, restrictive lung disease
* Patient has an uncontrolled concomitant infection (including Hepatitis B, Hepatitis C) or any other unstable
* malignant tumor history in the 5years prior to enrollment. (except,squamous cell carcinoma)
* Patient has received a kidney transplant from non-heart beating donor
* Cold ischemic time \> 30hrs
* Elevated AST and/or ALT levels greater than 3 times the upper value of the normal range of the investigational site
* (ANC)\<1,500/mm3, (WBC)\<2,500/ mm3, (PLT)\<100,000/ mm3
* ATG: Anti-thymocyte globulin induction
* Medical condition that could interfere with the study objectives.
* Patient is currently taking or has been taking an investigational products in the 30 days prior to enrollment.
* Patient is currently taking or has been taking an prohibited medications in the 28 days prior to enrollment.
* Patient who is judged not to be adequate by the investigator owing to other reasons
* Patient is pregnant or lactating.
* Recipient or donor is known to be seropositive for human immunodeficiency virus.(HIV)

Primary outcomes:
measure: Failure rate in effectiveness of up to 12 months after kidney transplant
timeFrame: 12 months after kidney transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou Univeristy Medical Center
state: KyungKi Province
city: Daegu
country: Korea, Republic of
facility: Kyungpook national hospital
city: Seoul
country: Korea, Republic of
facility: Severance hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan Univ Hospital
Study officials:
References:
citation: Huh KH, Lee JG, Ha J, Oh CK, Ju MK, Kim CD, Cho HR, Jung CW, Lim BJ, Kim YS; RECORD Study. De novo low-dose sirolimus versus mycophenolate mofetil in combination with extended-release tacrolimus in kidney transplant recipients: a multicentre, open-label, randomized, controlled, non-inferiority trial. Nephrol Dial Transplant. 2017 Aug 1;32(8):1415-1424. doi: 10.1093/ndt/gfx093.