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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01680952
First received: September 4, 2012
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Kidney Transplant Patients
Drug: A) TEST
Drug: B) CONTROL
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Failure rate in effectiveness of up to 12 months after kidney transplant [ Time Frame: 12 months after kidney transplant ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A) TEST Drug: A) 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.

Other Name: 1. Test group : Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®)
Drug: B) 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
Other Name: 2. Control group: Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil
Experimental: B) CONTROL Drug: A) 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.

Other Name: 1. Test group : Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®)
Drug: B) 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
Other Name: 2. Control group: Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01680952

Contacts
Contact: YU SEUN KIM, MD +82 2 2228 0453 smile@yuhs.ac

Locations
Korea, Republic of
Ajou Univeristy Medical Center Recruiting
Suwon, KyungKi Province, Korea, Republic of
Contact: Chang Kwon Oh, MD    82-31-219-5758    dr.ohchangkwon@gmail.com   
Kyungpook national hospital Recruiting
Daegu, Korea, Republic of
Contact: Chan Duck Kim    053-420-5560    drcdkim@knu.ac.kr   
Severance hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Yu Seun Kim, MD, PhD    82-2228-2115    yukim@yuhs.ac   
Gangnam Severance hospital Recruiting
Seoul, Korea, Republic of
Contact: Man Ki Ju    02-2019-3893    mkju@yuhs.ac   
Seoul National University hospital Recruiting
Seoul, Korea, Republic of
Contact: JongWon Ha, MD    82-2-2072-2991    jwhamd@snu.ac.kr   
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Contact: Cheol Woong Jung, MD    82-2-920-6858    cheolwoongjung@gmail.com   
Ulsan Univ Hospital Recruiting
Ulsan, Korea, Republic of
Contact: Hong Rae Cho    052-250-7004    hrcho@uuh.ulsan.kr   
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01680952     History of Changes
Other Study ID Numbers: 4-2011-0920
Study First Received: September 4, 2012
Last Updated: August 12, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yonsei University:
RECORD study

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Sirolimus
Everolimus
Tacrolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents

ClinicalTrials.gov processed this record on August 28, 2014