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CompletedNCT01680952Updated Mar 8, 2016

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

A Phase 4 interventional study of A) TEST and B) CONTROL in Kidney Transplant Patients, sponsored by Yonsei University. Completed at 7 sites in South Korea. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2016-03-08.

Sponsored by Yonsei University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
158
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Kidney Transplant Patients

Keywords

  • RECORD study
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In context

Lead sponsor

Yonsei University is the lead sponsor of 1,410 studies on the registry; 235 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
158 participants (actual)

Study arms

  • Active comparator
    A) TEST

    Drug: A) TEST · Drug: B) CONTROL

  • Experimental
    B) CONTROL

    Drug: A) TEST · Drug: B) CONTROL

Interventions

  • DrugA) TEST

    1. Extended Release Tacrolimus (Advagraf®) ① Living The day before surgery: 0.2 mg/kg(morning dose) po, qd Morning on the day of surgery: 0.1 mg/kg po, qd After surgery, the capacity is adjusted according to the trough level. clinical significance, electrolyte level. ② Cadaveric Before surgery at once : 0.1 mg/kg within 12hours before surgery. After surgery : 0.2mg/kg po. in the morning After that, the capacity is adjusted according to the trough level. clinical significance, electrolyte level. 2. Sirolimus (Rapamune®): After surgery : 2mg/kg po. within 24hrs after reperfusion. After that, the capacity is adjusted according to the trough level.

    Also known as: 1. Test group : Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®)

  • DrugB) CONTROL

    1. Extended Release Tacrolimus (Advagraf®) : Same as above. 2. Mycophenolate mofetil : After surgery : 500mg/kg po. within 24hrs after reperfusion. After that, daily dose: 1000mg bid

    Also known as: 2. Control group: Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil

06

What researchers measure

Primary outcomes

  1. Failure rate in effectiveness of up to 12 months after kidney transplant

    1. Biopsy confirmed acute rejection 2. Subjects and graft survival 3. Glomerular filtration rate (GFR) 4. 24-hour urine test results at 12 months after kidney transplant: Urine protein, CrCl.

    Time frame: 12 months after kidney transplant

07

Study locations

7 sites
  • Kyungpook national hospital
    Daegu, Daegu, South Korea
  • Ajou Univeristy Medical Center
    Suwon, KyungKi Province, South Korea
  • Severance hospital
    Seoul, Seoul 120-752, South Korea
  • Gangnam Severance hospital
    Seoul, Seoul, South Korea
  • Korea University Anam Hospital
    Seoul, Seoul, South Korea
  • Seoul National University hospital
    Seoul, Seoul, South Korea
  • Ulsan Univ Hospital
    Ulsan, Ulsan, South Korea
08

References and documents

Publications

  • 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. PubMed 28810721 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01680952
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Sep 7, 2012
Start date
Sep 2012
Primary completion
Jan 2016
Completion
Jan 2016
Last update
Mar 8, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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